Actively Recruiting
Detecting Change in Muscle Parameters, Pain, and Function With NMES for TTA
Led by Sara Peterson-Snyder · Updated on 2025-02-17
20
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Detecting Change in Muscle Parameters, Pain, and Function With NMES for TTA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cranberry Township Building
Pittsburgh, Pennsylvania, United States, 16066
Actively Recruiting
Research Team
S
Sara Peterson-Snyder, PhD
CONTACT
K
Kyle Leister, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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