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IRCT20140222016680N6 IRCT 2020-04-10 Iran University of Medical Sciences comparison of three neurological rehabilitation approaches on the function of upper extremity in chronic post stroke hemiparesis patients comparison of three neurological rehabilitation approaches on the function of upper extremity in chronic post stroke hemiparesis patients 2020-02-20 anticipated 24 Complete https://irct.ir/trial/44630 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is an experimental and double-blind clinical trial. َAfter finding patients as cases in hand or simple non probable which have inclusion criteria people as absolute random will be divided into three groups using random sealed envelopes. They will be selected randomly by a person who is unaware of the groups. Random blocks (permuted block randomization) with four blocks will be used for randomization. According to the sample size of 24, six blocks will be generated using the online site (www.sealedenvelope.com). For concealment in the randomization process, unique code will be used on each envelope with the type of training specified inside, Blinding description: In this study, the participants are blind ( each 3 groups will be recieve common task oriented exercises). Assessor who evaluates outcome measures is blind to the groups and kind of treatment. Additionally, data analyzer will be unaware of intervention type and assessments. N/A stroke. Intervention 1: Intervention group1: Participants will receive 30 minute "task oriented training" and 30 minute "Brunstrom training" for 12 sessions (3 session per week). Under supervision of a therapist. patients will receive 14 task oriented activity and 7 Brunstrom training. ٍEach exercise depending on the conditions, will repeat 10- 20 times and will take 2-5 minutes. Required equipment consist of ball, towel, pitcher and mug, shopping bag, button and soda can. Intervention 2: Intervention group2: Participants will receive 30 minute "task oriented training" and 30 minute "Bobath training" for 12 sessions (3 session per week). Under supervision of a therapist, patients will recieve 14 task oriented activity and 7 Bobath training. Each execise depending on the conditions will repeat 10-20 times and will take 2-5 minutes. Required equipment consisit of ball and mat and bed. Intervention 3: Control group: Participants will receive 60 minute "task oriented training" for 12 sessions (3 session per week). Under supervision of a therapist, patients will recieve 14 task oriented activity. Each exercise depending on the conditions will repeat 10-20 times and will take 2-5 minutes. Required equipments consist of ball, towel, pitch and mug, shopping bag, button and soda can. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is We need more time to decide.
public Shohreh Noorizadeh Dehkordi
School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 7124 noorizadeh.sh@iums.ac.ir Iran University of Medical Sciences scientific Shohreh Noorizadeh Dehkordi
School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 7124 noorizadeh.sh@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 1. Having first unilateral hemiparesis following stroke. 2. confirming stroke by computerized tomography (CT) or Magnetic Resonance Imaging (MRI). 3. Having a stroke for 2 to 12 months ago. 4. Having age range between 45 to 70. 5. Ability to comprehend simple instructions (Score above 20 base on "Mini-Mental State Examination"). 6. Score above 3 base on hand motor recovery stages of Brunnstrom approach. 7. Spasticity score of the elbow flexors below 2 base on the "Modified Ashworth Scale". 8. Depression score above 8 base on the "Geriatric Depression Scale". 9. During the study, they are not involved in other rehabilitation programs in upper limbs. 45 years 70 years Both 1. Having previous injury, disease, or contracture in the involved upper extremity 2. Having severe shoulder pain. 3. No sitting balance 4. Having any comorbid neurological disease or conditions such as Multiple Sclerosis, Parkinson Disease, Spinal Cord Injury, Traumatic Brain Injuries, Brain Tumor, Epilepsy or Dementia. 5. Having unilateral neglect. G81.1 Spastic hemiplegia Rehabilitation Rehabilitation Rehabilitation Intervention group1: Participants will receive 30 minute "task oriented training" and 30 minute "Brunstrom training" for 12 sessions (3 session per week). Under supervision of a therapist. patients will receive 14 task oriented activity and 7 Brunstrom training. ٍEach exercise depending on the conditions, will repeat 10- 20 times and will take 2-5 minutes. Required equipment consist of ball, towel, pitcher and mug, shopping bag, button and soda can. Intervention group2: Participants will receive 30 minute "task oriented training" and 30 minute "Bobath training" for 12 sessions (3 session per week). Under supervision of a therapist, patients will recieve 14 task oriented activity and 7 Bobath training. Each execise depending on the conditions will repeat 10-20 times and will take 2-5 minutes. Required equipment consisit of ball and mat and bed. Control group: Participants will receive 60 minute "task oriented training" for 12 sessions (3 session per week). Under supervision of a therapist, patients will recieve 14 task oriented activity. Each exercise depending on the conditions will repeat 10-20 times and will take 2-5 minutes. Required equipments consist of ball, towel, pitch and mug, shopping bag, button and soda can. Motor function in the "Wolf Motor Function Test" and the "Fugl Meyer Assessment". Timepoint: before intervention, in the middle (6th session) and post intervention (12th session ). Method of measurement: "Wolf Motor Function Test" and "Fugl Meyer Assessment". " dependency in activity of daily living. Timepoint: before intervention, middle (six sessions post intervention) and post intervention (12th session). Method of measurement: The "Barthel Index". Grip Strength in force tester. Timepoint: before intervention, middle (six sessions post intervention) and post intervention (12th session). Method of measurement: "Force Tester". Vice Cancellor for Research of Iran University of Medical Sciences Approved 2020-02-29 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmmat Expressway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)