Trial Outcomes & Findings for Upper Limb Loss Perturbation Response (NCT NCT04274218)

Last Updated: 2024-11-14

Results Overview

Whole-body angular momentum is the momentum of all limb segments about the Body Center of Mass (BCoM) summed. Whole-body angular momentum is estimated in the sagittal plane, which is the plane of walking progression, and the range of this value is normalized to a person's body mass, height, and walking speed. Whole body angular momentum is minimized by the central nervous system to facilitate postural control. For this study, whole body angular momentum range was averaged across the 12 perturbation trials and then across all participants. To note, the reported whole body angular momentum values are the relative increase from baseline to perturbation recovery that are all measured in the same session. There are no additional sessions as the baseline whole body angular momentum reflects those values before the perturbation trials.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

1 hour

Results posted on

2024-11-14

Participant Flow

10 participants with upper limb absence and 10 healthy controls were screened for eligibility between December 1 2020 and February 10 2022. Individuals with upper limb loss were recruited from clinics providing prosthetics care and education programs for prosthetics. Healthy controls were recruited from the Chicago community.

All 20 participants agreed to participate and completed the study protocol.

Participant milestones

Participant milestones
Measure	Healthy Controls - Arms Free Then One Arm Bound Healthy controls without limb loss provided demographic information, then completed baseline walking for 1 minute, and then received a treadmill belt disturbance while walking under two conditions in a cross-over study design. Healthy controls either walked with both arms free first, then with one arm bound, OR with one arm bound first, then with both arms free. The order of arms free and bound conditions were randomized. There is no washout period and each condition lasted for 15 minutes.	Upper Limb Absence - With Prosthesis First Then w/o Prosthesis Individuals with upper limb loss between the wrist and elbow provided demographic information, then completed baseline walking for 1 minute, and then received a treadmill belt disturbance while walking while walking under two conditions in a cross-over study design. Individuals with upper limb loss walked either with their prosthesis first, then without their prosthesis, OR without their prosthesis first, then with their prosthesis. The order of with and without prosthesis conditions were randomized. There is no washout period and each condition lasted for 15 minutes.	Healthy Controls - One Arm Bound Then Both Arms Free Healthy controls without limb loss provided demographic information, then completed baseline walking for 1 minute, and then received a treadmill belt disturbance while walking under two conditions in a cross-over study design. Healthy controls either walked with both arms free first, then with one arm bound, OR with one arm bound first, then with both arms free. The order of arms free and bound conditions were randomized. There is no washout period and each condition lasted for 15 minutes.	Upper Limb Absenece - w/o Prosthesis First Then With Prosthesis Individuals with upper limb loss between the wrist and elbow provided demographic information, then completed baseline walking for 1 minute, and then received a treadmill belt disturbance while walking while walking under two conditions in a cross-over study design. Individuals with upper limb loss walked either with their prosthesis first, then without their prosthesis, OR without their prosthesis first, then with their prosthesis. The order of with and without prosthesis conditions were randomized. There is no washout period and each condition lasted for 15 minutes.
Demographic Information (10 Minutes) STARTED	5	6	5	4
Demographic Information (10 Minutes) COMPLETED	5	6	5	4
Demographic Information (10 Minutes) NOT COMPLETED	0	0	0	0
Baseline Walking (1 Minute) STARTED	5	6	5	4
Baseline Walking (1 Minute) COMPLETED	5	6	5	4
Baseline Walking (1 Minute) NOT COMPLETED	0	0	0	0
Perturbation Condition 1 (15 Minutes) STARTED	5	6	5	4
Perturbation Condition 1 (15 Minutes) COMPLETED	5	6	5	4
Perturbation Condition 1 (15 Minutes) NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Upper Limb Loss Perturbation Response

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Controls n=10 Participants Healthy controls without limb loss will receive a treadmill belt disturbance while walking. Able-bodied individuals will walk with both arms free and with one arm bound.	Upper Limb Absence n=10 Participants Individuals with upper limb loss between the wrist and elbow will receive a treadmill belt disturbance while walking with and without their prosthesis.	Total n=20 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 16 • n=5 Participants	44 years STANDARD_DEVIATION 15 • n=7 Participants	44 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: Data collected for each participant during baseline and when recovering from the perturbation.

