Status:
UNKNOWN
Comparing Intact and Residual Amputated Muscle
Lead Sponsor:
North Carolina State University
Conditions:
Amputation
Eligibility:
All Genders
18-64 years
Phase:
NA
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 m...
Detailed Description
There will be approximately 80 participants in this study: 40 who have lower-limb amputations and 40 who do not. A minimum of 48 hours will separate each testing session. A warm-up is incorporated i...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Individuals without Amputation:
- 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
- Exclusion Criteria for Individuals without Amputation:
- \- 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
- Inclusion Criteria for Individuals with Amputation:
- 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
- Exclusion Criteria for Individuals with Amputation:
- \- 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
- Have lower limb length from the knee to where the amputation occurred less than 10cm long
- 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
Exclusion
Key Trial Info
Start Date :
June 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06182202
Start Date
June 17 2022
End Date
May 31 2025
Last Update
December 26 2023
Active Locations (1)
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1
North Carolina State University
Raleigh, North Carolina, United States, 27695