CI Therapy for Stroke-related Arm Weakness

Overseen By Mary H Bowman, BS OT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Constraint-Induced Therapy (CI Therapy) for individuals with arm weakness following a stroke. The goal is to improve the use of the weaker arm and hand through specific movements and strategies that encourage its use in daily life. The therapy involves daily sessions over two weeks, focusing on motor training and sensory components. Individuals who experienced a stroke more than six months ago and can move their wrist and fingers slightly may find this trial suitable. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance rehabilitation strategies for stroke survivors.

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 prior data suggests that this method is safe for stroke-related arm weakness?

Research has shown that Constraint-Induced (CI) Therapy is a promising method for aiding stroke recovery, particularly in enhancing arm use. Studies have demonstrated that this therapy is safe and can significantly improve the use of the affected arm in stroke patients.

One study found that CI Therapy helps patients regain movement and use of their arm after a stroke, with no serious side effects reported, suggesting that most patients tolerate the treatment well. Another study supports these findings, showing that CI Therapy can improve arm function without causing harm.

Overall, available research suggests that CI Therapy, when combined with sensory elements, is a safe option for stroke recovery. The therapy aims to improve daily arm use, and evidence so far indicates its safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Grade 1 CI Therapy with Sensory Components for stroke-related arm weakness because it combines constraint-induced (CI) therapy with sensory enhancement, potentially offering a more comprehensive approach to rehabilitation. Unlike traditional therapies that focus solely on repetitive physical tasks, this treatment also stimulates sensory pathways, which may enhance neural plasticity and recovery. Moreover, the two-week intensive program could lead to faster improvements in arm function compared to standard prolonged therapies, making it a promising option for patients eager to regain mobility and independence quickly.

What evidence suggests that CI Therapy is effective for stroke-related arm weakness?

Research has shown that Constraint-Induced Movement Therapy (CI Therapy) effectively improves arm function after a stroke. Studies have found that CI Therapy enhances upper arm movement and reduces difficulties for stroke patients. Participants in these studies performed daily activities better due to the therapy. Significant improvements in the frequency and quality of the affected arm's use were observed. The therapy involves focused training and techniques to encourage using the weaker arm, leading to better recovery for those with arm weakness due to a stroke.

In this trial, all participants will receive Grade 1 CI Therapy with Sensory Components over a two-week period. ^{3 6 7 8 9}

Who Is on the Research Team?

David Morris, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Grade 1 CI Therapy +Sensory Components

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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 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) 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 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 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 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]

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]

Citations

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

Constraint-Induced Movement Therapy after Stroke - PMC Constraint-induced movement therapy (CIMT) was developed to overcome upper limb impairments after stroke and is the most investigated intervention for treating ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0003999325003600

Effectiveness of Constraint-Induced Movement Therapy ... Results. The sample size was 53 participants, with a mean age of 56±11 years and 62±76 months poststroke. Statistically significant differences were detected ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11621666/

The Effect of Constraint-Induced Movement Therapy on ... In patients with stroke-induced hemiplegia, CIMT improved upper-limb motor function, reduced upper-limb impairment, and enhanced ADL performance. No adverse ...

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

Effect of Constraint-Induced Movement Therapy on Upper ... More for You. Facial Numbness, Dysarthria, Muscle Atrophy, and Weakness in a Young Patient ... outcome and quality of life after stroke ...

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

Effects of Constraint-Induced Movement Therapy on ... The results indicate that CI therapy is a powerful treatment for improving the rehabilitation of movement of the affected upper extremity in chronic stroke ...

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

The effect and safety of constraint-induced movement ... Post-stroke motor dysfunction (PSMD) manifests as the insufficiency of motor function, including bradykinesia, ataxia, and muscle weakness, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06692569

The Effect of Modified Constraint Induced Movement ... Inclusion Criteria: Right or left-sided chronic hemiplegic patients. Onset of stroke More than six months. Age between 45 to 65 years of both genders ...

8. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05515237

Constraint-Induced Movement Therapy Plus Sensory ... Numerous studies examining the application of CI therapy with UE rehabilitation after stroke have demonstrated strong evidence for improving the amount of use ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2666337625000678

Modified constraint-induced movement therapy for lower ... mCIMT is safe and effective for stroke lower extremity rehabilitation. ... and muscle weakness, is a common complication after stroke.