Muscle Coordination-Based Feedback for Stroke Rehabilitation

NCT ID: NCT06099444

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-19
• Study Completion Date: 2031-10-01

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.

Detailed Description

The researchers will determine if using muscle synergies to drive interventions provides greater rehabilitation outcomes than the interventions that are currently used in therapy. Then, the researchers aim to investigate which modality of feedback (somatosensory vs visual) on muscle synergies may result in the greatest improvements. Therefore, we will have two aims. The main objective of Aim 1 of this study is to compare 1) conventional high-intensity gait training, 2) standard FES gait training, and 3) a novel muscle synergy-based multichannel FES (MFES) gait training for the purpose of improving lower limb function (i.e., gait) in individuals with chronic stroke. The main objective of Aim 2 of this study is to compare 1) muscle synergy-based MFES gait training, 2) muscle synergy visual biofeedback gait training, and 3) a combination of synergy-based MFES and muscle synergy visual biofeedback gait training to determine the key modality to driving neuroplastic change in the organization of muscle synergies during gait training. To this end, the researchers will randomly enroll 15 patients with chronic stroke to one of the three rehabilitation programs/groups listed above in each aim and assess the efficacy of each program to improve the following patient outcomes throughout and following rehabilitation:

1. Changes in functional impairment measured by clinical assessments.

2. Changes in gait biomechanics.

3. Electrophysiological changes in motor control.

4. Feasibility of clinical use of novel interventions and the perceived usefulness by patients.

This will provide information about the potential advantages of using the novel synergy-based biofeedback systems in a chronic stroke population and may be the foundation for a larger clinical trial and extension of this rehabilitation technology to the subacute stroke population as well as other neurologically impaired populations.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Conventional High Intensity Gait Training

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.

Group Type: ACTIVE_COMPARATOR

Conventional High Intensity Gait Training

Intervention Type: 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.

Standard FES to the Tibialis Anterior (TA)

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).

Group Type: EXPERIMENTAL

Standard FES to the Tibialis Anterior (TA)

Intervention Type: 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.

Synergy-Based Multichannel FES (MFES)

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.

Group Type: EXPERIMENTAL

Synergy-Based Multichannel FES (MFES)

Intervention Type: 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.

Muscle Synergy Visual Biofeedback

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.

Group Type: EXPERIMENTAL

Muscle Synergy Visual Biofeedback

Intervention Type: 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.

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

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.

Group Type: EXPERIMENTAL

Synergy-Based Multichannel FES (MFES)

Intervention Type: 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.

Muscle Synergy Visual Biofeedback

Intervention Type: 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.

Interventions

Conventional High Intensity Gait Training

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.

Intervention Type: DEVICE

Standard FES to the Tibialis Anterior (TA)

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.

Intervention Type: DEVICE

Synergy-Based Multichannel FES (MFES)

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.

Intervention Type: DEVICE

Muscle Synergy Visual Biofeedback

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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
• Able to understand and speak English
• Able to passively move all joints (i.e., hip, knee, ankle) through the range of motion of a typical gait cycle

• Licensed physical therapist at SRALab
• At least 1 year of experience as a physical therapist
• Regularly treats people with stroke, at minimum once per week
• Able to give informed consent
• Active CITI training certification, or willing to complete this online CITI training

Exclusion Criteria

• 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:

• Reduced cognitive function and inability to perform study tasks
• Severe aphasia
• Co-existence of other neurological diseases (e.g., Parkinson's disease or other neurodegenerative disorder, dementia, brain injury, spinal cord injury, multiple sclerosis, or cancer of the central nervous system)
• History of peripheral nerve injury
• Severe hip, knee, or ankle arthritis
• Recent fracture or osteoporosis (as reported by subject)
• Medical (cardiac, renal, hepatic, or oncological) or psychiatric disease that would interfere with study procedures
• Significant spasticity or contracture in the lower limbs (Modified Ashworth Scale score of 3 or higher)
• Use of pacemakers, defibrillators, electrical implants, or metallic implants
• Lesions or wounds on the paretic leg
• Botox (botulinum toxin) injection to lower limbs within the prior 3 months, or planned injection during study period
• Pregnancy
• Prisoners
• Concurrent or planned participation in surgeries, significant medical treatments, other lower limb research studies, or physical therapy during the study timeline

Therapists:

• Inability to interact safety with the technologies
• Unwillingness to try to use the technologies
• Unable to complete at least 1 competency session and deliver at least 6 intervention sessions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Jose Pons

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose L Pons, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00218244

Identifier Type: -

Identifier Source: org_study_id