Outcome measures

Outcome measures
Measure	Healthy Controls Arms Free n=10 Participants Healthy controls with both arms free to move.	Upper Limb Absence Without Prosthesis n=10 Participants Individuals with upper limb absence not wearing their prosthesis.	Healthy Controls One Arm Bound n=10 Participants Healthy controls with the non-dominant arm bound to the body.	Upper Limb Absence With Prosthesis n=10 Participants Individuals with upper limb absence wearing their prosthesis.
Whole-body Angular Momentum in Sagittal-plane; Momentum of the Body in the Sagittal Plane of Walking Progression	0.025 Unitless (normalized) Standard Deviation 0.0006	0.031 Unitless (normalized) Standard Deviation 0.006	0.027 Unitless (normalized) Standard Deviation 0.009	0.028 Unitless (normalized) Standard Deviation 0.006

SECONDARY outcome

Timeframe: 1 hour

Population: Range of motion of shoulder flexion-extension of the impaired (individuals with upper limb absence) or non-dominant arm (healthy controls) during perturbation recovery.

Range-of-motion for shoulder joint angle flexion-extension of the impaired or non-dominant arm (Deg) during perturbation recovery; Dynamics used for postural control to regulate and reduce whole-body angular momentum during trip response.

Outcome measures

Outcome measures
Measure	Healthy Controls Arms Free n=10 Participants Healthy controls with both arms free to move.	Upper Limb Absence Without Prosthesis n=10 Participants Individuals with upper limb absence not wearing their prosthesis.	Healthy Controls One Arm Bound n=10 Participants Healthy controls with the non-dominant arm bound to the body.	Upper Limb Absence With Prosthesis n=10 Participants Individuals with upper limb absence wearing their prosthesis.
Shoulder Angle Flexion-extension Range	36 Degrees Standard Deviation 18	34 Degrees Standard Deviation 10	5 Degrees Standard Deviation 1	31 Degrees Standard Deviation 16

SECONDARY outcome

Timeframe: 1 hour

Population: Controls with both arms free or one arm bound and persons with upper limb absence wearing or not wearing their prosthesis.

Maximum flexion angle (degrees) of the trunk during perturbation recovery.

Outcome measures

Outcome measures
Measure	Healthy Controls Arms Free n=10 Participants Healthy controls with both arms free to move.	Upper Limb Absence Without Prosthesis n=10 Participants Individuals with upper limb absence not wearing their prosthesis.	Healthy Controls One Arm Bound n=10 Participants Healthy controls with the non-dominant arm bound to the body.	Upper Limb Absence With Prosthesis n=10 Participants Individuals with upper limb absence wearing their prosthesis.
Trunk Flexion Angle	9.9 Degrees Standard Deviation 3.1	10.1 Degrees Standard Deviation 2.7	10.1 Degrees Standard Deviation 4.1	10.2 Degrees Standard Deviation 2.7

SECONDARY outcome

Timeframe: 1 hour

Population: Controls with both arms free or one arm bound and persons with upper limb absence with or without their prosthesis.

Maximum trunk flexion velocity (deg/s) during perturbation recovery

Outcome measures

Outcome measures
Measure	Healthy Controls Arms Free n=10 Participants Healthy controls with both arms free to move.	Upper Limb Absence Without Prosthesis n=10 Participants Individuals with upper limb absence not wearing their prosthesis.	Healthy Controls One Arm Bound n=10 Participants Healthy controls with the non-dominant arm bound to the body.	Upper Limb Absence With Prosthesis n=10 Participants Individuals with upper limb absence wearing their prosthesis.
Trunk Flexion Velocity	35.2 Degrees/second Standard Deviation 6.3	34.5 Degrees/second Standard Deviation 9.3	37.2 Degrees/second Standard Deviation 9.4	32.9 Degrees/second Standard Deviation 10.8

Adverse Events

Healthy Controls With Arms Free

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Upper Limb Absence Without Prosthesis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Controls With One Arm Bound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Upper Limb Absence With Prosthesis

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

Matthew Major

US Department of Veterans Affairs

Phone: 3125035731

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place