Trial Outcomes & Findings for Evaluating Mobility Interventions in the Real World (NCT NCT04275973)

Results Overview

Minimum Foot Clearance with different prostheses, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Results posted on

2025-12-19

Participant Flow

Healthy control participants were not consented or enrolled.

Participant milestones

Participant milestones
Measure	Prosthesis User With Transtibial or Transfemoral Amputation Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Lower limb prostheses: Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA).	Orthoses User With Drop-foot This arm will consists of participants with drop-foot. All of the drop-foot population were persons with Multiple Sclerosis. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Orthoses for Drop-foot: Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses.
Overall Study STARTED	8	12
Overall Study Low Profile Foot	5	0
Overall Study Energy Storage and Return Foot	5	0
Overall Study Passive Hydraulic Ankle	5	0
Overall Study Microprocessor Hydraulic Ankle	2	0
Overall Study No Intervention	0	11
Overall Study Ankle Foot Orthosis (AFO)	0	11
Overall Study Functional Electrical Stimulation (FES) Device	0	11
Overall Study COMPLETED	6	11
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Prosthesis User With Transtibial or Transfemoral Amputation Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Lower limb prostheses: Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA).	Orthoses User With Drop-foot This arm will consists of participants with drop-foot. All of the drop-foot population were persons with Multiple Sclerosis. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Orthoses for Drop-foot: Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses.
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Evaluating Mobility Interventions in the Real World

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Population: All participants did not complete tests with all prostheses.

Minimum Foot Clearance with different prostheses, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.

Outcome measures

Outcome measures
Measure	Prosthesis User With Transtibial or Transfemoral Amputation n=6 Participants Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Lower limb prostheses: Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA).	Orthoses User With Drop-foot This arm will consists of participants with drop-foot. All of the drop-foot population were persons with Multiple Sclerosis. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Orthoses for Drop-foot: Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses.
Minimum Foot Clearance With Different Prostheses Low Profile Foot	0.02117 meters Standard Deviation 0.005247	—
Minimum Foot Clearance With Different Prostheses Energy Storage and Return Foot	0.01976 meters Standard Deviation 0.007828	—
Minimum Foot Clearance With Different Prostheses Passive Hydraulic Ankle	0.01932 meters Standard Deviation 0.004138	—
Minimum Foot Clearance With Different Prostheses Microprocessor Hydraulic Ankle	0.03055 meters Standard Deviation 0.001360	—

PRIMARY outcome

Timeframe: Baseline, 10 days, and 20 days for Orthotic interventions

Population: 1 participant could not be assessed for this measure

Minimum Foot Clearance with different orthoses, participants crossover to each of 3 different conditions at different study visits, data collected up to 20 days on study.

Outcome measures

Outcome measures
Measure	Prosthesis User With Transtibial or Transfemoral Amputation n=10 Participants Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Lower limb prostheses: Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA).	Orthoses User With Drop-foot This arm will consists of participants with drop-foot. All of the drop-foot population were persons with Multiple Sclerosis. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Orthoses for Drop-foot: Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses.
Minimum Foot Clearance With Different Orthoses Ankle Foot Orthosis	0.721081 centimeters Standard Deviation 0.857378	—
Minimum Foot Clearance With Different Orthoses Functional Electrical Stimulation Device	0.81136 centimeters Standard Deviation 1.105746	—
Minimum Foot Clearance With Different Orthoses No Intervention	0.56469 centimeters Standard Deviation 0.662561	—

SECONDARY outcome

Timeframe: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Population: All participants did not complete tests with all prostheses.

Behavioral gait function will be measured by daily stride count (strides per sensor hour, Prosthetics only), participants crossed over to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.

Outcome measures

Outcome measures
Measure	Prosthesis User With Transtibial or Transfemoral Amputation n=6 Participants Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Lower limb prostheses: Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA).	Orthoses User With Drop-foot This arm will consists of participants with drop-foot. All of the drop-foot population were persons with Multiple Sclerosis. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Orthoses for Drop-foot: Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses.
Behavioral Gait Function as Measured From Daily Stride Count Low Profile Foot	264.9 strides per sensor hour Standard Deviation 177.0	—
Behavioral Gait Function as Measured From Daily Stride Count Energy Storage and Return Foot	245.7 strides per sensor hour Standard Deviation 113.1	—
Behavioral Gait Function as Measured From Daily Stride Count Passive Hydraulic Ankle	230.9 strides per sensor hour Standard Deviation 117.8	—
Behavioral Gait Function as Measured From Daily Stride Count Microprocessor Hydraulic Ankle	269.3 strides per sensor hour Standard Deviation 92.49	—

SECONDARY outcome

Timeframe: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Population: Participants had varying ability to walk at different speeds.

