What side effects are associated with this type of intervention?

Common treatments for stroke, particularly those involving upper limb neurorehabilitation such as customized reaching exercise programs and error-based learning, generally have minimal side effects. These therapies focus on improving motor function through repetitive, task-specific exercises. Potential side effects may include muscle soreness, fatigue, and temporary increases in spasticity or discomfort due to the physical demands of the exercises. However, these side effects are typically mild and transient. It is important for patients to be monitored by healthcare professionals to ensure exercises are performed correctly and to adjust the program as needed to minimize any adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for stroke, primarily focusing on acute management and prevention of recurrent strokes. These include thrombolytic agents like alteplase (tPA) for acute ischemic stroke and anticoagulants for secondary prevention. However, for motor function rehabilitation, which is similar to the Customized Reaching Exercise Program (Error-Based Learning), there are no specific FDA-approved drugs. Instead, rehabilitation often involves physical therapy, occupational therapy, and emerging techniques like transcranial magnetic stimulation (TMS), which has shown promise but requires further study before widespread clinical use.

What other types of research exist?

Promising, novel alternatives to the Customized Reaching Exercise Program for stroke patients include: 1) Virtual Reality (VR) Therapy, which uses immersive environments to enhance motor learning and engagement; 2) Robotics-Assisted Therapy, employing robotic devices to aid in repetitive, precise movements; 3) Mirror Therapy, which uses the reflection of the unaffected limb to stimulate brain plasticity; 4) Non-Invasive Brain Stimulation (NIBS), such as Transcranial Magnetic Stimulation (TMS) and Transcranial Direct Current Stimulation (tDCS), to enhance neural connectivity and recovery; and 5) Constraint-Induced Movement Therapy (CIMT), which encourages the use of the affected limb by restricting the unaffected limb.

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Behavioural Intervention

Error-enhanced Learning for Stroke Recovery

N/A

Recruiting

Led By James Patton, PhD

Research Sponsored by Shirley Ryan AbilityLab

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic stroke (8+ months post stroke event) with primary motor cortex involvement

Hemiparesis

Must not have

Severe current medical problems

Bilateral paresis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves physical exercises tailored to each participant's abilities and error patterns rather than medication or invasive procedures, side effects are minimal but may include muscle soreness or fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have weakness on one side of my body.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe health issues right now.

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I have weakness in both sides of my body.

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I have severe difficulty sensing body position and movement.

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I do not have vision problems that stop me from seeing things to my side.

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I have had multiple strokes or have several areas affected by stroke.

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I cannot stay in certain positions for tests.

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I do not have speech, thinking, or mood problems that would affect my participation.

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My severe muscle stiffness hinders my movement.

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I have other neurological conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment2 Interventions

Group II: Group 1Experimental Treatment2 Interventions

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common stroke treatments, particularly those involving neurorehabilitation like the Customized Reaching Exercise Program (Error-Based Learning), focus on enhancing neuroplasticity through task-specific training and motor learning principles. These methods aim to help the brain form new neural connections, which is essential for recovering motor functions and improving daily activity performance. By targeting specific movement errors, customized exercises can lead to more effective rehabilitation outcomes, making a significant difference in the recovery process for stroke patients.

Time to reconcile research findings and clinical practice on upper limb neurorehabilitation.Are they really motor learning therapies? A scoping review of evidence-based, task-focused models of upper limb therapy for children with unilateral cerebral palsy.