CI Therapy for Stroke-related Arm Weakness

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alabama at Birmingham

Disqualifiers: Cognitive impairment, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Constraint-Induced Therapy (CI Therapy) is a behavioral approach to neurorehabilitation and consists of multi-components that have been applied in a systematic method to improve the use of the limb or function addressed in the intensive treatment. CI Therapy for the more-affected upper extremity (UE) post-stroke is administered in daily treatment sessions over consecutive weekdays. Sessions include motor training with repeated, timed trials using a technique called shaping, a set of behavioral strategies known as the Transfer Package (TP) to improve the use of the more-affected hand in the life situation, and strategies to remind participants to use the more-affected UE including restraint. Robust improvements in the amount and qualify of use have been realized with stroke participants from mild-to-severe UE impairment.

Do I need to stop my current medications for the trial?

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

What data supports the effectiveness of this treatment for stroke-related arm weakness?

Research shows that Constraint-Induced Movement Therapy (CI therapy) helps improve arm use in stroke patients by encouraging the use of the affected arm and promoting brain reorganization. This therapy has been effective in increasing the use of the affected arm in daily activities, with benefits lasting up to two years. ^{1 2 3 4 5}

Is CI Therapy safe for humans?

The research does not specifically address safety concerns for CI Therapy, but it is widely used and studied for stroke rehabilitation, suggesting it is generally considered safe for humans. ^{1 6 7 8 9}

How is CI Therapy for stroke-related arm weakness different from other treatments?

CI Therapy is unique because it involves intensive use of the affected arm by restricting the movement of the unaffected arm, which encourages the brain to reorganize and improve motor function. This approach is different from traditional therapies as it focuses on overcoming learned nonuse and promoting brain plasticity through repetitive practice. ^{1 2 3 5 10}

Research Team

David Morris, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults who had a stroke at least 6 months ago and have mild difficulty using their upper limb. They must be able to move their wrist and fingers to some extent and score above a certain level on an activity log. People with severe cognitive impairment, unable to consent, or can't attend treatment sessions are excluded.

Inclusion Criteria

It has been over 6 months since my stroke.

I can move my wrist, thumb, and fingers as required.

I use my weaker arm or hand more than average.

Exclusion Criteria

I am unable to understand or answer questions about my treatment.

You score less than 24 on a test that checks your memory and thinking skills.

I cannot go to the lab for treatment.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Grade 1 CI Therapy + Sensory Components administered over a two-week period

2 weeks

Follow-up

Participants are monitored for changes in mood and quality of life at 3 months post-treatment

3 months

Treatment Details

Interventions

• Grade 1 CI Therapy +Sensory Components (Behavioural Intervention)

Trial Overview The study tests Constraint-Induced Therapy (CI Therapy) which includes intensive motor training, behavioral strategies, and restraint of the less affected hand to improve use of the more-affected arm after a stroke.

Participant Groups

Group I: Grade 1 CI Therapy + Sensory Components Experimental Treatment 1 Intervention

All participants will receive the Grade 1 CI Therapy + Sensory Components administered over a two-week period of time.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Findings from Research

Constraint-Induced Movement Therapy (CI therapy) is effective for improving limb use in patients with chronic disabilities from central nervous system injuries, including stroke, and can lead to significant functional improvements even after conventional therapy.

The therapy works by promoting brain plasticity and overcoming learned nonuse of the affected limb, and its success depends on tailoring the approach to individual patient needs and circumstances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Constraint-induced movement therapy for chronic stroke hemiparesis and other disabilities. Mark, VW., Taub, E.[2022]

Constraint-Induced Movement therapy (CI therapy) effectively improves motor function and upper extremity use in individuals with hemiparesis from chronic stroke by addressing learned nonuse and promoting cortical reorganization.

CI therapy may also benefit other conditions with similar cortical organization issues, suggesting it could be a promising new approach in neurorehabilitation for various disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved motor recovery after stroke and massive cortical reorganization following Constraint-Induced Movement therapy. Taub, E., Uswatte, G., Morris, DM.[2019]

Constraint-induced (CI) movement therapy significantly improves the use of the affected upper extremity in stroke patients by encouraging them to use their impaired arm for many hours each day over 10 to 14 days.

The therapy has shown lasting benefits, with increased arm use in daily activities persisting for up to 2 years, and patients who are likely to benefit can be identified prior to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Constraint Induced Movement Techniques To Facilitate Upper Extremity Use in Stroke Patients. Taub, E., Wolf, SL.[2016]

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) significantly improved hand function in 74% of stroke patients, while improvements in shoulder/elbow/forearm function were less pronounced, indicating that CI therapy is particularly effective for enhancing hand capabilities.

The study involved 19 patients with moderate to slight upper-extremity impairment, who underwent 5 hours of modified CI therapy daily for 10 days, demonstrating that targeted therapy can lead to meaningful functional gains in specific areas of upper extremity movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective targets for constraint-induced movement therapy for patients with upper-extremity impairment after stroke. Koyama, T., Sano, K., Tanaka, S., et al.[2016]

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 movement therapy (CI therapy) shows promise in helping stroke patients regain upper limb function, particularly for those with some movement recovery, but its success relies heavily on patient cooperation and intensive practice.

Evidence suggests that CI therapy can lead to significant changes in the brain's motor cortex, indicating that the therapy not only aids in physical recovery but also promotes cortical reorganization, which is crucial for improving motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repetitive task practice: a critical review of constraint-induced movement therapy in stroke. Wolf, SL., Blanton, S., Baer, H., 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]

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 (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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Constraint-induced movement therapy for chronic stroke hemiparesis and other disabilities. [2022]

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

Improved motor recovery after stroke and massive cortical reorganization following Constraint-Induced Movement therapy. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Constraint Induced Movement Techniques To Facilitate Upper Extremity Use in Stroke Patients. [2016]

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

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

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effective targets for constraint-induced movement therapy for patients with upper-extremity impairment after stroke. [2016]

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

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

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

Repetitive task practice: a critical review of constraint-induced movement therapy in stroke. [2019]

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

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

9. 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]

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

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