RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-12-10
Study Completion:2025-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06830876

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.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years or older
  2. * Have a unilateral transtibial amputation
  3. * Have normal sound limb range of motion and function
  4. * Have a minimum of 4" length limb from tibial tubercle to end of residuum to allow room for NMES pads
  5. * Report current pain at a level 3 or higher on a Visual Analog Scale (VAS)
  6. * Pass a monofilament test on the residual limb in 7 out of 10 areas to ensure adequate sensation for NMES stimulation
  7. * Have a body mass index (BMI) of 35 kg/cm2 or less as NMES works more effectively on lower BMI
  1. * Have used electrical stimulation on the residual limb in the past six months
  2. * Have been diagnosed as a severe diabetic or self-report insensate skin
  3. * Have the presence of open wounds/ulcers on the residual limb
  4. * Have experienced a cerebrovascular accident (stroke) or nerve injury to a lower limb
  5. * Wear a pacemaker or implanted cardiac defibrillator

Contacts and Locations

Study Contact

Sara Peterson-Snyder, PhD
CONTACT
4127363131
sara@opclinicalinnovations.com
Kyle Leister, PhD
CONTACT
Leister@mail.etsu.edu

Principal Investigator

Kyle Leister, PhD
PRINCIPAL_INVESTIGATOR
East Tennessee Sate University

Study Locations (Sites)

Cranberry Township Building
Pittsburgh, Pennsylvania, 16066
United States

Collaborators and Investigators

Sponsor: Sara Peterson-Snyder

  • Kyle Leister, PhD, PRINCIPAL_INVESTIGATOR, East Tennessee Sate University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-10
Study Completion Date2025-12-30

Study Record Updates

Study Start Date2024-12-10
Study Completion Date2025-12-30

Terms related to this study

Keywords Provided by Researchers

  • residual limb
  • pain
  • gait

Additional Relevant MeSH Terms

  • Amputation