Improving muscle strength and reducing pain in amputees using electrical stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of a home-based Neuromuscular Electrical Stimulation (NMES) program for individuals with unilateral transtibial amputation. Over eight weeks, participants will use a portable NMES device to stimulate muscle growth and improve function in their residual limb. The study will assess changes in muscle parameters, pain levels, and gait biomechanics through ultrasound imaging and self-reported measures. The goal is to enhance mobility and overall well-being for amputees by addressing muscle atrophy and pain.

Why it matters

Who can join: the full rules

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

Where it's running

• Cranberry Township Building
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Kyle Leister, PhD — East Tennessee Sate University
• Study coordinator: Sara Peterson-Snyder, PhD
• Email: sara@opclinicalinnovations.com
• Phone: 4127363131

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.