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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how constraint-induced movement therapy (CI therapy) aids brain healing after a stroke. Researchers aim to understand how this treatment might prompt the brain to "rewire" itself, potentially improving motor skills. They will use advanced brain imaging to observe changes in the brain's structure during therapy. Individuals who had a stroke over six months ago and still retain some arm or hand movement might be suitable candidates. The study seeks to discover better methods for brain recovery and enhance stroke rehabilitation. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could improve stroke recovery therapies.

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 prior data suggests that this method is safe for motor rehabilitation in stroke patients?

Research has shown that CI therapy, used to aid stroke recovery, is generally safe. Studies have found it effective in improving movement, with many individuals tolerating it well. For example, one study found that combining CI therapy with regular rehabilitation improved arm movement more than standard rehab alone. Another study showed that about half of stroke patients experienced significant benefits from this therapy. While these studies focus on its effectiveness, they also suggest the treatment is safe for many individuals. No major safety issues have been reported, making it a promising option for those seeking to regain movement after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Constraint-Induced (CI) therapy for stroke rehabilitation because it takes a unique approach to motor recovery. Unlike traditional physical therapy, which often focuses on assisting the weaker limb, CI therapy encourages patients to use their affected limb by restraining the stronger one. This method aims to improve motor function and stimulate brain plasticity, which is the brain's ability to reorganize itself. By challenging the brain in this way, CI therapy has the potential to enhance recovery and improve long-term outcomes for stroke survivors.

What is the effectiveness track record for CI therapy in motor rehabilitation for stroke?

Research has shown that constraint-induced movement therapy (CI therapy) effectively improves movement in stroke survivors. One study found that CI therapy enhances movement, daily activities, and self-reported arm and hand use. Another study estimated that at least half of stroke patients could experience significant improvement from this treatment. In this trial, participants will receive either immediate or delayed CI therapy. CI therapy helps the brain "rewire" itself, forming new connections to enhance movement. This brain change occurs partly due to an increase in grey matter, which contains many nerve cells, in specific areas. Overall, CI therapy offers a promising option for those seeking to regain movement after a stroke. ^{2 3 6 7 8}

Who Is on the Research Team?

Yousef Hannawi, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4361809/

Constraint-Induced Movement Therapy after Stroke - PMC Meta-analysis showed strong evidence favoring both types of CIMT in terms of motor function, arm-hand activities and self-reported arm-hand functioning in daily ...

2. ahajournals.org ahajournals.org/doi/10.1161/01.str.30.3.586

Effects of Constraint-Induced Movement Therapy on ... It is estimated that patients amenable to substantial improvement as a result of CI therapy represent at least 50% of the total stroke population. Most of the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3724070/

Study to assess the effectiveness of modified constraint ... The purpose of this study was to assess the effectiveness of modified constraint induced movement therapy (m-CIMT) in stroke subjects.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999399901636

Constraint-induced movement therapy for motor recovery ... Conclusions: CI therapy is an efficacious treatment for chronic stroke patients, especially in terms of real world outcome.

5. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05515237

Constraint-Induced Movement Therapy Plus Sensory ... The purpose of this study is to systematically examine the feasibility of adding somatosensory components to CI Therapy protocols for patients having mild-to- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10151521/

The effect and safety of constraint-induced movement ... Our results showed that CIMT combined with conventional rehabilitation (CR) was superior to CR in improving MAL-AOU and MAL-QOM scores.

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/203876

Effect of Constraint-Induced Movement Therapy on Upper ... The CIMT group achieved a decrease of 19.5 in self-perceived hand function difficulty (Stroke Impact Scale hand domain) vs a decrease of 10.1 ...

8. uab.edu uab.edu/citherapy/images/pdf_files/Taub_UE_CIMT_RCT_ChronicStroke_Stroke06.pdf

A Placebo-Controlled Trial of Constraint-Induced ... Conclusion—The results support the efficacy of CI therapy for rehabilitating upper extremity motor function in patients with chronic stroke. (Stroke. 2006;37: ...