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Procedure
EMG-Controlled Prosthetic Ankle for Below Knee Amputation
N/A
Recruiting
Led By He Huang, PhD
Research Sponsored by North Carolina State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years or older
Has used the current socket for at least 6 months without a significant skin issue or major modification
Must not have
Cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the experiments
Cannot perform functional ambulation in the community on a daily basis without assistive devices
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-training (before the training starts), post-training (immediately after the training), and follow-up evaluation (one month) with both passive and demg devices
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to study the effects of training amputees to use direct electromyographic (dEMG) control of a powered prosthetic ankle. The study will focus on whether this training can
Who is the study for?
This trial is for individuals with below-knee amputations. Participants should be able to undergo physical therapy (PT) and use a direct electromyographic (dEMG) controlled prosthetic ankle. Specific inclusion or exclusion criteria are not provided.
What is being tested?
The study tests if using dEMG control of a powered prosthetic ankle improves balance, neuromuscular coordination, and reduces cognitive load in transtibial amputees compared to those using passive prostheses.
What are the potential side effects?
Potential side effects are not explicitly mentioned but may include muscle fatigue, skin irritation at the site of EMG electrode placement, or discomfort from adapting to new prosthetic technology.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I've used my current prosthetic socket for 6+ months without major skin problems or changes.
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I have had one of my legs amputated.
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I can walk with some assistance.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I can understand and follow simple instructions.
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I need help to walk daily outside my home.
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My remaining limb is very short, less than 15% the length of my other limb.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-training (before the training starts), post-training (immediately after the training), and follow-up evaluation (one month) with both passive and demg devices
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-training (before the training starts), post-training (immediately after the training), and follow-up evaluation (one month) with both passive and demg devices
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
aCOM, anticipatory Center of Mass Excursion when the expected disturbance is introduced
Secondary study objectives
Average muscle modules structure correlation
Frequency of stepping responses
Prosthesis Embodiment Scale
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: dEMG groupExperimental Treatment2 Interventions
Patients go through the training procedure with the direct EMG controlled powered prosthetic ankle.
Group II: Passive groupActive Control1 Intervention
Patients go through the training procedure with their own passive prosthetic ankles
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillOTHER
1,552 Previous Clinical Trials
4,268,074 Total Patients Enrolled
North Carolina State UniversityLead Sponsor
35 Previous Clinical Trials
13,960 Total Patients Enrolled
He Huang, PhDPrincipal InvestigatorNC State University
10 Previous Clinical Trials
332 Total Patients Enrolled
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