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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Cranberry Township Building
Pittsburgh, Pennsylvania, United States
RECRUITINGTo 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
Compared to baseline, amputees' residual limb will show changes in Muscle Thickness (MT) measured in centimeters (cm) of the vastus medialis oblique (VMO), Tibialis Anterior (TA) and gastrocnemius muscles (GM) post-NMES intervention.
Time frame: 9 months
To determine changes in muscle cross-sectional area (CSA) via US imaging in the residual limb of the VMO, TA, and GM muscles after 8 -weeks of NMES at-home intervention
Compared to baseline, amputees' residual limb will show changes in Muscle Cross-sectional area (CSA) measured in centimeters (cm) post-NMES intervention.
Time frame: 9 months
To determine changes in Muscle Fat Infiltration (MFI) or myosteatosis via US imaging in the residual limb of the VMO, TA, and GM muscles after 8 -weeks of NMES at-home intervention
Compared to baseline, amputees' residual limb will show changes in Muscle Fat Infiltration (MFI) or myosteatosis post-NMES intervention using values between 0 and 255 (0: black; 255: white) and scored with the Modified Heckmatt scale as z-scores.
Time frame: 9 months
To determine changes in chronic residual limb pain after 8 weeks of NMES at-home intervention.
NMES intervention will show changes in chronic residual limb pain after (post) intervention when compared to baseline (pre) as measured by a pain questionnaire designed for amputees measured using a numeric rating scale 0-10, 0 being no pain and 10 being the highest pain imaginable.
Time frame: 9 months
To determine changes in phantom limb pain after 8 weeks of NMES at-home intervention.
NMES intervention will show changes in phantom limb pain after (post) intervention when compared to baseline (pre) as measured by a pain questionnaire designed for amputees measured using a numeric rating scale 0-10, 0 being no pain and 10 being the highest pain imaginable.
Time frame: 9 months
To determine changes in phantom sensation after 8 weeks of NMES at-home intervention.
NMES intervention will show changes in phantom sensation after (post) intervention when compared to baseline (pre) as measured by a pain questionnaire designed for amputees measured using a numeric rating scale 0-10, 0 being no pain and 10 being the highest pain imaginable.
Time frame: 9 months
To determine changes in gait parameters of step length after (post) NMES at-home intervention when compared to baseline (pre) measures.
NMES intervention will show changes in gait parameters of step length in meters (post) intervention when compared to baseline (pre) measures with the use of a Gait Rite mat.
Time frame: 9 months
To determine changes in gait parameters in step width after (post) NMES at-home intervention when compared to baseline (pre) measures.
NMES intervention will show changes in gait parameters of step width in meters of the amputated side (post) intervention when compared to baseline (pre) measures with the use of a Gait Rite mat.
Time frame: 9 months
To determine changes in gait velocity after (post) NMES at-home intervention when compared to baseline (pre) measures.
NMES intervention will show changes in gait velocity (meters/time) after (post) intervention when compared to baseline (pre) measures with the use of a Gait Rite mat.
Time frame: 9 months
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