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Procedure

Powered Prosthesis for Amputation

N/A
Recruiting
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
Are 18 years of age or older
Be between 18 and 65 years old
Must not have
Have had a stroke
Have heart disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (an average of 36 months).
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to understand how amputees control their muscles in order to improve the design of prosthetic limbs. The researchers will compare the muscle activity in non-amputated individuals and amputees

Who is the study for?
This trial is for lower limb amputees who use a prosthetic to stay active and independent. It's also for non-amputee individuals as a comparison group. The study aims to understand muscle control in both groups during various tasks.
What is being tested?
The research focuses on comparing the muscle activity of amputated limbs with that of intact muscles in non-amputees. This will help improve how powered prostheses are controlled based on residual muscle signals.
What are the potential side effects?
Since this trial involves analysis rather than medication or invasive procedures, there are minimal side effects expected. Participants may experience discomfort from the sensors used to measure muscle activity.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a stroke.
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I have heart disease.
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I weigh less than 450 pounds.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (an average of 36 months).
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (an average of 36 months). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Motor Unit Action Potential Amplitudes
Motor Unit Coherence
Secondary study objectives
Muscle Architecture Properties -- Muscle Volume

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: Individuals With AmputationExperimental Treatment1 Intervention
Tasks with a passive prosthesis Tasks with a powered active prosthesis
Group II: Individuals Without AmputationActive Control1 Intervention
No Intervention Tested in identical tasks for comparison to Individuals with Amputation

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Who is running the clinical trial?

North Carolina State UniversityLead Sponsor
35 Previous Clinical Trials
13,930 Total Patients Enrolled
~0 spots leftby Dec 2024
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