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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 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 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

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

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 more

Awards & 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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillOTHER

1,551 Previous Clinical Trials

4,267,850 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

~33 spots leftby Jul 2027

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