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

Recruiting now · Not applicable

Conditions studied: Amputation

In brief

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.

Key facts

Study ID: NCT06830876
Run by: Sara Peterson-Snyder
People needed: 20
Starts: 2024-12-10
Expected to finish: 2025-12-30
Last updated by the study team: 2025-02-17

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Cranberry Township Building — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.