An interventional study of Exercise and Home program in Stroke, sponsored by Gazi University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-07-11.
Sponsored by Gazi University · Not applicable, Interventional, and Treatment
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.
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 18 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Gazi University is the lead sponsor of 548 studies on the registry; 104 are open to participants now.
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Exclusion Criteria:
The group will receive modified-Constraint Induced Movement Therapy via telerehabilitation and a home exercise program.
Other: Exercise · Other: Home program
The group only will be given a home exercise program.
Other: Home program
M-CIMT-based telerehabilitation will be implemented.
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.
Upper extremity motor ability-Baseline
Wolf Motor Function Test
Time frame: Assessment will be conducted before the intervention.
Upper extremity motor ability-Post intervention
Wolf Motor Function Test
Time frame: Assessment will be conducted immediately after the intervention.
Upper extremity motor function-Baseline
The Fugl-Meyer Assessment of the Upper Extremity
Time frame: Assessment will be conducted before the intervention.
Upper extremity motor function-Post intervention
The Fugl-Meyer Assessment of the Upper Extremity
Time frame: 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.
Time frame: 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.
Time frame: Assessment will be conducted immediately after the intervention.
Voluntary movement and mobility-Baseline
Stroke Rehabilitation Assessment of Movement (STREAM)
Time frame: Assessment will be conducted before the intervention.
Voluntary movement and mobility-Post intervention
Stroke Rehabilitation Assessment of Movement (STREAM)
Time frame: Assessment will be conducted immediately after the intervention.
Isometric hand strength-Baseline
J-Tech™
Time frame: Assessment will be conducted before the intervention.
Isometric hand strength-Post intervention
J-Tech™
Time frame: Assessment will be conducted immediately after the intervention.
Isometric pinch strength-Baseline
Baseline® pinch meter
Time frame: Assessment will be conducted before the intervention.
Isometric pinch strength-Post intervention
Baseline® pinch meter
Time frame: Assessment will be conducted immediately after the intervention.
manual dexterity performance-Baseline
nine-hole peg test (9-HTP)
Time frame: Assessment will be conducted before the intervention.
manual dexterity performance-Post intervention
nine-hole peg test (9-HTP)
Time frame: Assessment will be conducted immediately after the intervention.
level of independence in activities of daily living-Baseline
Functional Independence Measure
Time frame: Assessment will be conducted before the intervention.
level of independence in activities of daily living-Post intervention
Functional Independence Measure
Time frame: Assessment will be conducted immediately after the intervention.
Plan to share: No — There is no plan to make IPD data but when the statistical analysis of all data is made, all results will be shared.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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