Cognitive Feedback for Motor Learning After Stroke

Overseen By Mindy Levin, PhD, PT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGill University

Disqualifiers: Neurological, Musculoskeletal, Proprioceptive, Visuospatial, Depression

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 28

Duration: 9 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to improve arm movement in people who have had a stroke. It tests the effectiveness of a virtual reality training program in aiding motor learning, focusing on feedback that shows exaggerated errors (Error Augmentation Feedback) to encourage better movement. The goal is to determine if this method helps stroke survivors, especially those with cognitive challenges, regain better use of their arms. Individuals who experienced a stroke within the last three years and have some arm movement difficulties might find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance rehabilitation methods for stroke survivors.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this training program is safe for stroke patients?

Research has shown that error augmentation (EA) feedback is generally well-received by stroke survivors. Studies have tested EA feedback for its ability to improve arm movement and coordination by intentionally exaggerating mistakes to enhance learning. These studies have not identified any major safety issues, suggesting that EA feedback is a safe method to help stroke patients improve motor skills.

While the studies do not list specific side effects, the absence of reported problems suggests that participants responded well to the treatment. This indicates that EA feedback could be a safe option for those aiming to regain better use of their arms after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cognitive Feedback for Motor Learning after Stroke trial because it's exploring a novel approach to rehabilitation using Error Augmentation (EA) feedback in virtual reality. Unlike traditional physical therapy, which focuses on repetitive movements to retrain the brain, this method uses deliberate error introduction to potentially accelerate motor learning. The idea is that by exaggerating movement errors, the brain can more effectively recalibrate and improve motor skills. This innovative use of virtual reality and cognitive feedback might offer a more engaging and potentially faster pathway to recovery for stroke survivors.

What evidence suggests that this trial's treatments could be effective for motor learning after stroke?

Research has shown that error augmentation (EA) feedback can aid stroke recovery by improving motor skills. In this trial, participants will be divided into two groups. One group will receive training with EA feedback, which exaggerates movement errors to help individuals make better adjustments, enhancing arm movement and overall recovery. The other group will undergo training without EA feedback. One study found that EA training led to better clinical scores compared to standard training methods. Another study demonstrated that EA is more effective than regular repetitive practice for improving movement and performance. This method shows promise for enhancing arm function in stroke survivors. ^{1 3 6 7 8}

Who Is on the Research Team?

Mindy Levin, PhD, PT

Principal Investigator

McGill University

Are You a Good Fit for This Trial?

This trial is for individuals who had their first stroke (ischemic or hemorrhagic) within the last 3 years, are stable and not currently in treatment. They must have normal vision (with or without correction), some arm weakness with a bit of spasticity but still able to bend and straighten the elbow around 30 degrees.

Inclusion Criteria

I had a stroke less than 3 years ago and am now medically stable.

I am not currently undergoing any cancer treatments.

My vision is normal or corrected to normal with glasses or contacts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo training with the EA-VR game, with or without EA feedback, for 30 minutes, 3 times a week for 9 weeks

9 weeks

27 visits (in-person)

Follow-up

Participants are monitored for changes in motor function and cognitive assessments 4 weeks after the completion of training

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Error Augmentation Feedback
• No Error Augmentation Feedback

Trial Overview The study tests if enhanced feedback during rehabilitation helps stroke survivors learn motor skills better. Participants use a virtual reality program that exaggerates errors in elbow movement, encouraging them to extend more than usual during exercises done three times weekly for nine weeks.

How Is the Trial Designed?

Group I: Training with EA feedback Experimental Treatment 1 Intervention

Subjects will undergo training with the EA-VR game that includes a 15 degree elbow flexion error.

Group II: Training without EA feedback Placebo Group 1 Intervention

Subjects will undergo training with the EA-VR game that does not include EA feedback.

Who Is Running the Clinical Trial?

McGill University

Lead Sponsor

Trials

421

Recruited

1,017,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Montreal Neurological Institute and Hospital

Collaborator

Trials

7

Recruited

2,200+

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Collaborator

Trials

17

Recruited

3,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8682915/

Error-augmented bimanual therapy for stroke survivors - PMC Stroke recovery studies have shown the efficacy of bimanual training on upper limb functional recovery and others have shown the efficacy of feedback technology ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07039006?lastUpdPost=2020-01-10_

Error Augmentation for Upper Limb Rehabilitation in Stroke ... This is a short, proof-of-concept study to evaluate whether EA feedback shows early promise for improving arm movement in people with upper limb motor ...

3. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-018-0408-5

The effects of error-augmentation versus error-reduction ... Results suggest, with a moderate level of evidence, that EA is overall more effective than conventional repetitive practice (motor recovery and performance) ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002%2Feng2.12720

Robotically driven Error Augmentation training enhances ... Error Augmentation training increased clinical scores compared to standard robotic training by 266% on the Motor Assessment Scale, and 88% on ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0966636217300760

Error augmentation feedback for lateral weight shifting This study examines the effect of error augmentation of center of pressure (CoP) visual feedback on the performance of a lateral weight shifting task.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5623679/

Effect of Error Augmentation on Brain Activation and Motor ... Our results suggest that to enhance learning of a locomotor task, errors should be augmented based on subjects' skill level.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8734943/

Error Augmentation Enhancing Arm Recovery in Individuals ... Neurorehabilitation studies suggest that manipulation of error signals during practice can stimulate improvement in coordination after stroke.

8. sralab.org sralab.org/research/projects/error-augmentation

Error-enhanced Learning & Recovery in 2 & 3 Dimensions This grant explores the prospects of artificially augmenting error as a means of enhancing the motor learning process and tests it on the recovering survivor ...