The Effectiveness of Telerehabilitation in Stroke Patients

Study Overview
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Brief Summary
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Stroke, according to the definition of the World Health Organization (WHO); It is a syndrome characterized by a rapid settlement of signs and symptoms of focal loss of cerebral function without a cause other than vascular causes. As it is known, it is important for patients to regain functional skills in the upper extremities after stroke. Modified-Constraint Induced Movement Therapy (m-CIMT) is a versatile neurorehabilitation technique that aims to improve motor function in the hemiparetic upper extremity and increase its use in daily life activities. However, as in the Covid-19 pandemic, patients cannot always reach rehabilitation services. In such cases, telerehabilitation is a treatment option. There are a limited number of studies in which m-CIMT is applied according to the principle of telerehabilitation, which has become a necessity, especially due to the Covid-19 pandemic. Therefore, the aim of this study is to examine the effects of m-CIMT on upper extremity motor functions in stroke patients.

Detailed Description
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This study is a randomized controlled study. The patients will be randomly divided into two groups as exercise and control. Patients in both groups will be given lower-upper extremity exercises and gait training exercises selected according to the Bobath approach as a home program consisting of 10 exercises to be applied 5 days a week for 3 weeks. All patients will perform the same exercises. In addition, the exercise group will receive Modified-Constraint Induced Movement Therapy (m-CIMT) based telerehabilitation via video conferencing 5 days a week for 3 weeks. Patients in the m-CIMT group will be asked to restrict the movements of their less affected hands by using mitt for 5 hours a day/ 5 days a week for 3 weeks while the patients are awake. Evaluations for both groups will be made by a physiotherapist blinded to the study twice, at the beginning and 3 weeks later. As outcome measures functional performance, hand strength, activities of daily living and quality of life will be evaluated.

Official Title
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The Effectiveness of Modified-Constraint Induced Movement Therapy Based Telerehabilitation in Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Other: Exercise
* Other: Home program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 years of age Being diagnosed with stroke for the first time by a doctor Having been diagnosed with stroke at least 1 month ago Mini-Mental Test Score more than or equal 24 In the upper extremities; Starting from the angle of full flexion, wrist extension of at least 20° or more, thumb extension or abduction of at least 10°, minimum extension of all other fingers at the metacarpophalangeal and interphalangeal joints Having less than 2.5 points in the pre-treatment evaluation from both parts of MAG-28 Being able to stand for 2 minutes without any help by using the upper extremity as a support tool when necessary. Absence of severe pain to affect the treatment Absence of severe spasticity to affect the treatment (spasticity in any joint of the upper extremity ≤ 2 according to the Modified Ashworth Scale) Exclusion Criteria: Any orthopedic, vision, hearing or perception problems that may affect the research results Having an additional neurological, cardiovascular, pulmonary or hormonal disorder that would prevent participation in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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
Interventional Model Description: Two groups as exercise group and control group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Group<br>The group will receive modified-Constraint Induced Movement Therapy via telerehabilitation and a home exercise program. | Other: Exercise<br>* M-CIMT-based telerehabilitation will be implemented.<br>Other: Home program<br>* Lower and upper extremity exercises and gait training exercises selected according to the Bobath approach will be given as a home program consisting of 10 same exercises.<br>|
| Active Comparator: Control group<br>The group only will be given a home exercise program. | Other: Home program<br>* Lower and upper extremity exercises and gait training exercises selected according to the Bobath approach will be given as a home program consisting of 10 same exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper extremity motor ability-Baseline | Wolf Motor Function Test | Assessment will be conducted before the intervention. | 
| Upper extremity motor ability-Post intervention | Wolf Motor Function Test | Assessment will be conducted immediately after the intervention. | 
| Upper extremity motor function-Baseline | The Fugl-Meyer Assessment of the Upper Extremity | Assessment will be conducted before the intervention. | 
| Upper extremity motor function-Post intervention | The Fugl-Meyer Assessment of the Upper Extremity | Assessment will be conducted immediately after the intervention. | 
| Activities of daily living related to the upper extremity-Baseline | Motor Activity Log-28 (MAL-28) The minimum score that can be obtained from this scale is 0, and the maximum score is 5. Higher scores mean that the level of use and quality of use is better. | Assessment will be conducted before the intervention. | 
| Activities of daily living related to the upper extremity-Post intervention | Motor Activity Log-28 (MAL-28) The minimum score that can be obtained from this scale is 0, and the maximum score is 5. Higher scores mean that the level of use and quality of use is better. | Assessment will be conducted immediately after the intervention. | 
| Voluntary movement and mobility-Baseline | Stroke Rehabilitation Assessment of Movement (STREAM) | Assessment will be conducted before the intervention. | 
| Voluntary movement and mobility-Post intervention | Stroke Rehabilitation Assessment of Movement (STREAM) | Assessment will be conducted immediately after the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isometric hand strength-Baseline | J-Tech™ | Assessment will be conducted before the intervention. | 
| Isometric hand strength-Post intervention | J-Tech™ | Assessment will be conducted immediately after the intervention. | 
| Isometric pinch strength-Baseline | Baseline® pinch meter | Assessment will be conducted before the intervention. | 
| Isometric pinch strength-Post intervention | Baseline® pinch meter | Assessment will be conducted immediately after the intervention. | 
| manual dexterity performance-Baseline | nine-hole peg test (9-HTP) | Assessment will be conducted before the intervention. | 
| manual dexterity performance-Post intervention | nine-hole peg test (9-HTP) | Assessment will be conducted immediately after the intervention. | 
| level of independence in activities of daily living-Baseline | Functional Independence Measure | Assessment will be conducted before the intervention. | 
| level of independence in activities of daily living-Post intervention | Functional Independence Measure | Assessment will be conducted immediately after the intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Telerehabilitation, modified-Constraint Induced Movement Therapy, Upper Extremity