Detecting Change in Muscle Parameters, Pain, and Function With NMES for TTA
Detecting Change in Muscle Parameters, Pain, and Function With Neuromuscular Electrical Stimulation Treatment in Individuals Living With Transtibial Amputation
Who can join
Ages 18 to 100 · All sexes · Healthy volunteers welcome
Full eligibility 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
About the study
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, and overall well-being of amputees, addressing challenges and reducing healthcare burdens.
What is being tested
- Chattanooga Continuum Device (device)
Sponsor: Sara Peterson-Snyder · Participants: 20 · Started: Dec 10, 2024
Contact the study team
- Sara Peterson-Snyder, PhD · Phone: 4127363131
Official record on ClinicalTrials.gov — NCT06830876
Locations in the U.S.
| Pennsylvania | Cranberry Township Building, Pittsburgh |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.