Muscle Coordination-Based Feedback for Stroke Rehabilitation

NCT06099444 | Active Not Recruiting FDA Device

• 1 other identifier: STU00218244
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare two interventions currently used to improve gait and lower limb function in individuals with chronic stroke (i.e., high-intensity gait training and high-intensity gait training with functional electrical stimulation (FES)) with novel interventions based on the coordinated activity of multiple muscles, known as muscle synergies. To this end, the researchers will recruit chronic stroke patients to participate in training protocols according to the currently used rehabilitation programs as well as novel rehabilitation programs that provide real time feedback of muscle synergies using multichannel FES and visual feedback.

Conditions

Stroke

Keywords

Stroke; Functional Electrical Stimulation (FES); Gait Rehabilitation; Stroke Rehabilitation; Muscle Synergies

Outcome Measures

Primary Outcomes (1)

• Change in muscle synergies during walking

  Muscle synergies are groups of muscles that receive a common input from the brain. The researchers will assess the number of muscle synergies and the similarity of muscle synergies to those of healthy individuals. The researchers will calculate from the electromyographic (EMG) activity and compare the number and similarity of muscle synergies to healthy individuals via a similarity index. These measures will be assessed between legs, over time, and between groups. An increase in number of synergies and an improvement in similarity of synergies is a better outcome.

  Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions

Secondary Outcomes (24)

• Change in 10 Meter Walk Test

  Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions

• Change in 6 Minute Walk Test

  Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions

• Change in Berg Balance Scale

  Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions

• Change in Functional Gait Assessment (FGA)

  Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions

• Change in Manual Muscle Test

  Baseline, Mid-Assessment after 3 weeks of training, Post-Assessment after full 6 weeks of training, and 1-month follow-up after completion of training sessions

Study Arms (5)

Conventional High Intensity Gait Training

ACTIVE COMPARATOR

Participants in the conventional high-intensity gait training group will undergo gait training on a treadmill. Each session will consist of between 30-60 minutes of walking targeted to reach a high intensity, as measured via heart rate and Borg rating of perceived exertion. This may also include inclined walking, walking with an ankle weight, backwards walking, sidestepping, and/or obstacle walking.

Device: Conventional High Intensity Gait Training

Standard FES to the Tibialis Anterior (TA)

EXPERIMENTAL

Participants in the standard FES gait training group will receive FES applied to the TA muscle/peroneal nerve on his/her more affected leg. FES strategically stimulates the TA/peroneal nerve at specific phases of the gait cycle identified by internal inertial measurement units (IMUs).

Device: Standard FES to the Tibialis Anterior (TA)

Synergy-Based Multichannel FES (MFES)

EXPERIMENTAL

Participants in the synergy-based MFES gait training group will receive FES applied to muscles of the affected lower limb. These muscles may include the TA, gastrocnemius medialis, gastrocnemius lateralis, soleus, rectus femoris, vastus medialis, vastus lateralis, semitendinosus, biceps femoris, gluteus medius, and adductor longus. FES will be applied to each muscle with an activation pattern that is derived from extracted healthy muscle synergies that are scaled to fit the patient's gait cycle.

Device: Synergy-Based Multichannel FES (MFES)

Muscle Synergy Visual Biofeedback

EXPERIMENTAL

Participants in the muscle synergy visual biofeedback group will wear bipolar EMG sensors on the muscles of interest. In real time, muscle synergies will be extracted and the similarity of affected synergies to healthy synergies will be displayed on a screen. Patients in this group will be instructed to try to increase the similarity score of the affected synergies and the healthy synergies. No electrical stimulation will be provided in this group.

Device: Muscle Synergy Visual Biofeedback

Synergy-Based Multichannel (MFES) + Muscle Synergy Visual Biofeedback

EXPERIMENTAL

Participants in the group will receive a combination of the synergy-based MFES and muscle synergy visual biofeedback interventions. Because EMG cannot be recorded while FES is being applied in a continuous fashion, this method will alternate between providing sensory feedback (FES) and visual feedback of the muscle synergies.

Device: Synergy-Based Multichannel FES (MFES); Device: Muscle Synergy Visual Biofeedback

Interventions

Conventional High Intensity Gait Training DEVICE

Participants during a training session will complete at least 30 minutes of treadmill walking at the target intensity. The participants will complete 18 training sessions.

Conventional High Intensity Gait Training

Standard FES to the Tibialis Anterior (TA) DEVICE

Participants during a training session will complete at least 30 minutes of treadmill walking at the target intensity while wearing a FES stimulator on the tibialis anterior muscle of their more affected leg. Stimulation will be triggered prior to swing phase to combat drop foot. The participants will complete 18 training sessions.

Standard FES to the Tibialis Anterior (TA)

Synergy-Based Multichannel FES (MFES) DEVICE

Participants during a training session will complete at least 30 minutes of treadmill walking at the target intensity while FES is applied to multiple muscles of the leg throughout the gait cycle based on the healthy muscle synergies. The goal will be to have the FES applied for at least 20 minutes of each gait training session. The participants will complete 18 training sessions.

Synergy-Based Multichannel (MFES) + Muscle Synergy Visual Biofeedback; Synergy-Based Multichannel FES (MFES)

Muscle Synergy Visual Biofeedback DEVICE

Participants during a training session will complete at least 30 minutes of treadmill walking at the target intensity while receiving visual feedback of the similarity of their muscle synergies to healthy muscle synergies. They will be instructed to try to optimize the similarity score. The participants will complete 18 training sessions.

Muscle Synergy Visual Biofeedback; Synergy-Based Multichannel (MFES) + Muscle Synergy Visual Biofeedback

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-80 years, inclusive
• Normal hearing and vision, can be corrected
• Able to understand and give informed consent
• Able to understand and speak English

You may not qualify if:

• Reduced cognitive function or inability to perform study tasks
• Any neurological disorder or history of neurological injuries (e.g., Parkinson's disease or other neurodegenerative disorder, dementia, brain injury, spinal cord injury, multiple sclerosis, peripheral nerve injury, or cancer of the central nervous system)
• Presence of pathology that could cause abnormal movements of extremities (e.g., epilepsy, marked arthritis, chronic pain, musculoskeletal injuries)
• Recent fracture or osteoporosis (as reported by subject)
• Lesions or wounds on the legs
• Medical (cardiac, renal, hepatic, or oncological) or psychiatric disease that would interfere with study procedures
• Pregnancy
• Prisoners
• Patients:
• Age 18-80 years, inclusive
• Normal hearing and vision, can be corrected
• History of a single unilateral, supratentorial ischemic or hemorrhagic stroke at least six months prior
• Reduced ambulation but able to walk \>10m independently on level ground (with assistive device if needed)
• Medical clearance from medical team (signed Medical Clearance form)
• Able to understand and give informed consent

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jose L Pons, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors who do not know subject group assignments will perform the assessments.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 25, 2023
• Study Start: March 19, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2031
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)