Trial Outcomes & Findings for Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress (NCT NCT04562896)

Results Overview

Joint contact stress time exposure (MPA-s/gait cycle) was estimated using a participant specific musculoskeletal model. Peak joint contact stress time exposure (MPA-s/gait cycle) acting on the tibia during the gait cycle were reported. Lower peak contact stress time exposure is considered a better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

Baseline

Results posted on

2026-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1: NoCDO, CDOA, CDOB, CDOC Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: NoCDO, CDOA, CDOC, CDOB Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: NoCDO, CDOB, CDOA, CDOC Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: NoCDO, CDOC, CDOA, CDOB Participants will be evaluated without a CDO, then with CDOC, then with CDOA, then with CDOB. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO, CDOA, CDOB, CDOC Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: NoCDO, CDOA, CDOC, CDOB Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: NoCDO, CDOB, CDOA, CDOC Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO, CDOA, CDOB, CDOC Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOA, CDOC, CDOB Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOA, CDOC Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOC, CDOA, CDOB Participants will be evaluated without a CDO, then with CDOC, then with CDOA, then with CDOB. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOC, then with CDOB, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Overall Study STARTED	1	1	3	2	2	2	1	1	1	1	2	2	1	2
Overall Study COMPLETED	1	1	3	2	2	2	1	1	1	1	2	2	1	2
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Iterative Design of Custom Dynamic Orthoses to Reduce Articular Contact Stress

