NCT06830876 Detecting Change in Muscle Parameters, Pain, and Function With NMES for TTA
| NCT ID | NCT06830876 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sara Peterson-Snyder |
| Condition | Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-12-10 |
| Primary Completion | 2025-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-12-10 with a primary completion date of 2025-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Kyle Leister, PhD
PRINCIPAL INVESTIGATOR
East Tennessee Sate University
Frequently Asked Questions
Who can join the NCT06830876 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06830876 currently recruiting?
Yes, NCT06830876 is actively recruiting participants. Contact the research team at sara@opclinicalinnovations.com for enrollment information.
Where is the NCT06830876 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT06830876 clinical trial?
NCT06830876 is sponsored by Sara Peterson-Snyder. The principal investigator is Kyle Leister, PhD at East Tennessee Sate University. The trial plans to enroll 20 participants.