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

Trial Summary

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 data supports the effectiveness of the treatment Constraint-Induced Movement Therapy Plus Sensory Components for stroke?

Research shows that Constraint-Induced Movement Therapy (CIMT) can improve the use of the affected arm and enhance quality of life for stroke patients. Studies have found positive effects on motor function and daily arm use, although the exact reasons for these improvements are not fully understood. ^{1 2 3 4 5}

Is CI Therapy safe for humans?

The research articles do not provide specific safety data for CI Therapy, but they do not report any safety concerns, suggesting it is generally considered safe for use in humans. ^{1 2 6 7 8}

How is the treatment CI Therapy + Sensory Training for Stroke different from other treatments for stroke?

CI Therapy + Sensory Training is unique because it combines Constraint-Induced Movement Therapy, which helps improve movement by encouraging use of the affected limb, with sensory training to enhance recovery. This approach not only addresses physical movement but also aims to reorganize the brain's structure to improve function, which is different from standard physical therapies that may not focus on brain plasticity. ^{1 2 6 8 9}

What is the purpose of this trial?

Constraint-Induced Movement Therapy or CI Therapy is a form of treatment that systematically employs the application of selected behavioral techniques delivered in intensive treatment over consecutive day with the following strategies utilized: behavioral strategies are implemented to improve the use of the more- affected limb in life situation called a Transfer Package (TP), motor training using a technique called shaping to make progress in successive approximations, repetitive, task oriented training, and strategies to encourage or constrain participants to use the more-affected extremity including restraint of the less-affected arm in the upper extremity (UE) protocol. Numerous studies examining the application of CI therapy with UE rehabilitation after stroke have demonstrated strong evidence for improving the amount of use and the quality of the more-affected UE functional use in the participant's daily life situation. CI Therapy studies with adults, to date, have explored intensive treatment for participants with a range from mild-to-severe motor impairment following stroke with noted motor deficits and limited use of the more-affected arm and hand in everyday activities. Each CI Therapy protocol was designed for the level of impairment demonstrated by participants recruited for the study. However, often following stroke, patients not only have motor deficits but somatosensory impairments as well. The somatosensory issues have not, as yet, been systematically measured and trained in CI Therapy protocols with adults and represent an understudied area of stroke recovery. We hypothesize that participants with mild-to-severe motor impairment and UE functional use deficits can benefit from CI therapy protocols that include somatosensory measurement and training components substituted for portions of motor training without loss in outcome measure gains. Further, we hypothesize that adults can improve somatosensory outcomes as a result of a combined CI therapy plus somatosensory component protocol.

Research Team

David Morris, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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 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) 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) 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]

References

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

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

2. United States 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. [2021]

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

Improvement after constraint-induced movement therapy: recovery of normal motor control or task-specific compensation? [2022]

4. England pubmed.ncbi.nlm.nih.gov

Short- and long-term outcome of constraint-induced movement therapy after stroke: a randomized controlled feasibility trial. [2016]

5. 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]

6. 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]

7. Italy pubmed.ncbi.nlm.nih.gov

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

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

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

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

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