Behavioral gait function will be measured by average stride speed, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.

Outcome measures

Outcome measures
Measure	Prosthesis User With Transtibial or Transfemoral Amputation n=6 Participants Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Lower limb prostheses: Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA).	Orthoses User With Drop-foot This arm will consists of participants with drop-foot. All of the drop-foot population were persons with Multiple Sclerosis. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Orthoses for Drop-foot: Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses.
Behavioral Gait Function as Measured From Stride Speed During Walking Bouts of Different Durations less than 10 seconds	0.4685 meters per second Standard Deviation 0.049	—
Behavioral Gait Function as Measured From Stride Speed During Walking Bouts of Different Durations 10 to 30 seconds	0.7155 meters per second Standard Deviation 0.0936	—
Behavioral Gait Function as Measured From Stride Speed During Walking Bouts of Different Durations 30-60 seconds	0.906 meters per second Standard Deviation 0.1172	—
Behavioral Gait Function as Measured From Stride Speed During Walking Bouts of Different Durations 60-120 seconds	0.9652 meters per second Standard Deviation 0.1562	—
Behavioral Gait Function as Measured From Stride Speed During Walking Bouts of Different Durations greater than 120 seconds	1.0486 meters per second Standard Deviation 0.1979	—

SECONDARY outcome

Timeframe: up to 12 weeks

Population: All participants did not complete tests with all prostheses.

The Prosthetic Limb Users Survey of Mobility (PLUS-M) is a 12 item questionnaire. It is a self-report instrument for measuring mobility of adults with lower limb amputation. PLUS-M instruments measure prosthetic users' mobility (i.e., the ability to move intentionally and independently from one place to another). PLUS-M questions assess respondents' perceived ability to carry out actions that require use of both lower limbs, ranging from household ambulation to outdoor recreational activities. The described activities relate to two primary forms of movement, locomotion (i.e., movement in a continuous, repeatable pattern) and/or postural transitions (i.e., movement from one position to another or one type of activity to another). PLUS-M instruments provide a T-score that averages 50 with a standard deviation of 10. A higher PLUS-M T-score corresponds to greater mobility.

Outcome measures

Outcome measures
Measure	Prosthesis User With Transtibial or Transfemoral Amputation n=6 Participants Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Lower limb prostheses: Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA).	Orthoses User With Drop-foot This arm will consists of participants with drop-foot. All of the drop-foot population were persons with Multiple Sclerosis. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Orthoses for Drop-foot: Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses.
Prosthetic Limb Users Survey of Mobility Score Low Profile Foot	56.5 T-score Standard Deviation 7.665246245	—
Prosthetic Limb Users Survey of Mobility Score Energy Storage and Return Foot	53.78 T-score Standard Deviation 7.3123	—
Prosthetic Limb Users Survey of Mobility Score Passive Hydraulic Ankle	53.83 T-score Standard Deviation 7.898	—
Prosthetic Limb Users Survey of Mobility Score Microprocessor Hydraulic Ankle	47.4 T-score Standard Deviation 5.444	—

SECONDARY outcome

Timeframe: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Population: All participants did not complete tests with all prostheses.

Change in movement quality will be determined by stride width, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study. Stride width is the absolute value of the lateral distance from a line that is fit to the foot placements of 3 strides previous and 3 strides after the current stride, to the foot placement location of the current stride.

Outcome measures

Outcome measures
Measure	Prosthesis User With Transtibial or Transfemoral Amputation n=6 Participants Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Lower limb prostheses: Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA).	Orthoses User With Drop-foot This arm will consists of participants with drop-foot. All of the drop-foot population were persons with Multiple Sclerosis. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Orthoses for Drop-foot: Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses.
Change in Movement Quality as Determined by Stride Width: Prosthesis Low Profile Foot	0.1328 meters Standard Deviation 0.03138	—
Change in Movement Quality as Determined by Stride Width: Prosthesis Energy Storage and Return Foot	0.1417 meters Standard Deviation 0.05243	—
Change in Movement Quality as Determined by Stride Width: Prosthesis Passive Hydraulic Ankle	0.11526455 meters Standard Deviation 0.02398894	—
Change in Movement Quality as Determined by Stride Width: Prosthesis Microprocessor Hydraulic Ankle	0.1202 meters Standard Deviation 0.04510	—

SECONDARY outcome

Timeframe: Baseline, 10 days, and 20 days for Orthotic interventions

Population: Sensor did not work for one participant during the AFO condition.