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: NoCDO, CDOA, CDOB, CDOC n=1 Participants Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: NoCDO, CDOA, CDOC, CDOB n=1 Participants Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: NoCDO, CDOB, CDOA, CDOC n=3 Participants Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: NoCDO, CDOC, CDOA, CDOB n=2 Participants Participants will be evaluated without a CDO, then with CDOC, then with CDOA, then with CDOB. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOC, then with CDOB, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO, CDOA, CDOB, CDOC n=2 Participants Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: NoCDO, CDOA, CDOC, CDOB n=2 Participants Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: NoCDO, CDOB, CDOA, CDOC n=1 Participants Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: NoCDO, CDOB, CDOC, CDOA n=1 Participants Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: NoCDO, CDOC, CDOA, CDOB Participants will be evaluated without a CDO, then with CDOC, then with CDOA, then with CDOB. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOC, then with CDOB, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO, CDOA, CDOB, CDOC n=1 Participants Participants will be evaluated without a CDO, then with CDOA, then with CDOB, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOA, CDOC, CDOB n=1 Participants Participants will be evaluated without a CDO, then with CDOA, then with CDOC, then with CDOB. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOA, CDOC n=2 Participants Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA n=2 Participants Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOC, CDOA, CDOB n=1 Participants Participants will be evaluated without a CDO, then with CDOC, then with CDOA, then with CDOB. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOC, CDOB, CDOA n=2 Participants Participants will be evaluated without a CDO, then with CDOC, then with CDOB, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Total n=22 Participants Total of all reporting groups
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	—	1 Participants n=530 Participants	—	0 Participants n=7 Participants	0 Participants n=11 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	—	—	0 Participants n=26 Participants	0 Participants n=35 Participants	1 Participants n=35 Participants	0 Participants n=32 Participants	0 Participants n=24 Participants	0 Participants n=33 Participants	2 Participants n=324 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=35 Participants	1 Participants n=4328 Participants	3 Participants n=8687 Participants	—	1 Participants n=530 Participants	—	2 Participants n=7 Participants	2 Participants n=11 Participants	1 Participants n=1 Participants	1 Participants n=2 Participants	—	—	1 Participants n=26 Participants	1 Participants n=35 Participants	1 Participants n=35 Participants	2 Participants n=32 Participants	1 Participants n=24 Participants	2 Participants n=33 Participants	20 Participants n=324 Participants
Age, Categorical <=18 years	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=269 Participants	0 Participants n=530 Participants	0 Participants n=170 Participants	0 Participants n=7 Participants	0 Participants n=11 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=32 Participants	0 Participants n=32 Participants	0 Participants n=26 Participants	0 Participants n=35 Participants	0 Participants n=35 Participants	0 Participants n=32 Participants	0 Participants n=24 Participants	0 Participants n=33 Participants	0 Participants n=324 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=35 Participants	1 Participants n=4328 Participants	3 Participants n=8687 Participants	0 Participants n=269 Participants	2 Participants n=530 Participants	0 Participants n=170 Participants	2 Participants n=7 Participants	2 Participants n=11 Participants	1 Participants n=1 Participants	1 Participants n=2 Participants	0 Participants n=32 Participants	0 Participants n=32 Participants	1 Participants n=26 Participants	1 Participants n=35 Participants	2 Participants n=35 Participants	2 Participants n=32 Participants	1 Participants n=24 Participants	2 Participants n=33 Participants	22 Participants n=324 Participants
Age, Categorical >=65 years	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	0 Participants n=269 Participants	0 Participants n=530 Participants	0 Participants n=170 Participants	0 Participants n=7 Participants	0 Participants n=11 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=32 Participants	0 Participants n=32 Participants	0 Participants n=26 Participants	0 Participants n=35 Participants	0 Participants n=35 Participants	0 Participants n=32 Participants	0 Participants n=24 Participants	0 Participants n=33 Participants	0 Participants n=324 Participants
Age, Continuous	32.0 years STANDARD_DEVIATION 0.0 • n=35 Participants	40.0 years STANDARD_DEVIATION 0.0 • n=4328 Participants	41.0 years STANDARD_DEVIATION 11.3 • n=8687 Participants	—	27.0 years STANDARD_DEVIATION 9.9 • n=530 Participants	—	35.0 years STANDARD_DEVIATION 21.2 • n=7 Participants	59.0 years STANDARD_DEVIATION 0.0 • n=11 Participants	58.0 years STANDARD_DEVIATION 0.0 • n=1 Participants	39.0 years STANDARD_DEVIATION 0.0 • n=2 Participants	—	—	56.0 years STANDARD_DEVIATION 0.0 • n=26 Participants	23.0 years STANDARD_DEVIATION 0.0 • n=35 Participants	34.5 years STANDARD_DEVIATION 3.5 • n=35 Participants	26.0 years STANDARD_DEVIATION 9.9 • n=32 Participants	29.0 years STANDARD_DEVIATION 0.0 • n=24 Participants	38.5 years STANDARD_DEVIATION 16.3 • n=33 Participants	38.5 years STANDARD_DEVIATION 13.4 • n=324 Participants
Sex: Female, Male Female	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	—	1 Participants n=530 Participants	0 Participants n=170 Participants	0 Participants n=7 Participants	1 Participants n=11 Participants	1 Participants n=1 Participants	1 Participants n=2 Participants	—	—	0 Participants n=26 Participants	0 Participants n=35 Participants	1 Participants n=35 Participants	2 Participants n=32 Participants	0 Participants n=24 Participants	2 Participants n=33 Participants	9 Participants n=324 Participants
Sex: Female, Male Male	1 Participants n=35 Participants	1 Participants n=4328 Participants	3 Participants n=8687 Participants	—	1 Participants n=530 Participants	—	2 Participants n=7 Participants	1 Participants n=11 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	—	—	1 Participants n=26 Participants	1 Participants n=35 Participants	1 Participants n=35 Participants	0 Participants n=32 Participants	1 Participants n=24 Participants	0 Participants n=33 Participants	13 Participants n=324 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	—	0 Participants n=530 Participants	—	0 Participants n=7 Participants	0 Participants n=11 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	—	—	0 Participants n=26 Participants	0 Participants n=35 Participants	0 Participants n=35 Participants	0 Participants n=32 Participants	0 Participants n=24 Participants	0 Participants n=33 Participants	0 Participants n=324 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	—	0 Participants n=530 Participants	—	0 Participants n=7 Participants	0 Participants n=11 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	—	—	0 Participants n=26 Participants	0 Participants n=35 Participants	0 Participants n=35 Participants	0 Participants n=32 Participants	0 Participants n=24 Participants	0 Participants n=33 Participants	0 Participants n=324 Participants
Race (NIH/OMB) Asian	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	—	0 Participants n=530 Participants	—	0 Participants n=7 Participants	0 Participants n=11 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	—	—	0 Participants n=26 Participants	0 Participants n=35 Participants	0 Participants n=35 Participants	0 Participants n=32 Participants	0 Participants n=24 Participants	0 Participants n=33 Participants	0 Participants n=324 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	—	0 Participants n=530 Participants	—	0 Participants n=7 Participants	0 Participants n=11 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	—	—	0 Participants n=26 Participants	0 Participants n=35 Participants	0 Participants n=35 Participants	0 Participants n=32 Participants	0 Participants n=24 Participants	0 Participants n=33 Participants	0 Participants n=324 Participants
Race (NIH/OMB) Black or African American	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	—	0 Participants n=530 Participants	—	0 Participants n=7 Participants	0 Participants n=11 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	—	—	0 Participants n=26 Participants	0 Participants n=35 Participants	0 Participants n=35 Participants	0 Participants n=32 Participants	0 Participants n=24 Participants	0 Participants n=33 Participants	0 Participants n=324 Participants
Race (NIH/OMB) White	1 Participants n=35 Participants	1 Participants n=4328 Participants	3 Participants n=8687 Participants	—	2 Participants n=530 Participants	—	1 Participants n=7 Participants	2 Participants n=11 Participants	1 Participants n=1 Participants	1 Participants n=2 Participants	—	—	1 Participants n=26 Participants	1 Participants n=35 Participants	2 Participants n=35 Participants	2 Participants n=32 Participants	1 Participants n=24 Participants	2 Participants n=33 Participants	21 Participants n=324 Participants
Race (NIH/OMB) More than one race	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	—	0 Participants n=530 Participants	—	0 Participants n=7 Participants	0 Participants n=11 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	—	—	0 Participants n=26 Participants	0 Participants n=35 Participants	0 Participants n=35 Participants	0 Participants n=32 Participants	0 Participants n=24 Participants	0 Participants n=33 Participants	0 Participants n=324 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants	0 Participants n=4328 Participants	0 Participants n=8687 Participants	—	0 Participants n=530 Participants	—	1 Participants n=7 Participants	0 Participants n=11 Participants	0 Participants n=1 Participants	0 Participants n=2 Participants	—	—	0 Participants n=26 Participants	0 Participants n=35 Participants	0 Participants n=35 Participants	0 Participants n=32 Participants	0 Participants n=24 Participants	0 Participants n=33 Participants	1 Participants n=324 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Peak joint contact stress time exposure was only calculated for participants in group 1.

