Improving muscle strength and reducing pain in amputees using electrical stimulation
Detecting Change in Muscle Parameters, Pain, and Function With Neuromuscular Electrical Stimulation Treatment in Individuals Living With Transtibial Amputation
This study is testing a home-based electrical stimulation program to see if it can help people with a leg amputation build muscle strength and reduce pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | O&P Clinical Innovations Industry-sponsored |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT06830876 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a unilateral transtibial amputation who experience moderate pain and have adequate sensation in their residual limb.
Not a fit: Patients with severe diabetes, open wounds on the residual limb, or those who have recently used electrical stimulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve muscle strength, reduce pain, and enhance mobility for amputees.
How similar studies have performed: Previous studies have shown promising results with NMES in improving muscle function in various populations, suggesting potential success for this approach in amputees.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pittsburgh, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.