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

NCT06830876 | Recruiting FDA Device

• 1 other identifier: NMES-PIT-24
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

residual limb; pain; gait

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  9 months

Secondary Outcomes (8)

• 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

Study Arms (1)

NMES

OTHER

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.

Device: Chattanooga Continuum Device

Interventions

Chattanooga Continuum Device 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.

Also known as: Continuum Device (EMPI)

NMES

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sara Peterson-Snyder: lead

Study Sites (1)

Cranberry Township Building

Pittsburgh, Pennsylvania, 16066, United States

RECRUITING

Related Publications (2)

• Snyder-Mackler L, Ladin Z, Schepsis AA, Young JC. Electrical stimulation of the thigh muscles after reconstruction of the anterior cruciate ligament. Effects of electrically elicited contraction of the quadriceps femoris and hamstring muscles on gait and on strength of the thigh muscles. J Bone Joint Surg Am. 1991 Aug;73(7):1025-36.

  PMID: 1874764 BACKGROUND

• Talbot LA, Gaines JM, Ling SM, Metter EJ. A home-based protocol of electrical muscle stimulation for quadriceps muscle strength in older adults with osteoarthritis of the knee. J Rheumatol. 2003 Jul;30(7):1571-8.

  PMID: 12858461 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kyle Leister, PhD

  East Tennessee Sate University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Peterson-Snyder, PhD

CONTACT

4127363131; sara@opclinicalinnovations.com

Kyle Leister, PhD

CONTACT

Leister@mail.etsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: co-investigator

Model Details: This is a pilot study, with a one-group, repeated measures experiment with individuals with unilateral transtibial limb loss (n=20) who are independent ambulators. A repeated measures design is chosen to gather additional data efficiently, using the unaffected side as the control.

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: February 17, 2025
• Study Start: December 10, 2024
• Primary Completion: August 30, 2025
• Study Completion: December 30, 2025
• Last Updated: February 17, 2025

Record last verified: 2024-12

Locations

US (1)