Comparing Intact and Residual Amputated Muscle
1 other identifier
interventional
80
1 country
1
Brief Summary
Lower limb amputees rely on their prosthetic to remain active and lead an independent life. In recent years, measuring residual muscle activity has been used to interpret a user's intent and thereby modulate prosthesis control. However, little knowledge is held on how residual muscle activity differs from non-amputated muscle. The research team will analyze and compare neuromuscular physiology in non-amputee individuals and amputees' non-amputated and residual muscles across functional tasks to better understand how amputees control their muscles. Such information will inform design of modern prosthesis controllers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 17, 2022
CompletedFirst Submitted
Initial submission to the registry
July 8, 2022
CompletedFirst Posted
Study publicly available on registry
December 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2025
CompletedDecember 26, 2023
December 1, 2023
2.5 years
July 8, 2022
December 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Motor Unit Action Potential Amplitudes
The investigators will measure muscle activity via electromyography on the individuals' muscles controlling their ankle joint (note for residual muscle they are controlling their phantom limb). Properties of motor units will be gathered from surface electromyography (EMG) decomposed into individual motor unit firings. These properties will be compared between intact and residual muscle.
Through study completion (an average of 36 months).
Motor Unit Coherence
The investigators will measure muscle activity via electromyography on the individuals' muscles controlling their ankle joint (note for residual muscle they are controlling their phantom limb). Properties of motor units will be gathered from surface electromyography (EMG) decomposed into individual motor unit firings. These properties will be compared between intact and residual muscle.
Through study completion (an average of 36 months).
Secondary Outcomes (1)
Muscle Architecture Properties -- Muscle Volume
Through study completion (an average of 36 months).
Study Arms (2)
Individuals Without Amputation
NO INTERVENTIONNo Intervention Tested in identical tasks for comparison to Individuals with Amputation
Individuals With Amputation
EXPERIMENTALTasks with a passive prosthesis Tasks with a powered active prosthesis
Interventions
Custom in-house powered prosthetic device (used in prior studies, see Citations).
Eligibility Criteria
You may qualify if:
- Live in the United States
- Are 18 years of age or older
- Can walk across low-level environmental barriers such as curbs, stairs, or uneven surfaces unassisted and without much difficulty
You may not qualify if:
- \- Have any cognitive, visual, or balance impairments that affects your ability to provide informed consent or to follow instructions during the experiments
- Have had a stroke
- Have heart disease
- Weigh 450 pounds or more (for harness safety)
- Have a girth/waist circumference more than 49 inches (124.4 cm) (for harness safety)
- Have allergies to adhesives
- Live in the United States
- Are a unilateral lower-limb amputee
- Have lower limb length from the knee to where the amputation occurred at least 10cm long
- Can walk across low-level environmental barriers such as curbs, stairs, or uneven surfaces unassisted and without much difficulty
- \- Have any cognitive, visual, or balance impairments that affects your ability to provide consent or to follow instructions during the experiments
- Have had a stroke
- Have heart disease
- Had skin lesions/incomplete healing following amputation
- Have ulcers
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
North Carolina State University
Raleigh, North Carolina, 27695, United States
Related Publications (1)
Huang S, Wensman JP, Ferris DP. Locomotor Adaptation by Transtibial Amputees Walking With an Experimental Powered Prosthesis Under Continuous Myoelectric Control. IEEE Trans Neural Syst Rehabil Eng. 2016 May;24(5):573-81. doi: 10.1109/TNSRE.2015.2441061. Epub 2015 Jun 4.
PMID: 26057851BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Jackson Family Distinguished Professor
Study Record Dates
First Submitted
July 8, 2022
First Posted
December 26, 2023
Study Start
June 17, 2022
Primary Completion
December 31, 2024
Study Completion
May 31, 2025
Last Updated
December 26, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share