NCT06099444

Muscle Coordination-Based Feedback for Stroke Rehabilitation

The Effects of Muscle Synergy-Based Biofeedback During Gait Rehabilitation for Individuals With Chronic Stroke

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years – 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	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.
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.
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.
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.

Timeline

• Start date: 2024-03-19
• Primary completion: 2028-10-01
• Completion: 2031-10-01
• First posted: 2023-10-25
• Last updated: 2025-05-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study