Effect of mCIMT on Upper Extremity Functions of Stroke Patients With Right/Left Hemiplegia

Study Overview
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Brief Summary
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The investigators aimed To analyze effect of modified constraint induced movement therapy on upper extremity functions and quality of life of subacute and chronic phase stroke patients with right/left hemisphere damage. A total of 40 patients (20 patients with right hemiplegia and 20 patients with left hemiplegia) were enrolled in our prospective, randomized and controlled trial. Patients were randomized in to three groups. The first group consists of 10 right hemiplegia patients and the second group consists of 10 left hemiplegia patients. First and second group of patients had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake. Patients were examined before treatment, just after treatment and 3 months after treatment using Box-Block Test, cubes lined, card turned and object gripped in 30 seconds, time it takes to grip and carry a water filled glass to their mouth and putting it back, Motor Activity Log (MAL), Stroke Impact Scale, Fugl-Meyer Motor Assessment Scale.

Detailed Description
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For the rehabilitation of the paretic upper extremity, the use of constraint induced movement therapy and the use of modified constraint induced movement therapy are the most effective treatment strategies. The investigators aimed To analyze effect of modified constraint induced movement therapy on upper extremity functions and quality of life of subacute and chronic phase stroke patients with right/left hemisphere damage. A total of 40 patients (20 patients with right hemiplegia and 20 patients with left hemiplegia) were enrolled in our prospective, randomized and controlled trial. Patients were randomized in to three groups. The first group consists of 10 right hemiplegia patients and the second group consists of 10 left hemiplegia patients. First and second group of patients had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake. 10 patients with right hemiplegia and 10 patients with left hemiplegia formed the control group and these patients were in line for inpatient rehabilitation programme. Patients were examined before treatment, just after treatment and 3 months after treatment using Box-Block Test, cubes lined, card turned and object gripped in 30 seconds, time it takes to grip and carry a water filled glass to their mouth and putting it back, Motor Activity Log (MAL), Stroke Impact Scale, Fugl-Meyer Motor Assessment Scale. Wilcoxon Signed Ranks test and Friedman test were used for intragroup comparison of data and Kruskal-Wallis test was used to compare data between groups.

Official Title
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Effect of Modified Constraint Induced Movement Therapy on Upper Extremity Functions of Stroke Patients With Right/Left Hemisphere Damage: Single Blind Randomized Controlled Trial

Conditions
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Stroke Patients

Intervention / Treatment
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* Other: Modified Constraint Induced Movement Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in subacute and chronic period (3 months after stroke) Modified Ashworth scale in the hemiplegic arm with 3 or more spasticity No pain in the hemiplegic arm MMSE 20 and above Without major medical problems No previous stroke history Adequate stability to walk when healthy arm is immobilized Active 20 degrees wrist extension and 10 degrees interphalangeal and metacarpophalangeal extension (these movements should be repeated 3 times in 1 minute) Exclusion Criteria: Bilateral stroke or brainstem affected Active 20-degree wrist extension and 10-degree interphalangeal and metacarpophalangeal extension Global aphasia or cognitive disorders that may affect understanding of test instructions Patients with major medical problems that may affect participation Existence of neglect

