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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Sara Peterson-Snyder
Study ID
NCT06830876
Status
Recruiting
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Conditions

  • Amputation

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Chattanooga Continuum Device — 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.

Study Details

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.

Key Dates

Start date
Dec 10, 2024
Status verified
Dec 2024
Primary completion
Aug 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

To determine changes in muscle thickness changes via US imaging in the residual limb of the VMO, TA, and GM muscles after 8 -weeks of NMES at-home intervention [ Time Frame: 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cranberry Township BuildingPittsburghPennsylvania16066
Sara L. Peterson, PhD
[email protected]
4127363131
Kyle Leister, PhD
Sara L. Peterson, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Cranberry Township Building· Pittsburgh, PA

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