Joint contact stress time exposure (MPA-s/gait cycle) was estimated using a participant specific musculoskeletal model. Peak joint contact stress time exposure (MPA-s/gait cycle) acting on the tibia during the gait cycle were reported. Lower peak contact stress time exposure is considered a better outcome.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Joint Contact Stress Time Exposure (Model Estimated)	4.25 MPa-s/gait cycle Standard Deviation 2.94	—	—	—	—	—	—	—	—	4.44 MPa-s/gait cycle Standard Deviation 2.80	3.97 MPa-s/gait cycle Standard Deviation 3.33	4.08 MPa-s/gait cycle Standard Deviation 2.96	—	—

PRIMARY outcome

Timeframe: Baseline

Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (100% of sensor) and normalized to participant body weight as they walk.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=6 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Peak Plantar Force (Total Foot)	10.4 N/kg Standard Deviation 0.7	11.0 N/kg Standard Deviation 1.3	10.5 N/kg Standard Deviation 1.0	10.6 N/kg Standard Deviation 0.8	10.2 N/kg Standard Deviation 0.7	11.0 N/kg Standard Deviation 0.9	10.3 N/kg Standard Deviation 0.9	10.5 N/kg Standard Deviation 1.2	10.6 N/kg Standard Deviation 1.0	11.3 N/kg Standard Deviation 1.2	10.5 N/kg Standard Deviation 0.8	10.7 N/kg Standard Deviation 0.7	—	—

PRIMARY outcome

Timeframe: Baseline

Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (proximal 30% of sensor) as participants walk without a CDO and with each CDO.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=7 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Peak Plantar Force (Hindfoot)	7.5 N/kg Standard Deviation 0.9	9.2 N/kg Standard Deviation 2.0	7.8 N/kg Standard Deviation 2.1	8.2 N/kg Standard Deviation 1.8	7.7 N/kg Standard Deviation 1.8	8.9 N/kg Standard Deviation 1.4	7.5 N/kg Standard Deviation 1.0	7.6 N/kg Standard Deviation 1.5	7.8 N/kg Standard Deviation 1.5	8.7 N/kg Standard Deviation 1.2	7.2 N/kg Standard Deviation 0.9	7.7 N/kg Standard Deviation 0.8	—	—