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: left hemiplegia<br>Patients in the left hemiplegia group had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake | Other: Modified Constraint Induced Movement Therapy<br>* constraint-induced movement therapy (CIMT) is characterized by the restraint of the less effected upper limb accompanied by the shaping and repetitive task-oriented training of more affected upper extremity.<br>|
| Experimental: right hemiplegia<br>Patients in the right hemiplegia group had 10 sessions of constraint induced movement therapy as groups of 4, 5 days a week. Each patient had modified constraint induced movement therapy 1 hour a day with professional support and performed home program by themselves 3 hours a day. Patients' less affected hands were limited by the help of a glove %50 of the time they were awake | Other: Modified Constraint Induced Movement Therapy<br>* constraint-induced movement therapy (CIMT) is characterized by the restraint of the less effected upper limb accompanied by the shaping and repetitive task-oriented training of more affected upper extremity.<br>|
| No Intervention: control<br>10 patients with right hemiplegia and 10 patients with left hemiplegia formed the control group and these patients were in line for inpatient rehabilitation programme. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Activity Log | Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement. | Patients were examined at baseline | 
| Motor Activity Log | Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement. | Patients were examined 2 weeks after baseline | 
| Motor Activity Log | Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement. | Patients were examined 3 months after baseline | 
| Fugl-Meyer Motor Assessment Scale | The Fugl-Meyer Motor Rating Scale, which assesses strength, reflexes and coordination, reflects the stages of motor development. In the evaluation, each item is scored over 2 points. In the upper extremity assessment, 53-66 points are considered as full capacity, 48-52 points are defined as capacity, 32-47 points are considered as limited capacity, and 31 points are considered as under-capacity. | Patients were examined at baseline | 
| Fugl-Meyer Motor Assessment Scale | The Fugl-Meyer Motor Rating Scale, which assesses strength, reflexes and coordination, reflects the stages of motor development. In the evaluation, each item is scored over 2 points. In the upper extremity assessment, 53-66 points are considered as full capacity, 48-52 points are defined as capacity, 32-47 points are considered as limited capacity, and 31 points are considered as under-capacity. | Patients were examined 2 weeks after baseline | 
| Fugl-Meyer Motor Assessment Scale | The Fugl-Meyer Motor Rating Scale, which assesses strength, reflexes and coordination, reflects the stages of motor development. In the evaluation, each item is scored over 2 points. In the upper extremity assessment, 53-66 points are considered as full capacity, 48-52 points are defined as capacity, 32-47 points are considered as limited capacity, and 31 points are considered as under-capacity. | Patients were examined 3 months after baseline | 
| Box-Block Test | Box-Block Test | Patients were examined at baseline | 
| Box-Block Test | Box-Block Test | Patients were examined 2 weeks after baseline | 
| Box-Block Test | Box-Block Test | Patients were examined 3 months after baseline | 
| exercise assessment parameters-cubes lined | cubes lined in 30 seconds | Patients were examined at baseline | 
| exercise assessment parameters-cubes lined | cubes lined in 30 seconds | Patients were examined 2 weeks after baseline | 
| exercise assessment parameters-cubes lined | cubes lined in 30 seconds | Patients were examined 3 months after baseline | 
| exercise assessment parameters-card turned | card turned in 30 seconds | Patients were examined at baseline | 
| exercise assessment parameters-card turned | card turned in 30 seconds | Patients were examined 2 weeks after baseline | 
| exercise assessment parameters-card turned | card turned in 30 seconds | Patients were examined 3 months after baseline | 
| exercise assessment parameters-object gripped | object gripped in 30 seconds | Patients were examined at baseline | 
| exercise assessment parameters-object gripped | object gripped in 30 seconds | Patients were examined 2 weeks after baseline | 
| exercise assessment parameters-object gripped | object gripped in 30 seconds | Patients were examined 3 months after baseline | 
| exercise assessment parameters-water | time it takes to grip and carry a water filled glass to their mouth and putting it back | Patients were examined at baseline | 
| exercise assessment parameters-water | time it takes to grip and carry a water filled glass to their mouth and putting it back | Patients were examined 2 weeks after baseline | 
| exercise assessment parameters-water | time it takes to grip and carry a water filled glass to their mouth and putting it back | Patients were examined 3 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke Impact Scale | Stroke Impact Scale 3,0; The aim of the study is to evaluate the perception of the quality of life after stroke by the patients themselves or their caregivers. It is a stroke-specific, patient-centered quality of life measure. It consists of 8 subsections and 59 questions. Each question is scored by evaluating the difficulty experienced in the last week on a 5-point scale. It also includes the assessment of post-stroke recovery perception with a visual analog scale of 0-100 points (0: no improvement, 100: complete recovery) | Patients were examined at baseline | 
| Stroke Impact Scale | Stroke Impact Scale 3,0; The aim of the study is to evaluate the perception of the quality of life after stroke by the patients themselves or their caregivers. It is a stroke-specific, patient-centered quality of life measure. It consists of 8 subsections and 59 questions. Each question is scored by evaluating the difficulty experienced in the last week on a 5-point scale. It also includes the assessment of post-stroke recovery perception with a visual analog scale of 0-100 points (0: no improvement, 100: complete recovery) | Patients were examined 2 weeks after baseline | 
| Stroke Impact Scale | Stroke Impact Scale 3,0; The aim of the study is to evaluate the perception of the quality of life after stroke by the patients themselves or their caregivers. It is a stroke-specific, patient-centered quality of life measure. It consists of 8 subsections and 59 questions. Each question is scored by evaluating the difficulty experienced in the last week on a 5-point scale. It also includes the assessment of post-stroke recovery perception with a visual analog scale of 0-100 points (0: no improvement, 100: complete recovery) | Patients were examined 3 months after baseline |