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

Phase

N/A

Condition

N/A

Treatment

Chattanooga Continuum Device

Clinical Study ID

NCT06830876

NMES-PIT-24

Ages 18-100
All Genders
Accepts Healthy Volunteers

Study 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

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 allowroom 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 ensureadequate sensation for NMES stimulation
Have a body mass index (BMI) of 35 kg/cm2 or less as NMES works more effectively onlower BMI

Exclusion

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

Study Design

Chattanooga Continuum Device

December 10, 2024

December 30, 2025

Study Description

This study investigates the efficacy of a home-based Neuromuscular Electrical Stimulation (NMES) intervention in improving muscle parameters, reducing pain, and enhancing gait biomechanics in individuals with unilateral transtibial amputation (TTA). Muscle atrophy and sarcopenia, common in individuals with amputations, result in reduced muscle strength, volume, and functional impairments. The NMES intervention aims to counter these deficits by promoting muscle hypertrophy and improving residual limb muscle quality.

Ultrasound (US) imaging, a safe and non-invasive technique, will be used to assess muscle composition and quality, focusing on muscle thickness (MT), cross-sectional area (CSA), and muscle fat infiltration (MFI) of key muscle groups, including the vastus medialis oblique (VMO), tibialis anterior (TA), and gastrocnemius (GM) muscles. Baseline measures will be compared to post-NMES intervention data to evaluate changes in muscle parameters.

Participants will undergo an 8-week NMES program using a portable device. Electrode placement and settings will be customized to target specific muscle groups for optimal stimulation and contraction. Anthropometric measurements, gait analysis, and self-reported pain levels will be collected at baseline, midpoint, and post-intervention. The study will utilize US imaging to validate changes in muscle composition and quality and examine improvements in gait parameters such as stride length, velocity, and step symmetry using the GAITRite® system.

This project is a critical step in addressing the lack of standardized rehabilitation protocols for individuals with TTA. By leveraging NMES and US imaging, the study aims to develop a cost-effective, accessible intervention that enhances prosthetic fit, stabilizes limb volume, and improves mobility. The findings will contribute to refining rehabilitation strategies and improving the quality of life for individuals with limb loss.

Connect with a study center

Cranberry Township Building
Pittsburgh, Pennsylvania 16066
United States
Active - Recruiting

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