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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

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.Check my eligibility
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.See study design
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 below
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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:
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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 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
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-training (before the training starts), post-training (immediately after the training), and follow-up evaluation (one month) with both passive and demg devices for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
aCOM, anticipatory Center of Mass Excursion when the expected disturbance is introduced
Secondary outcome measures
Average muscle modules structure correlation
Frequency of stepping responses
Prosthesis Embodiment Scale
+3 more

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
1,526 Previous Clinical Trials
4,197,187 Total Patients Enrolled
North Carolina State UniversityLead Sponsor
34 Previous Clinical Trials
15,560 Total Patients Enrolled
He Huang, PhDPrincipal InvestigatorNC State University
10 Previous Clinical Trials
332 Total Patients Enrolled
~33 spots leftby Jul 2027