NCT06830876

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Sara Peterson-Snyder · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Amputation

Interventions

Type	Name	Description
DEVICE	Chattanooga Continuum Device	The Chattanooga Continuum (Enovis, Wilmington, DE) is an FDA-approved, multi-functional, dual-channel electrotherapy device that offers adjunctive rehabilitation therapies, including muscle re-education (NMES), pain control, and stimulation of local blood circulation. The device provides a treatment duration of up to 60 minutes, allowing for cycled or continuous therapy. It offers symmetrical and asymmetrical waveform types, adjustable pulse rates of up to 150 Hz, and pulse width durations of up to 400 μs. The device also features off times, channel ramp times, and on time settings. Additionally, the Continuum is equipped with a data and parameter logger, enabling the monitoring of patient usage. It incorporates an automatic lock function to prevent accidental changes in intensity by preventing unintended pressing of the control buttons. The device operates on two AA rechargeable NiMH batteries, and a battery charger and extra batteries are included with the device.

Timeline

• Start date: 2024-12-10
• Primary completion: 2025-08-30
• Completion: 2025-12-30
• First posted: 2025-02-17
• Last updated: 2025-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study