Change in movement quality will be determined by stride width, participants crossover to different conditions at different study visits, data collected up to 20 days on study. Stride width is the absolute value of the lateral distance from a line that is fit to the foot placements of 3 strides previous and 3 strides after the current stride, to the foot placement location of the current stride.

Outcome measures

Outcome measures
Measure	Prosthesis User With Transtibial or Transfemoral Amputation n=11 Participants Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Lower limb prostheses: Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA).	Orthoses User With Drop-foot This arm will consists of participants with drop-foot. All of the drop-foot population were persons with Multiple Sclerosis. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Orthoses for Drop-foot: Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses.
Change in Movement Quality as Determined by Stride Width: Orthoses No Intervention	0.045 meters Standard Deviation 0.010	—
Change in Movement Quality as Determined by Stride Width: Orthoses AFO: Sprystep	0.045 meters Standard Deviation 0.010	—
Change in Movement Quality as Determined by Stride Width: Orthoses FES: Bioness	0.047 meters Standard Deviation 0.014	—

SECONDARY outcome

Timeframe: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Population: All participants did not complete tests with all prostheses.

Change in gait performance as determined by speed of the participant, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.

Outcome measures

Outcome measures
Measure	Prosthesis User With Transtibial or Transfemoral Amputation n=6 Participants Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Lower limb prostheses: Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA).	Orthoses User With Drop-foot This arm will consists of participants with drop-foot. All of the drop-foot population were persons with Multiple Sclerosis. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Orthoses for Drop-foot: Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses.
Change in Gait Performance as Determined by Average Speed Low Profile Foot	0.8376 meter per second Standard Deviation 0.1332	—
Change in Gait Performance as Determined by Average Speed Energy Storage and Return Foot	0.8553 meter per second Standard Deviation 0.1149	—
Change in Gait Performance as Determined by Average Speed Passive Hydraulic Ankle	0.8635 meter per second Standard Deviation 0.1444	—
Change in Gait Performance as Determined by Average Speed Microprocessor Hydraulic Ankle	0.9521 meter per second Standard Deviation 0.08561	—

SECONDARY outcome

Timeframe: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Population: All participants did not complete tests with all prostheses.

Gait performance as determined by stride frequency at identical speed (included strides with walking speeds between 0.75-1.25 meters per second). Participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.

Outcome measures

Outcome measures
Measure	Prosthesis User With Transtibial or Transfemoral Amputation n=6 Participants Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Lower limb prostheses: Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA).	Orthoses User With Drop-foot This arm will consists of participants with drop-foot. All of the drop-foot population were persons with Multiple Sclerosis. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Orthoses for Drop-foot: Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses.
Gait Performance as Determined by Stride Frequency at Identical Speed Low Profile Foot	67.47 strides per minute Standard Deviation 3.237	—
Gait Performance as Determined by Stride Frequency at Identical Speed Energy Storage and Return Foot	68.22 strides per minute Standard Deviation 5.835	—
Gait Performance as Determined by Stride Frequency at Identical Speed Passive Hydraulic Ankle	67.46 strides per minute Standard Deviation 4.130	—
Gait Performance as Determined by Stride Frequency at Identical Speed Microprocessor Hydraulic Ankle	60.37 strides per minute Standard Deviation 5.448	—

SECONDARY outcome

Timeframe: Baseline, 10 days, and 20 days for Orthotic interventions, weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Population: No data was collected because the force and torque sensor could not be fit into the leg.

Ground reaction force is force applied by the body to the ground. Peak forces and shape of the force vs. time trajectory are commonly used to assess gait quality. Forces closer to "normal" are usually considered better, but this goal does not apply in participants with amputation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 10 days, and 20 days for Orthotic interventions, weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Population: No data collected because the force and torque sensor could not be fit into the leg.

Socket torque (also termed "socket moment") is the amount of twisting or bending torque applied to the prosthetic socket. Peak socket torque and cumulative socket torque are measures commonly used to assess gait quality in persons with lower limb amputation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 10 days, and 20 days for Orthotic interventions

The Functional Gait Assessment Score will be measured for the sub-population of participants with Multiple Sclerosis (MS). The total score ranges from 0-30 with higher scores indicating increased impairment in gait. Participants crossover to each of three conditions at different study visits.

