Error-enhanced Learning for Stroke Recovery

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by James Patton, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Botox

Disqualifiers: Bilateral paresis, Severe spasticity, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial uses a robotic arm and virtual reality to help stroke patients practice reaching exercises tailored to their specific mistakes. By understanding and correcting these mistakes, the therapy aims to improve arm movement. Virtual reality (VR) technology is a novel adjunctive therapy that could be applied in neurorehabilitation.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have had a Botox injection in the affected arm within the last 4 months, you cannot participate.

What data supports the effectiveness of the treatment Error-enhanced Learning for Stroke Recovery?

Research shows that using feedback, such as position or auditory cues, during reaching exercises can help improve movement in stroke patients. Studies found that emphasizing movement errors and using error-augmentation techniques can enhance motor learning and recovery, suggesting that these methods could be effective in stroke rehabilitation. ^{1 2 3 4 5}

Is Error-enhanced Learning for Stroke Recovery safe for humans?

The studies on error-enhanced learning techniques, such as using feedback during reaching exercises for stroke recovery, suggest that these methods are generally safe for humans. Participants in these studies did not report any adverse effects, and the techniques have shown potential for improving motor skills in stroke patients. ^{2 3 6 7 8}

How is the treatment 'Customized Reaching Exercise' different from other treatments for stroke recovery?

This treatment is unique because it uses error-enhancement, where mistakes are temporarily exaggerated to help patients learn and adapt better. It involves personalized exercises with feedback, often using robotic devices, to improve reaching ability in stroke patients, which is different from standard therapies that may not focus on error magnification. ^{2 3 4 6 9}

Research Team

James Patton, PhD

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

This trial is for adults over 18 who have had a stroke at least 8 months ago, affecting the primary motor cortex but still retain some shoulder and elbow movement. It's not suitable for those with severe medical issues, recent Botox in the arm, bilateral paresis, multiple strokes or lesions, severe sensory deficits, high spasticity preventing movement, cognitive impairments that affect task performance or those already in upper extremity rehab.

Inclusion Criteria

I had a stroke over 8 months ago affecting my movement control area.

I have weakness on one side of my body.

I am 18 years old or older.

Exclusion Criteria

I have severe health issues right now.

I have weakness in both sides of my body.

You have participated in a similar study involving robotics before.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants undergo reaching exercises using robotic arm and virtual reality display system

2 weeks

6 visits (in-person)

Post-Evaluation

Participants complete post-treatment evaluations to assess changes

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

1 visit (in-person)

Treatment Details

Interventions

• Customized Reaching Exercise (Behavioural Intervention)

Trial Overview The study tests how making mistakes during exercises can help improve arm function after a stroke. Participants will reach for targets using their affected arm while researchers track errors to tailor an exercise program aimed at enhancing recovery based on individual error patterns.

Participant Groups

Group I: Group 2 Experimental Treatment 2 Interventions

Group II: Group 1 Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Dr. Pablo Celnik

Shirley Ryan AbilityLab

Chief Executive Officer since 2023

MD from University of Buenos Aires Faculty of Medical Sciences

Dr. James Sliwa

Shirley Ryan AbilityLab

Chief Medical Officer since 2021

DO

Findings from Research

In a study involving 158 recovering stroke patients, both trained and untrained movements showed improvements, indicating that motor learning allows for generalization of skills rather than requiring specific training for each task.

The results suggest that focusing on a smaller set of activities during rehabilitation may be more effective, as the brain appears to rebuild task representations through motor learning, which could optimize therapy design for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning, not adaptation, characterizes stroke motor recovery: evidence from kinematic changes induced by robot-assisted therapy in trained and untrained task in the same workspace. Dipietro, L., Krebs, HI., Volpe, BT., et al.[2021]

In a pilot study with 5 chronic stroke patients, position feedback during upper limb reach training led to improvements in kinematic variables, indicating enhanced motor learning.

Subjects required only a small percentage (7.4% to 14.7%) of training time for position feedback, yet all showed increased movement performance, suggesting that immediate feedback on errors can effectively aid rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of position feedback during task-oriented upper-limb training after stroke: five-case pilot study. Molier, BI., Prange, GB., Krabben, T., et al.[2019]

A new technique for retraining reaching skills in poststroke hemiparesis patients involved temporarily magnifying errors, which showed immediate benefits in improving movement straightness during a 3-hour session with a robotic device.

Out of 10 patients, while all showed initial improvement, 3 did not retain the benefits after the training, suggesting that this method has potential but may require further refinement for consistent long-term results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Custom-designed haptic training for restoring reaching ability to individuals with poststroke hemiparesis. Patton, JL., Kovic, M., Mussa-Ivaldi, FA.[2019]

A study aimed at improving motor recovery in chronic stroke patients showed that using real-time auditory feedback during upper extremity training significantly enhances reach trajectory performance compared to practice alone.

The research involved analyzing 20 reach parameters in two groups of stroke patients, demonstrating that while both methods can modify reach trajectories, auditory feedback is essential for achieving better performance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retraining reaching in chronic stroke with real-time auditory feedback. Maulucci, RA., Eckhouse, RH.[2016]

Augmented error feedback, specifically using a gain of 2 or an offset equal to the average error, significantly accelerated motor learning in healthy adults adapting to a 30° visuomotor rotation, with learning speed nearly twice that of control groups.

The group receiving the offset feedback not only learned faster but also showed a greater reduction in error, suggesting that these techniques could be beneficial for training in robotic teleoperation or rehabilitation for individuals with movement impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visuomotor learning enhanced by augmenting instantaneous trajectory error feedback during reaching. Patton, JL., Wei, YJ., Bajaj, P., et al.[2021]

A new visual distortion training method for stroke survivors, which simulates robot-assisted feedback without the actual robot, showed promising early results in improving motor skills during a bimanual virtual reality task.

Both treatment and control groups improved after three weeks of practice, with the treatment group showing a slight advantage, suggesting that visual feedback alone can be an effective and simpler alternative for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stroke Rehabilitation with Distorted Vision Perceived as Forces. Hajissa, E., Celian, C., Thielbar, KO., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Learning, not adaptation, characterizes stroke motor recovery: evidence from kinematic changes induced by robot-assisted therapy in trained and untrained task in the same workspace. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of position feedback during task-oriented upper-limb training after stroke: five-case pilot study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Custom-designed haptic training for restoring reaching ability to individuals with poststroke hemiparesis. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Retraining reaching in chronic stroke with real-time auditory feedback. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Motor training of upper extremity with functional electrical stimulation in early stroke rehabilitation. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Visuomotor learning enhanced by augmenting instantaneous trajectory error feedback during reaching. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Stroke Rehabilitation with Distorted Vision Perceived as Forces. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Robot-Assisted Reach Training With an Active Assistant Protocol for Long-Term Upper Extremity Impairment Poststroke: A Randomized Controlled Trial. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Customized therapy using distributions of reaching errors. [2022]