Muscle Coordination Feedback + Electrical Stimulation for Stroke Rehabilitation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests new methods to improve walking and leg function in stroke survivors. Researchers compare traditional high-intensity walking exercises with treatments using electrical pulses and visual feedback to enhance muscle coordination. Participants will be divided into groups to try different therapy combinations. Ideal candidates are individuals who had a stroke over six months ago and can walk at least 10 meters independently, though they may use a cane or walker. As an unphased trial, this study provides participants the chance to explore innovative therapies that could enhance recovery and improve quality of life.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you have had a Botox injection in the lower limbs within the last 3 months or plan to have one during the study, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that functional electrical stimulation (FES) is generally well-received in stroke rehabilitation. A review of 25 studies found that FES-based treatments positively affect stroke recovery, particularly in improving movement. However, some studies noted that FES did not significantly enhance certain aspects of walking, such as the distance covered in a 6-minute walk for some patients.
For synergy-based multichannel FES, studies indicate it effectively enhances motor coordination and walking in stroke patients. This method uses multiple channels to stimulate different muscles and is considered safe and beneficial. Research supports its use in stroke rehabilitation due to positive feedback on improving motor function.
Muscle synergy visual biofeedback, which provides real-time feedback on muscle activity, has been studied for its role in rehabilitation. Evidence suggests it helps patients improve movement by aligning muscle activity with healthy patterns. Studies indicate it is a safe method with no significant adverse events reported.
Overall, current research findings suggest these treatments are well-tolerated and safe for use in stroke rehabilitation.12345Why are researchers excited about this trial?
Researchers are excited about the trial exploring Muscle Coordination Feedback and Electrical Stimulation for stroke rehabilitation because it introduces new ways to enhance motor recovery. Unlike traditional rehabilitation methods like physical therapy, which rely on repetitive physical exercises, this approach uses advanced electrical stimulation techniques to target specific muscle groups. The synergy-based multichannel FES (MFES) and muscle synergy visual biofeedback provide real-time feedback and stimulation, helping patients retrain their muscles more effectively. This combination aims to mimic natural muscle movements more closely, potentially leading to faster and more efficient recovery for stroke survivors.
What evidence suggests that this trial's treatments could be effective for stroke rehabilitation?
Research has shown that functional electrical stimulation (FES) can help stroke patients improve their walking ability. In one study, all participants who received FES could walk after treatment, and 84.6% returned home, compared to 53.3% in a group without FES. In this trial, participants in the "Standard FES to the Tibialis Anterior (TA)" arm will receive FES applied to the TA muscle/peroneal nerve. A more advanced version, synergy-based multichannel FES (MFES), is being tested in the "Synergy-Based Multichannel FES (MFES)" arm and has shown promising results, with noticeable improvements in walking speed and distance. When combined with visual biofeedback, as in the "Synergy-Based Multichannel (MFES) + Muscle Synergy Visual Biofeedback" arm, MFES also enhances movement quality. Visual biofeedback alone, tested in the "Muscle Synergy Visual Biofeedback" arm, aids recovery by encouraging patients to adjust their muscle movements to healthier patterns. These findings suggest that these techniques could significantly aid stroke rehabilitation.13567
Who Is on the Research Team?
Jose Pons, Ph.D
Principal Investigator
Shirley Ryan AbilityLab
Are You a Good Fit for This Trial?
This trial is for individuals aged 18-80 who have had a single unilateral stroke at least six months ago and can walk over 10 meters with or without an assistive device. They must be able to understand English, give consent, and have normal hearing and vision (correctable). Excluded are those with severe cognitive issues, aphasia, major medical conditions that could interfere with the study, pregnancy, prisoners, metallic/electrical implants in the body or significant spasticity in lower limbs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo gait training using various interventions including high-intensity gait training, standard FES, and novel muscle synergy-based interventions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Muscle Coordination-Based Feedback
Find a Clinic Near You
Who Is Running the Clinical Trial?
Shirley Ryan AbilityLab
Lead Sponsor