PRIMARY outcome

Timeframe: Baseline

Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (middle 30% of sensor) as participants walk without a CDO and with each CDO.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=7 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Peak Plantar Force (Midfoot)	2.9 N/kg Standard Deviation 0.5	2.5 N/kg Standard Deviation 0.9	2.0 N/kg Standard Deviation 0.7	1.6 N/kg Standard Deviation 0.2	1.7 N/kg Standard Deviation 0.4	2.1 N/kg Standard Deviation 0.5	2.2 N/kg Standard Deviation 0.7	2.3 N/kg Standard Deviation 0.6	2.3 N/kg Standard Deviation 0.6	3.0 N/kg Standard Deviation 0.7	2.8 N/kg Standard Deviation 0.9	3.1 N/kg Standard Deviation 1.3	—	—

PRIMARY outcome

Timeframe: Baseline

Plantar forces normalized to body weight (N/kg) will be measured across the forefoot (distal 40% of sensor) as participants walk without a CDO and with each CDO.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=6 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Peak Plantar Force (Forefoot)	7.7 N/kg Standard Deviation 0.9	9.0 N/kg Standard Deviation 0.6	6.9 N/kg Standard Deviation 1.5	7.1 N/kg Standard Deviation 1.9	6.4 N/kg Standard Deviation 2.3	10.3 N/kg Standard Deviation 0.9	7.8 N/kg Standard Deviation 1.8	8.0 N/kg Standard Deviation 2.0	7.9 N/kg Standard Deviation 2.0	9.7 N/kg Standard Deviation 1.0	7.7 N/kg Standard Deviation 1.3	7.7 N/kg Standard Deviation 0.9	—	—

PRIMARY outcome

Timeframe: Baseline

Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (100% of sensor) will be calculated using the integral of the force over the stance phase and normalized to participant body weight as they walk.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=6 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Plantar Force Impulse (Total Foot)	5.7 Ns/kg Standard Deviation 0.3	5.4 Ns/kg Standard Deviation 0.3	5.9 Ns/kg Standard Deviation 0.4	5.8 Ns/kg Standard Deviation 0.3	5.7 Ns/kg Standard Deviation 0.4	5.7 Ns/kg Standard Deviation 0.4	5.8 Ns/kg Standard Deviation 0.6	5.9 Ns/kg Standard Deviation 0.7	5.9 Ns/kg Standard Deviation 0.7	5.8 Ns/kg Standard Deviation 0.5	5.7 Ns/kg Standard Deviation 0.3	6.0 Ns/kg Standard Deviation 0.3	—	—

PRIMARY outcome

Timeframe: Baseline

Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (proximal 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=7 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Plantar Force Impulse (Hindfoot)	2.2 Ns/kg Standard Deviation 0.4	2.1 Ns/kg Standard Deviation 0.4	2.4 Ns/kg Standard Deviation 0.8	2.6 Ns/kg Standard Deviation 0.8	2.7 Ns/kg Standard Deviation 0.9	2.1 Ns/kg Standard Deviation 0.5	2.5 Ns/kg Standard Deviation 0.4	2.6 Ns/kg Standard Deviation 0.7	2.7 Ns/kg Standard Deviation 0.6	2.0 Ns/kg Standard Deviation 0.4	2.2 Ns/kg Standard Deviation 0.5	2.5 Ns/kg Standard Deviation 0.5	—	—

PRIMARY outcome

Timeframe: Baseline

Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (middle 30% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=7 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Plantar Force Impulse (Midfoot)	1.2 Ns/kg Standard Deviation 0.2	0.8 Ns/kg Standard Deviation 0.3	0.7 Ns/kg Standard Deviation 0.2	0.6 Ns/kg Standard Deviation 0.1	0.6 Ns/kg Standard Deviation 0.2	0.7 Ns/kg Standard Deviation 0.2	1.0 Ns/kg Standard Deviation 0.3	1.0 Ns/kg Standard Deviation 0.2	0.9 Ns/kg Standard Deviation 0.2	1.1 Ns/kg Standard Deviation 0.3	1.3 Ns/kg Standard Deviation 0.4	1.3 Ns/kg Standard Deviation 0.5	—	—

