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

Description

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.

Conditions

Amputation
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Related Conditions:

Amputation

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Amputation
Intervention / Treatment

-

Contacts and Locations

Pittsburgh

Cranberry Township Building, Pittsburgh, Pennsylvania, United States, 16066

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Sara Peterson-Snyder,

Kyle Leister, PhD, PRINCIPAL_INVESTIGATOR, East Tennessee Sate University

Study Record Dates

2025-12-30