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

Sara Peterson-Snyder · NCT06830876

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–100 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
20
US sites recruiting
1
Study start
December 10, 2024
Record last updated
February 17, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Chattanooga Continuum Device

Conditions: Amputation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion 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

Exclusion Criteria

  • 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

Recruiting US locations

  • Cranberry Township Building

    Pittsburgh, PA 16066

    Site contact: Sara L. Peterson, PhD · 4127363131 · sara@opclinicalinnovations.com

Study contacts (from the official record)

  • Sara Peterson-Snyder, PhD · 4127363131 · sara@opclinicalinnovations.com
  • Kyle Leister, PhD · Leister@mail.etsu.edu
All healthy volunteers studies in Pennsylvania →
Detecting Change in Muscle Parameters, Pain, and Function With… (NCT06830876) | Bored Studies