RecruitingNot ApplicableNCT06830876

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

Sponsor

Sara Peterson-Snyder

Enrollment

20 participants

Start Date

Dec 10, 2024

Study Type

INTERVENTIONAL

Conditions

Amputation

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

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria7

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 Criteria5

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

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Interventions

DEVICEChattanooga 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.