Outcome measures

Outcome measures
Measure	Prosthesis User With Transtibial or Transfemoral Amputation n=11 Participants Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Lower limb prostheses: Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA).	Orthoses User With Drop-foot This arm will consists of participants with drop-foot. All of the drop-foot population were persons with Multiple Sclerosis. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Orthoses for Drop-foot: Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses.
Change in Functional Gait Assessment Score No Intervention	16.09 score on a scale Standard Deviation 5.230	—
Change in Functional Gait Assessment Score Ankle Foot Orthosis	17.27 score on a scale Standard Deviation 6.566	—
Change in Functional Gait Assessment Score Functional Electrical Stimulation Device	18.45 score on a scale Standard Deviation 5.298	—

SECONDARY outcome

Timeframe: Baseline, 10 days, and 20 days study visits to test conditions for Orthotic interventions

The sub-population of participants with MS will undergo a 6 minute walking test for distance. Each participant will crossover to three conditions over three study visits: No intervention, the carbon fiber ankle foot orthosis (cfAFO), and a functional electrical stimulation (FES) device). Reported here are the difference from No intervention for the cfAFO and FES orthoses, a positive number shows an increase in distance walked due to the intervention.

Outcome measures

Outcome measures
Measure	Prosthesis User With Transtibial or Transfemoral Amputation n=11 Participants Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Lower limb prostheses: Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA).	Orthoses User With Drop-foot This arm will consists of participants with drop-foot. All of the drop-foot population were persons with Multiple Sclerosis. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Orthoses for Drop-foot: Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses.
Change in 6 Minute Walking Test Distance No Intervention	394.94 meters Standard Deviation 123.83	—
Change in 6 Minute Walking Test Distance AFO: Sprystep	426.73 meters Standard Deviation 117.87	—
Change in 6 Minute Walking Test Distance FES: Bioness	419.09 meters Standard Deviation 127.16	—

SECONDARY outcome

Timeframe: Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

Population: All participants did not complete tests with all prostheses.

Walking speeds from 0.75 to 1.25 meters per second were analyzed, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.

Outcome measures

Outcome measures
Measure	Prosthesis User With Transtibial or Transfemoral Amputation n=6 Participants Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Lower limb prostheses: Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA).	Orthoses User With Drop-foot This arm will consists of participants with drop-foot. All of the drop-foot population were persons with Multiple Sclerosis. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Orthoses for Drop-foot: Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses.
Stride Length at Identical Walking Speed Energy Storage and Return Foot	1.198 meters Standard Deviation 0.09409	—
Stride Length at Identical Walking Speed Passive Hydraulic Ankle	1.200 meters Standard Deviation 0.1564	—
Stride Length at Identical Walking Speed Microprocessor Hydraulic Ankle	1.302 meters Standard Deviation 0.1194	—
Stride Length at Identical Walking Speed Low Profile Foot	1.196 meters Standard Deviation 0.1434	—

Adverse Events

Prosthesis User With Transtibial or Transfemoral Amputation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Orthoses User With Drop-foot

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Peter Adamczyk

University of Wisconsin - Madison

Phone: (608) 263-3231

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Prosthesis User With Transtibial or Transfemoral Amputation n=6 Participants Experiments will use standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA). Lower limb prostheses: Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA).	Orthoses User With Drop-foot n=11 Participants This arm will consists of participants with drop-foot. All of the drop-foot population were persons with Multiple Sclerosis. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses. Orthoses for Drop-foot: Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses.	Total n=17 Participants Total of all reporting groups
Age, Continuous	57 years n=8 Participants	43 years n=6 Participants	48 years n=6 Participants
Sex: Female, Male Female	3 Participants n=8 Participants	7 Participants n=6 Participants	10 Participants n=6 Participants
Sex: Female, Male Male	3 Participants n=8 Participants	4 Participants n=6 Participants	7 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=8 Participants	11 Participants n=6 Participants	17 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) White	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=8 Participants	11 Participants n=6 Participants	17 Participants n=6 Participants
Region of Enrollment United States	6 participants n=8 Participants	11 participants n=6 Participants	17 participants n=6 Participants
Participants Diagnosed with Multiple Sclerosis (MS)	0 Participants n=8 Participants	11 Participants n=6 Participants	11 Participants n=6 Participants