PRIMARY outcome

Timeframe: Baseline

Plantar force impulse normalized to body weight (Ns/kg) across the forefoot (distal 40% of sensor) will be calculated using the integral of the force over the stance phase as participants walk without a CDO and with each CDO.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=6 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Plantar Force Impulse (Forefoot)	2.3 Ns/kg Standard Deviation 0.1	2.5 Ns/kg Standard Deviation 0.3	2.5 Ns/kg Standard Deviation 0.6	2.6 Ns/kg Standard Deviation 0.7	2.4 Ns/kg Standard Deviation 0.8	2.8 Ns/kg Standard Deviation 0.5	2.3 Ns/kg Standard Deviation 0.5	2.3 Ns/kg Standard Deviation 0.6	2.2 Ns/kg Standard Deviation 0.6	2.7 Ns/kg Standard Deviation 0.3	2.3 Ns/kg Standard Deviation 0.2	2.2 Ns/kg Standard Deviation 0.2	—	—

PRIMARY outcome

Timeframe: Baseline

Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Lower values are better as they indicate less pain.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=6 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Numerical Pain Rating Scale (Before Performance Measures - 4SST, 5STS)	0.6 score on a scale Standard Deviation 1.1	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.6 score on a scale Standard Deviation 1.1	0.4 score on a scale Standard Deviation 0.8	0.4 score on a scale Standard Deviation 0.8	—	—

PRIMARY outcome

Timeframe: Baseline

Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable. Lower values are better as they indicate less pain

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=6 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Numerical Pain Rating Scale (After Performance Measures - 4SST, 5STS)	0.4 score on a scale Standard Deviation 0.8	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.0 score on a scale Standard Deviation 0.0	0.1 score on a scale Standard Deviation 0.3	0.0 score on a scale Standard Deviation 0.0	0.1 score on a scale Standard Deviation 0.3	0.1 score on a scale Standard Deviation 0.3	0.9 score on a scale Standard Deviation 1.2	0.4 score on a scale Standard Deviation 0.8	0.6 score on a scale Standard Deviation 1.1	—	—

PRIMARY outcome

Timeframe: Baseline

The participant will rank order their preference for their standard of care device (if applicable), No Device, CDO-A, CDO-B, CDO-C on a questionnaire.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=6 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=6 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=6 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA n=9 Participants Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA n=9 Participants Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Participant Device Preference (Rank Order NoCDO, CDOA, CDOB, CDOC)	2 Participants	1 Participants	1 Participants	1 Participants	1 Participants	1 Participants	3 Participants	3 Participants	2 Participants	1 Participants	1 Participants	1 Participants	2 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline

Participants were asked to rank order their preference for NoCDO, CDO-A, CDO-B, CDO-C on a questionnaire.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=6 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Participant Device Preference (First Preferred Condition)	3 Participants	5 Participants	0 Participants	1 Participants	0 Participants	9 Participants	0 Participants	0 Participants	0 Participants	4 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: Baseline

Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=6 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Participant Device Preference (Second Preferred Condition)	3 Participants	1 Participants	3 Participants	1 Participants	1 Participants	0 Participants	3 Participants	4 Participants	2 Participants	1 Participants	2 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: Baseline

Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=6 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Participant Device Preference (Third Preferred Condition)	1 Participants	0 Participants	3 Participants	0 Participants	3 Participants	0 Participants	2 Participants	5 Participants	2 Participants	1 Participants	2 Participants	3 Participants	—	—

PRIMARY outcome

Timeframe: Baseline

Participants were asked to rank order the testing conditions from the condition they would most prefer to walk in everyday (first preferred) to the condition they would least prefer to walk in everyday (fourth preferred).

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=6 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Participant Device Preference (Fourth Preferred Condition)	0 Participants	0 Participants	0 Participants	4 Participants	2 Participants	0 Participants	4 Participants	0 Participants	5 Participants	1 Participants	3 Participants	3 Participants	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Peak soleus muscle force was only calculate for participants in group 1.

Peak soleus muscle force (N) during gait was estimated using a participant specific musculoskeletal model.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Peak Soleus Muscle Force (Model Estimated)	1534.5 N Standard Deviation 487.5	—	—	—	—	—	—	—	—	2014.4 N Standard Deviation 408.2	1344.8 N Standard Deviation 754.0	1529.6 N Standard Deviation 479.3	—	—

SECONDARY outcome

Timeframe: Baseline

Population: Peak gastrocnemius muscle force was only calculated for participants in group 1.

