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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Amputation
• Intervention / Treatment: Device: Chattanooga Continuum Device

Detailed Description

This study investigates the efficacy of a home-based Neuromuscular Electrical Stimulation (NMES) intervention in improving muscle parameters, reducing pain, and enhancing gait biomechanics in individuals with unilateral transtibial amputation (TTA). Muscle atrophy and sarcopenia, common in individuals with amputations, result in reduced muscle strength, volume, and functional impairments. The NMES intervention aims to counter these deficits by promoting muscle hypertrophy and improving residual limb muscle quality.

Ultrasound (US) imaging, a safe and non-invasive technique, will be used to assess muscle composition and quality, focusing on muscle thickness (MT), cross-sectional area (CSA), and muscle fat infiltration (MFI) of key muscle groups, including the vastus medialis oblique (VMO), tibialis anterior (TA), and gastrocnemius (GM) muscles. Baseline measures will be compared to post-NMES intervention data to evaluate changes in muscle parameters.

Participants will undergo an 8-week NMES program using a portable device. Electrode placement and settings will be customized to target specific muscle groups for optimal stimulation and contraction. Anthropometric measurements, gait analysis, and self-reported pain levels will be collected at baseline, midpoint, and post-intervention. The study will utilize US imaging to validate changes in muscle composition and quality and examine improvements in gait parameters such as stride length, velocity, and step symmetry using the GAITRite® system.

This project is a critical step in addressing the lack of standardized rehabilitation protocols for individuals with TTA. By leveraging NMES and US imaging, the study aims to develop a cost-effective, accessible intervention that enhances prosthetic fit, stabilizes limb volume, and improves mobility. The findings will contribute to refining rehabilitation strategies and improving the quality of life for individuals with limb loss.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Peterson-Snyder, PhD; Phone Number: 4127363131; Email: sara@opclinicalinnovations.com
• Study Contact Backup: Name: Kyle Leister, PhD; Email: Leister@mail.etsu.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 16066
      • Recruiting
      • Cranberry Township Building
      • Contact: Sara L. Peterson, PhD; Phone Number: 4127363131; Email: sara@opclinicalinnovations.com
      • Contact: Kyle Leister, PhD
      • Contact: Sara L. Peterson, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Device: 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.; Other Names: Continuum Device (EMPI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Compared to baseline, amputees' residual limb will show changes in Muscle Cross-sectional area (CSA) measured in centimeters (cm) post-NMES 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	Compared to baseline, amputees' residual limb will show changes in Muscle Fat Infiltration (MFI) or myosteatosis post-NMES intervention using values between 0 and 255 (0: black; 255: white) and scored with the Modified Heckmatt scale as z-scores.	9 months
To determine changes in chronic residual limb pain after 8 weeks of NMES at-home intervention.	NMES intervention will show changes in chronic residual limb pain after (post) intervention when compared to baseline (pre) as measured by a pain questionnaire designed for amputees measured using a numeric rating scale 0-10, 0 being no pain and 10 being the highest pain imaginable.	9 months
To determine changes in phantom limb pain after 8 weeks of NMES at-home intervention.	NMES intervention will show changes in phantom limb pain after (post) intervention when compared to baseline (pre) as measured by a pain questionnaire designed for amputees measured using a numeric rating scale 0-10, 0 being no pain and 10 being the highest pain imaginable.	9 months
To determine changes in phantom sensation after 8 weeks of NMES at-home intervention.	NMES intervention will show changes in phantom sensation after (post) intervention when compared to baseline (pre) as measured by a pain questionnaire designed for amputees measured using a numeric rating scale 0-10, 0 being no pain and 10 being the highest pain imaginable.	9 months
To determine changes in gait parameters of step length after (post) NMES at-home intervention when compared to baseline (pre) measures.	NMES intervention will show changes in gait parameters of step length in meters (post) intervention when compared to baseline (pre) measures with the use of a Gait Rite mat.	9 months
To determine changes in gait parameters in step width after (post) NMES at-home intervention when compared to baseline (pre) measures.	NMES intervention will show changes in gait parameters of step width in meters of the amputated side (post) intervention when compared to baseline (pre) measures with the use of a Gait Rite mat.	9 months
To determine changes in gait velocity after (post) NMES at-home intervention when compared to baseline (pre) measures.	NMES intervention will show changes in gait velocity (meters/time) after (post) intervention when compared to baseline (pre) measures with the use of a Gait Rite mat.	9 months

Collaborators and Investigators

• Sponsor: Sara Peterson-Snyder
• Investigators: Principal Investigator: Kyle Leister, PhD, East Tennessee Sate University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: pain; gait; residual limb
• Other Study ID Numbers: NMES-PIT-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes