Detecting Change in Muscle Parameters, Pain, and Function With Neuromuscular Electrical Stimulation Treatment in Individuals Living With Transtibial Amputation

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: t
View:

• 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

Locations
United States
Pennsylvania
Cranberry Township Building
RECRUITING
Pittsburgh
Contact Information
Primary
Sara Peterson-Snyder, PhD
sara@opclinicalinnovations.com
4127363131
Backup
Kyle Leister, PhD
Leister@mail.etsu.edu
Time Frame
Start Date: 2024-12-10
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 20
Treatments
Other: NMES
All participants will undergo an 8-week Neuromuscular Electrical Stimulation (NMES) intervention using a portable NMES device at home. Participants will use the device on their residual limb to stimulate specific muscle groups (vastus medialis oblique, tibialis anterior, and gastrocnemius muscles). Electrode placement, stimulation intensity, and session frequency will be standardized and tailored to each participant to achieve strong but tolerable muscle contractions.
Related Therapeutic Areas
Sponsors
Leads: Sara Peterson-Snyder

This content was sourced from clinicaltrials.gov