Peak gastrocnemius muscle force (N) during gait was estimated using a participant specific musculoskeletal model.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Peak Gastrocnemius Muscle Force (Model Estimated)	1593.4 N Standard Deviation 426.9	—	—	—	—	—	—	—	—	1670.3 N Standard Deviation 328.6	1425.4 N Standard Deviation 559.1	1568.0 N Standard Deviation 464.3	—	—

SECONDARY outcome

Timeframe: Baseline

Peak ankle dorsiflexion (degrees) during gait.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=7 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Ankle Range of Motion	13.6 degree Standard Deviation 1.8	16.3 degree Standard Deviation 2.5	12.3 degree Standard Deviation 1.4	12.3 degree Standard Deviation 1.4	12.4 degree Standard Deviation 1.3	17.1 degree Standard Deviation 3.2	13.4 degree Standard Deviation 2.5	12.8 degree Standard Deviation 2.6	12.6 degree Standard Deviation 2.4	17.0 degree Standard Deviation 2.5	13.3 degree Standard Deviation 1.9	12.9 degree Standard Deviation 1.6	—	—

SECONDARY outcome

Timeframe: Baseline

Peak ankle plantarflexion moment (Nm/kg) during gait.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=7 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Peak Ankle Moment	1.5 Nm/kg Standard Deviation 0.2	1.4 Nm/kg Standard Deviation 0.1	1.5 Nm/kg Standard Deviation 0.1	1.5 Nm/kg Standard Deviation 0.1	1.5 Nm/kg Standard Deviation 0.1	1.4 Nm/kg Standard Deviation 0.2	1.4 Nm/kg Standard Deviation 0.2	1.4 Nm/kg Standard Deviation 0.2	1.4 Nm/kg Standard Deviation 0.2	1.5 Nm/kg Standard Deviation 0.1	1.5 Nm/kg Standard Deviation 0.1	1.5 Nm/kg Standard Deviation 0.1	—	—

SECONDARY outcome

Timeframe: Baseline

Peak ankle push-off power (W/kg) during gait.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=7 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=7 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Peak Ankle Power	1.6 W/kg Standard Deviation 0.6	2.6 W/kg Standard Deviation 0.7	1.4 W/kg Standard Deviation 0.1	1.4 W/kg Standard Deviation 0.2	1.2 W/kg Standard Deviation 0.2	3.5 W/kg Standard Deviation 0.6	1.5 W/kg Standard Deviation 0.4	1.5 W/kg Standard Deviation 0.4	1.5 W/kg Standard Deviation 0.4	3.0 W/kg Standard Deviation 0.8	1.2 W/kg Standard Deviation 0.4	1.4 W/kg Standard Deviation 0.5	—	—

SECONDARY outcome

Timeframe: Baseline

The 4SST (s) is a standardized timed test of balance and agility. One inch pipe is placed on the floor in the shape of a Maltese cross and participants are instructed to begin in the back left quadrant then to move 1) forward, 2) sideways right, 3) backward, then 4) sideways left, then to move in the reverse direction back to the original square.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=6 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Four Square Step Test (4SST)	6.3 seconds Standard Deviation 1.4	7.1 seconds Standard Deviation 2.9	6.7 seconds Standard Deviation 2.0	7.2 seconds Standard Deviation 2.4	7.0 seconds Standard Deviation 2.2	6.1 seconds Standard Deviation 0.9	6.3 seconds Standard Deviation 1.1	6.4 seconds Standard Deviation 1.0	6.5 seconds Standard Deviation 1.1	6.6 seconds Standard Deviation 1.7	6.6 seconds Standard Deviation 1.5	6.5 seconds Standard Deviation 1.5	—	—

SECONDARY outcome

Timeframe: Baseline

STS5 (s) is a well-established timed measure of lower limb muscle strength and power. Participants are instructed to start the test sitting with their arms folded across their chest and with their back against a standard chair. Patients are then instructed to stand up and sit down 5 times as fast as possible, avoiding touching their back to the chair during each repetition. The time to complete all five continuous repetitions is reported.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=6 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Sit to Stand 5 Times (STS5)	8.4 seconds Standard Deviation 2.4	7.3 seconds Standard Deviation 1.5	8.9 seconds Standard Deviation 1.7	9.7 seconds Standard Deviation 2.4	8.8 seconds Standard Deviation 1.5	7.0 seconds Standard Deviation 1.3	7.5 seconds Standard Deviation 1.5	7.7 seconds Standard Deviation 1.8	7.8 seconds Standard Deviation 1.6	7.9 seconds Standard Deviation 2.3	8.8 seconds Standard Deviation 2.7	8.6 seconds Standard Deviation 2.5	—	—

