Detecting Change in Muscle Parameters, Pain, and Function with Neuromuscular Electrical Stimulation Treatment in Individuals Living with Transtibial Amputation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Chattanooga Continuum Device (Device)
结局指标
主要结局
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
时间窗: 9 months
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.
次要结局
- 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(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(9 months)
- To determine changes in chronic residual limb pain after 8 weeks of NMES at-home intervention.(9 months)
- To determine changes in phantom limb pain after 8 weeks of NMES at-home intervention.(9 months)
- To determine changes in phantom sensation after 8 weeks of NMES at-home intervention.(9 months)
- To determine changes in gait parameters of step length after (post) NMES at-home intervention when compared to baseline (pre) measures.(9 months)
- To determine changes in gait parameters in step width after (post) NMES at-home intervention when compared to baseline (pre) measures.(9 months)
- To determine changes in gait velocity after (post) NMES at-home intervention when compared to baseline (pre) measures.(9 months)
研究者
Sara Peterson-Snyder
co-investigator
O&P Clinical Innovations