CI Therapy + Sensory Training for Stroke

Overseen By Mary Bowman, BS OT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Cognitive impairment, Inability to travel, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 2-3 weeks

15 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 Movement Therapy (CI Therapy) combined with sensory training for stroke survivors. The goal is to improve the use and quality of movement in the arm and hand most affected by the stroke, while also addressing sensory issues. Participants will undergo an intensive therapy program over 2-3 weeks to determine if adding sensory training enhances recovery without hindering motor skill progress. Ideal participants are those who had a stroke at least six months ago and have moderate to severe movement issues in their affected arm but can still perform basic movements like shoulder, elbow, or wrist motions. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance 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. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for stroke patients?

Research shows that Constraint-Induced Movement Therapy (CIMT), like the one used in this trial, is generally safe for stroke patients. Studies have found that combining CIMT with other rehabilitation methods improves movement with only minor side effects. Specifically, no major impacts on grip strength, sensation, pain, or overall quality of life occur after the therapy.

Another study found that CIMT helps improve hand function, indicating the therapy is effective and well-tolerated. Importantly, when CIMT was used in different ways, such as with other therapies, improvements occurred without major side effects. This suggests that adding sensory elements, as in this trial, should be safe. However, since the sensory part is new, its specific effects are still being studied.

Overall, past research considers CIMT safe. The addition of sensory training is being explored to see if it offers more benefits without adding new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Constraint-Induced Movement Therapy Plus Sensory Components (CI Therapy + Sensory Components) is unique because it combines physical rehabilitation with sensory training, which is not typical in standard stroke recovery methods. Standard treatments often focus solely on physical exercises or occupational therapy to regain movement. However, CI Therapy + Sensory Components adds sensory retraining, which helps patients not only move better but also feel and respond more accurately to touch and other stimuli. Researchers are excited because this comprehensive approach could enhance brain plasticity, leading to faster and more effective recovery after a stroke.

What evidence suggests that CI Therapy plus sensory components is effective for stroke recovery?

Research has shown that Constraint-Induced Movement Therapy (CI Therapy) can improve arm and hand function after a stroke. Studies have found that this therapy encourages patients to use their affected arm more in everyday activities, leading to better movement quality. For instance, one study discovered that patients who underwent CI Therapy had much better arm function than those who did not. In this trial, all participants will receive CI Therapy with added sensory components. While traditional CI Therapy mainly focuses on improving movement, adding sensory training aims to address issues with feeling and touch, which have not been studied as much. Early signs suggest that including sensory training might boost overall recovery for stroke patients. ^{1 5 6 7 8}

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've had a stroke at least 6 months ago and have mild-to-severe difficulty moving their arm but can still do some basic movements. They should be able to use the affected arm a little in daily life, as shown by specific test scores.

Inclusion Criteria

I can move my shoulder, elbow, wrist, fingers, or thumb a little.

My use of my weaker arm or hand scores less than 2.5 on a specific test.

It has been over 6 months since my stroke.

Exclusion Criteria

I am unable to understand or answer specific health questions or give informed consent.

I cannot go to the lab for treatment.

You have a score less than 24 on a brain function test called the Mini Mental State Exam.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CI therapy plus somatosensory training components for the more-affected upper extremity for 2-3 weeks, depending on the level of UE impairment severity.

2-3 weeks

5 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including the Motor Activity Log and other measures.

3 months

Follow-up assessments conducted via telephone

What Are the Treatments Tested in This Trial?

Interventions

• Constraint-Induced Movement Therapy Plus Sensory Components

Trial Overview The study tests Constraint-Induced Movement Therapy with added sensory training on people after a stroke. It involves intensive behavioral techniques, motor training, tasks that encourage using the weaker arm, and strategies to improve its everyday use.

How Is the Trial Designed?

Group I: Grade 2-5 CI Therapy + Sensory Components Experimental Treatment 1 Intervention

All participants will receive CI Therapy + Sensory Components administered over the specific time frame of 2-3 weeks.

Constraint-Induced Movement Therapy Plus Sensory Components is already approved in United States, European Union for the following indications:

Approved in United States as Constraint-Induced Movement Therapy for:

• Stroke rehabilitation
• Upper extremity motor impairment
• Hemiparesis

Approved in European Union as Constraint-Induced Movement Therapy for:

• Stroke rehabilitation
• Upper extremity motor impairment
• Hemiparesis

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

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) 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) 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 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 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 58 stroke patients, lower limb constraint-induced movement therapy (CIMT) focusing on 600 repetitions of tasks was found to be more effective than a protocol based on 3 hours of practice, particularly in reducing knee extensor spasticity and improving exertion levels.

The results suggest that a higher number of task repetitions may lead to better rehabilitation outcomes in motor function after stroke, highlighting the importance of task repetition in stroke recovery therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Two Different Modes of Task Practice during Lower Limb Constraint-Induced Movement Therapy in People with Stroke: A Randomized Clinical Trial. Abdullahi, A., Aliyu, NU., Useh, U., et al.[2021]

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 proof-of-concept study involving 10 chronic stroke patients, constraint-induced movement therapy (CIMT) led to significant functional improvements in arm use, as measured by the Action Research Arm Test (ARAT), over a 2-week period.

The study suggests that the improvements observed after CIMT may be due to compensatory strategies rather than actual recovery of normal motor control, highlighting the need for future research to include kinematic analyses alongside traditional clinical measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement after constraint-induced movement therapy: recovery of normal motor control or task-specific compensation? Kitago, T., Liang, J., Huang, VS., et al.[2022]

Constraint-induced movement therapy (CIMT) significantly improved motor function in stroke patients in the short term, with the CIMT group showing faster performance and greater functional ability compared to traditional rehabilitation.

While CIMT was effective immediately after treatment, the long-term benefits were not sustained, as the control group continued to improve, leading to no significant differences between the groups at the six-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short- and long-term outcome of constraint-induced movement therapy after stroke: a randomized controlled feasibility trial. Dahl, AE., Askim, T., Stock, R., et al.[2016]

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/S2666337621000433

Effectiveness of modified constraint-induced movement ... The outcome of this evaluation support that mCIMT significantly improves the upper limb function of stroke patients. Moreover, group mCIMT modality and TR ( ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40313194/

Effectiveness of modified constraint-induced movement ... Conclusion: Modified constraint-induced movement therapy improves upper limb function in the acute and sub-acute stages of stroke recovery ...

4. thelancet.com thelancet.com/journals/laneur/article/PIIS1474-4422(14)70160-7/abstract

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

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

Effect of Constraint-Induced Movement Therapy on Upper ... We hypothesized that patients who received CIMT up to 9 months following stroke would improve upper extremity function compared with patients ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06910904

CONSTRAINT-INDUCED MOVEMENT THERAPY (CIMT) ... This study aimed to compare the effects of Constraint-Induced Movement Therapy (CIMT) and Mirror Therapy (MT) on hand function and spasticity in individuals ...

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

Modified constraint-induced movement therapy for lower ... Studies show that mCIMT improves motor function, functional mobility, balance, lower limb strength, weight-bearing, and walking ability with minor side effects.