Motor Rehabilitation for Stroke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Botulinum toxin

Disqualifiers: Dementia, Severe pain, Kidney disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

31 Participants Needed

Trial Summary

What is the purpose of this trial?

Constraint-induced movement therapy (CI therapy) is a highly efficacious treatment for residual motor disability in chronic stroke. Its effectiveness is believed to be due, at least in part, to the therapy's ability to aid the brain in "rewiring itself." For example, CI therapy produces increases in the amount of grey matter (the parts of the brain where neuron cell bodies are most closely clustered) in certain areas of the human brain (Gauthier et al., 2008). The cellular and molecular mechanisms that are responsible for this increase in grey matter volume are not known, however. Thus, it is unclear how the therapy helps brains "rewire" themselves. This study aims to better understand the timecourse and cellular/molecular nature of brain changes during CI therapy. Because there is currently no way to directly measure cellular/molecular changes in the brain noninvasively, this study will infer what is happening on a microstructural level using new MRI techniques (three dimensional pictures of the brain). For example, by charting the timecourse of grey matter changes during CI therapy, and cross-comparing this to what is known about the timecourses of different cellular/molecular processes, the investigators can gain a greater understanding of what cellular processes may be responsible for increases in grey matter. The investigators will gain additional information about which cellular processes are important for rehabilitation-induced improvement by measuring larger-scale changes (e.g., amount of blood flow through different brain areas) that accompany cellular changes. The investigators are hopeful that by better understanding how CI therapy can change the brain, the effectiveness of rehabilitation can be improved upon. For example, insight into the mechanisms of rehabilitation-induced brain change may suggest particular drug targets to increase brain plasticity. This study will help us better understand how the brain repairs itself after injury.

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 are participating in other experimental trials for motor dysfunction or have received a botulinum toxin injection in the past 3 months, you would not be eligible for this study.

What data supports the effectiveness of the treatment CI therapy for motor rehabilitation after stroke?

Research shows that CI therapy, which encourages the use of a more-affected arm, significantly improves movement quality and daily use of the arm in stroke patients. Studies also indicate that this therapy leads to changes in the brain that support these improvements, making it a promising approach for stroke rehabilitation. ^{1 2 3 4 5}

Is constraint-induced movement therapy (CI therapy) safe for humans?

The research articles do not provide specific safety data for constraint-induced movement therapy (CI therapy), but they focus on its use in stroke rehabilitation and its effectiveness in improving motor function. ^{2 6 7 8 9}

How does the treatment CI therapy differ from other treatments for stroke?

CI therapy is unique because it involves intensive use of the affected arm by restricting the less affected arm, which encourages the brain to reorganize and improve motor function. This approach is different from traditional therapies as it focuses on increasing the use of the affected limb for many hours a day over a few weeks, leading to significant improvements in daily activities. ^{3 4 6 8 10}

Research Team

Yousef Hannawi, MD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for adults over 18 who had a stroke at least 6 months ago, resulting in mild to moderate hemiparesis but can still understand and participate in therapy. It's not for those with severe medical conditions, recent botulinum toxin injections, intensive post-stroke rehab, kidney issues, metallic/electronic implants incompatible with MRI, or claustrophobia.

Inclusion Criteria

I understand and can follow the treatment plan.

I had a stroke 6 months ago that caused mild to moderate weakness on one side.

I am 18 years old or older.

Exclusion Criteria

My kidney function is reduced with an eGFR below 60.

I have anemia.

I do not have severe health issues like dementia or uncontrollable pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Constraint-induced movement therapy (CI therapy) to assess changes in brain structure and motor function

2 weeks

Weekly visits for MRI and motor function assessments

Follow-up

Participants are monitored for changes in brain structure and motor function after treatment

2 weeks

1 visit (in-person) for follow-up assessments

Treatment Details

Interventions

• CI therapy

Trial Overview The study tests Constraint-induced movement therapy (CI therapy) which helps the brain 'rewire' after chronic stroke. Using advanced MRI techniques to observe changes in grey matter and blood flow will infer cellular processes behind brain reorganization during CI therapy.