SECONDARY outcome

Timeframe: Baseline

Satisfaction with device will be assessed using the Orthotics Prosthetics Users' Survey Satisfaction With Device Score (11-55). Lower scores indicate a better outcome.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=9 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
The Orthotics Prosthetics Users' Survey (OPUS)	23.3 score on a scale Standard Deviation 12.6	23.8 score on a scale Standard Deviation 13.4	36.3 score on a scale Standard Deviation 3.4	26.0 score on a scale Standard Deviation 14.7	37.8 score on a scale Standard Deviation 4.0	36.6 score on a scale Standard Deviation 4.0	—	—	—	29.0 score on a scale Standard Deviation 10.9	30.3 score on a scale Standard Deviation 8.1	31.7 score on a scale Standard Deviation 9.7	—	—

SECONDARY outcome

Timeframe: Baseline

Comfort scores range from 0 = most uncomfortable to 10 = most comfortable. Higher scores are better as they indicate a more comfortable device.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=9 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Modified Socket Comfort Score (Comfort)	7.0 score on a scale Standard Deviation 1.3	7.0 score on a scale Standard Deviation 1.4	7.4 score on a scale Standard Deviation 2.2	7.7 score on a scale Standard Deviation 0.8	7.1 score on a scale Standard Deviation 2.6	6.7 score on a scale Standard Deviation 2.2	—	—	—	6.3 score on a scale Standard Deviation 1.8	6.4 score on a scale Standard Deviation 2.0	7.6 score on a scale Standard Deviation 1.3	—	—

SECONDARY outcome

Timeframe: Baseline

Comfort scores range from 0 = least smooth to 10 = most smooth. Higher scores are better as they indicate a smoother rollover with the device.

Outcome measures

Outcome measures
Measure	Group 1: CDOC n=6 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 2: NoCDO n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: CDOB n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 2: CDOA n=6 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 2: CDOB n=9 Participants In Group 2 the design of the CDO proximal cuff was tested with CDOA using a cuff secured with a Chicago screw and Velcro, CDOB using a cuff secured with a ratcheting system (BOA Dial), and CDOC using a cuff consisting of a posterior and an anterior section secured with Velcro.	Group 3: NoCDO n=9 Participants In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOA In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOB In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: CDOC In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 1: NoCDO n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOA n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 1: CDOB n=7 Participants In Group 1 CDO stiffness was tested with CDOA being the stiffest (7.0(2.1)Nm/deg, CDOB being the moderate stiffness 5.4(1.4)Nm/deg, and CDOC being the least stiff 3.9(1.2)Nm/deg	Group 3: NoCDO, CDOC, CDOB, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOA, then with CDOC. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.	Group 3: NoCDO, CDOB, CDOC, CDOA Participants will be evaluated without a CDO, then with CDOB, then with CDOC, then with CDOA. Carbon Fiber Custom Dynamic Orthosis (CDO): The CDO will consist of a full length foot plate, a posterior carbon fiber strut, and a proximal cuff that wraps around the leg just below the knee. In Group 3 the tightness of the CDO proximal cuff was tested with CDOA testing occurring with the cuff tightened to 30N, CDOB testing occurring with the cuff tightened to 50N, and CDOC testing occurring with the cuff tightened to 70N.
Modified Socket Comfort Score (Smoothness)	6.5 score on a scale Standard Deviation 2.1	6.8 score on a scale Standard Deviation 0.8	7.6 score on a scale Standard Deviation 1.8	7.7 score on a scale Standard Deviation 1.4	7.7 score on a scale Standard Deviation 1.9	7.1 score on a scale Standard Deviation 1.9	—	—	—	6.1 score on a scale Standard Deviation 1.6	5.7 score on a scale Standard Deviation 2.1	7.7 score on a scale Standard Deviation 2.0	—	—

Other adverse events

Adverse event data not reported

Additional Information

Jason M. Wilken, PT, PhD

The University of Iowa

Phone: 319-335-6857

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place