Clinical trial NCT06830876: Detecting Change in Muscle Parameters, Pain, and Function With NMES for TTA
Official title: Detecting Change in Muscle Parameters, Pain, and Function With Neuromuscular Electrical Stimulation Treatment in Individuals Living With Transtibial Amputation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputation
Keywords: residual limb
pain
gait
Lead sponsor: O&P Clinical Innovations
Sponsor class: INDUSTRY
First posted: 2025-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
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
timeFrame: 9 months
Secondary outcomes:
measure: 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
timeFrame: 9 months
measure: 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
timeFrame: 9 months
measure: To determine changes in chronic residual limb pain after 8 weeks of NMES at-home intervention.
timeFrame: 9 months
measure: To determine changes in phantom limb pain after 8 weeks of NMES at-home intervention.
timeFrame: 9 months
measure: To determine changes in phantom sensation after 8 weeks of NMES at-home intervention.
timeFrame: 9 months
measure: To determine changes in gait parameters of step length after (post) NMES at-home intervention when compared to baseline (pre) measures.
timeFrame: 9 months
measure: To determine changes in gait parameters in step width after (post) NMES at-home intervention when compared to baseline (pre) measures.
timeFrame: 9 months
measure: To determine changes in gait velocity after (post) NMES at-home intervention when compared to baseline (pre) measures.
timeFrame: 9 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Cranberry Township Building
state: Pennsylvania
Study officials:
affiliation: East Tennessee Sate University
name: Kyle Leister, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.