Participant Groups

Group I: Immediate CI therapy Experimental Treatment 1 Intervention

Group II: Delayed CI therapy Active Control 1 Intervention

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Findings from Research

In a study involving 45 participants with chronic stroke, improvements in daily use of the affected arm (measured by the Motor Activity Log) were found to significantly enhance quality of life, while improvements in motor function did not show a similar association.

The findings highlight the importance of promoting everyday arm use in rehabilitation programs for stroke patients, suggesting that focusing on functional activities may lead to better quality of life outcomes than solely targeting motor function improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved quality of life following constraint-induced movement therapy is associated with gains in arm use, but not motor improvement. Kelly, KM., Borstad, AL., Kline, D., et al.[2023]

Constraint-induced (CI) movement therapy significantly enhances the use and quality of movement in the more-affected upper extremity of stroke patients through intensive practice over 2 to 3 weeks.

This therapy leads to substantial cortical reorganization in the brain, increasing the area responsible for movement in the affected arm, suggesting a need for a shift in traditional rehabilitation practices to incorporate this effective approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Constraint-induced movement therapy to enhance recovery after stroke. Taub, E., Morris, DM.[2019]

Constraint-Induced Movement therapy (CI therapy) has been shown to be effective in rehabilitating arm use in individuals with chronic stroke, supported by 20 years of research.

Current research is exploring additional questions about CI therapy, including its cost-effectiveness, optimal training parameters, and how different patient characteristics may influence its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Constraint-Induced Movement therapy: answers and questions after two decades of research. Taub, E., Uswatt, G.[2007]

Constraint-induced movement therapy (CI therapy) is effective in enhancing the use of the more-affected arm after a stroke, but the commonly cited restraining mitt on the less affected arm contributes less to the treatment outcomes than previously thought.

The therapy consists of various treatment components beyond just restraint, highlighting the importance of understanding the full protocol to appreciate its effectiveness in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Constraint-induced movement therapy: characterizing the intervention protocol. Morris, DM., Taub, E., Mark, VW.[2022]

In a study involving 32 stroke patients, constraint-induced movement therapy (CIT) significantly improved motor function, functional independence, and quality of life compared to a control intervention that also involved hand restraint.

CIT combined intensive training of the affected limb with restraint of the less affected limb, leading to better outcomes in daily activities and overall health-related quality of life after just 3 weeks of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Constraint-induced therapy versus dose-matched control intervention to improve motor ability, basic/extended daily functions, and quality of life in stroke. Lin, KC., Wu, CY., Liu, JS., et al.[2019]

In a placebo-controlled trial involving patients with chronic stroke (average of 4.5 years post-stroke), Constraint-Induced Movement therapy (CI therapy) led to significant and lasting improvements in the use of the more affected arm, as measured by the Wolf Motor Function Test and Motor Activity Log (P<0.0001).

The placebo group, which engaged in physical fitness and cognitive exercises, showed no significant changes, highlighting the specific efficacy of CI therapy in enhancing upper extremity motor function after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A placebo-controlled trial of constraint-induced movement therapy for upper extremity after stroke. Taub, E., Uswatte, G., King, DK., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Improved quality of life following constraint-induced movement therapy is associated with gains in arm use, but not motor improvement. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Constraint-induced movement therapy in stroke rehabilitation: perspectives on future clinical applications. [2022]

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

Constraint-induced movement therapy to enhance recovery after stroke. [2019]

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

Constraint-Induced Movement therapy: answers and questions after two decades of research. [2007]

5. England pubmed.ncbi.nlm.nih.gov

Functional MRI and motor behavioral changes obtained with constraint-induced movement therapy in chronic stroke. [2016]

6. Italy pubmed.ncbi.nlm.nih.gov

Constraint-induced movement therapy: characterizing the intervention protocol. [2022]

7. Austria pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of constraint-induced movement therapy after stroke. [2019]

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

Constraint-induced therapy versus dose-matched control intervention to improve motor ability, basic/extended daily functions, and quality of life in stroke. [2019]

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

A placebo-controlled trial of constraint-induced movement therapy for upper extremity after stroke. [2022]

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

Pertinence of Constraint-Induced Movement Therapy in Neurological Rehabilitation: A Scoping Review. [2023]