Recruiting

NMES

Sponsor:

Sara Peterson-Snyder

Code:

NCT06830876

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Chattanooga Continuum Device

Study Details

Brief summary:

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

Study ID

NCT06830876

Start date

Dec 10, 2024

Status verified date

Dec, 2024

Completion date

Dec 30, 2025

Anticipated

Primary completion date

Aug 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: 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.

Interventions

Chattanooga Continuum Device

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.

Primary outcome measure

  • 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 [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Sara Peterson-Snyder, PhD

4127363131sara@opclinicalinnovations.com

Kyle Leister, PhD

Leister@mail.etsu.edu

Locations

Cranberry Township Building

Recruiting

Pittsburgh, Pennsylvania, United States, 16066

Contacts

Sara L. Peterson, PhD

4127363131sara@opclinicalinnovations.com

Principal Investigator:

Sara L. Peterson, PhD

More Information

Sponsor

Sara Peterson-Snyder

Last update posted

Feb 17, 2025

Last verified

Dec, 2024

Keywords

  • residual limb
  • pain
  • gait

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sara Peterson-Snyder on 2025-02-17.