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Detecting Change in Muscle Parameters, Pain, and Function With NMES for TTA

RecruitingNAAges 18 Years - 100 YearsAllSara Peterson-Snyder
NCT06830876 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The proposal aims to investigate a non-invasive, cost-effective method for rebuilding muscle mass in individuals with transtibial limb loss. Maintaining a healthy, pain-free residual limb is a primary concern for prosthesis users. Amputees commonly experience muscle deficits leading to mobility issues, poor prosthetic fit, and chronic pain. Neuromuscular electrical stimulation (NMES) is a potential intervention that activates muscles with low-level electrical stimulation, improving strength, function, and reducing pain. The study seeks to understand NMES's effects on muscle parameters and pain to develop evidence-based interventions for amputees. Twenty participants with transtibial amputations will undergo an 8-week NMES training program. Ultrasound imaging will assess muscle thickness, cross-sectional area, and composition changes. The study aims to enhance mobility, prosthetic fit,

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📋 Eligibility rules (as published)
Inclusion Criteria: * 18 years or older * Have a unilateral transtibial amputation * Have normal sound limb range of motion and function * Have a minimum of 4" length limb from tibial tubercle to end of residuum to allow room for NMES pads * Report current pain at a level 3 or higher on a Visual Analog Scale (VAS) * Pass a monofilament test on the residual limb in 7 out of 10 areas to ensure adequate sensation for NMES stimulation * Have a body mass index (BMI) of 35 kg/cm2 or less as NMES works more effectively on lower BMI Exclusion Criteria: * Have used electrical stimulation on the residual limb in the past six months * Have been diagnosed as a severe diabetic or self-report insensate skin * Have the presence of open wounds/ulcers on the residual limb * Have experienced a cerebrovascular accident (stroke) or nerve injury to a lower limb * Wear a pacemaker or implanted cardiac defibrillator
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What it tests

  • Chattanooga Continuum Device
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Where

1 site
Cranberry Township Building
Pittsburgh, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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