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IRCT20221027056319N1 IRCT 2023-02-12 Arak University of Medical Sciences Effect of Otago exercise program on stroke Assessing the effect of the Otago exercise program on quality of life of stroke patients. 2023-03-10 anticipated 60 Complete https://irct.ir/trial/68305 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this research, the block randomization method will be used. The randomization unit was personal in this research, and afflicted patients to stroke had inclusion criteria to the research based on the file number, and people's intention to participate in this research was convenience non-random. Then, they were attributed to groups A and B by the block randomization method (quadruple block). In this research, 6 various modes can be imagined based on having a quadruple volume of blocks which include AABB, ABAB, ABBA BBAA, BABA, and BAAB. The various modes of blocks will be written on cardboard cards of the same size and color. According to the sample volume (60 patients) and 6 modes for blocks, ten cards were selected randomly with the re-substitution and indicated the order of blocks and order of patients in group A (control) and group B (intervention). N/A patients with stroke. Intervention 1: Description of intervention: the test group will receive the educational intervention including the Otago exercise program in person and 5-member groups by gender separation with the companion’s participation in 3 sessions. The educational program will be executed for all groups by the researcher and based on the published booklet by Otago University with the supervision of a physiotherapist. In addition, an illustrated book containing transparent instructions and an educational video about how to perform the exercises are given to the patients to fix the presented information and to have more accurate performance. The exercise level is determined based on the patient’s condition by the physiotherapist. Then, an exercise schedule will be given to the patients, and they will be asked to do and record the rigid exercises three times a week for 30- 40 min at home under the supervision. Moreover, the 15-minute walking program is given to the patient 2 times a week. The researcher will contact the patients at the end of each week to follow up on these exercises. Furthermore, the phone number of the researcher is given to the patients to call whenever they have a problem with their exercises, how to do them, or the level of exercises. Generally, this exercise program includes walking, turning the head to the sides, bending the body back, turning the body to the sides, moving the ankle up and down, straightening the knee (with weights), bending the knee, opening legs from the sides, standing on the toes, standing on the heels, bending the knees, walking on the toes, walking on the heels, putting the feet together, walking backward, standing on one leg, walking sideways, walking backward, getting up and sitting down from a chair, walking and turning, going up and down stairs, and stretching the muscles of the back of the leg and thigh. In addition to strength exercises, weights of 0.5-2 kg will be given to the patients based on their ability and the diagnosis of the physiotherapist. The patients were asked to make a video of their performed exercises each week to increase the assurance of doing the exercises accurately and sending it by EITA software. The exercise duration will be 8 weeks. The test groups will receive the usual care after the stroke in addition to the Otago exercise program. Intervention 2: Control group :The control group will receive the usual care after the stroke in all research period. In addition, the Otago exercise program will be given to the control group at the end of research for the ethical considerations. 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 There is no further information.
public Sajad Salehi
Corner of Hamidi nasab Alley., Tafresh st., Shohada Ave
Arak Iran (Islamic Republic of) 3814713497 +98 86 3425 1158 sajadsalehi878@gmail.com Arak University of Medical Sciences scientific Saiedeh Bahrampouri
Second floor, Faculty of Nursing, Arak University of Medical Sciences, Basij Square
Arak Iran (Islamic Republic of) 3819693345 +98 86 3425 1158 s.bahrampouri@arakmu.ac.ir Arak University of Medical Sciences Iran (Islamic Republic of) Diagnosis of stroke by a neurologist Passing less than 2 weeks after the patient’s stroke Being older than 60 years Getting a score 7 and higher in Abbreviated Mental Test (AMT) Getting the score of 3 and less in Modified Rankin Scale (MRS) in the stroke Having the companion Access to cell phone and EITAA application (by the patient or the companion) to contact and remember the exercises. 60 years no limit Both Having an experience of stroke in the past Having neurological disorders(dementia, Alzheimer's, Parkinson's, amyotrophic lateral sclerosis) Having musculoskeletal problems in the lower organs such as significant muscular weakness as severe joint osteoarthritis and pelvic bone fracture complications Having chronic renal failure Heart complication (congestive heart failure) and lung disorder. G46.4 Cerebellar stroke syndrome Rehabilitation Rehabilitation Description of intervention: the test group will receive the educational intervention including the Otago exercise program in person and 5-member groups by gender separation with the companion’s participation in 3 sessions. The educational program will be executed for all groups by the researcher and based on the published booklet by Otago University with the supervision of a physiotherapist. In addition, an illustrated book containing transparent instructions and an educational video about how to perform the exercises are given to the patients to fix the presented information and to have more accurate performance. The exercise level is determined based on the patient’s condition by the physiotherapist. Then, an exercise schedule will be given to the patients, and they will be asked to do and record the rigid exercises three times a week for 30- 40 min at home under the supervision. Moreover, the 15-minute walking program is given to the patient 2 times a week. The researcher will contact the patients at the end of each week to follow up on these exercises. Furthermore, the phone number of the researcher is given to the patients to call whenever they have a problem with their exercises, how to do them, or the level of exercises. Generally, this exercise program includes walking, turning the head to the sides, bending the body back, turning the body to the sides, moving the ankle up and down, straightening the knee (with weights), bending the knee, opening legs from the sides, standing on the toes, standing on the heels, bending the knees, walking on the toes, walking on the heels, putting the feet together, walking backward, standing on one leg, walking sideways, walking backward, getting up and sitting down from a chair, walking and turning, going up and down stairs, and stretching the muscles of the back of the leg and thigh. In addition to strength exercises, weights of 0.5-2 kg will be given to the patients based on their ability and the diagnosis of the physiotherapist. The patients were asked to make a video of their performed exercises each week to increase the assurance of doing the exercises accurately and sending it by EITA software. The exercise duration will be 8 weeks. The test groups will receive the usual care after the stroke in addition to the Otago exercise program. Control group :The control group will receive the usual care after the stroke in all research period. In addition, the Otago exercise program will be given to the control group at the end of research for the ethical considerations. Quality of life. Timepoint: Measuring the quality of life at the baseline (before the start of the intervention) and 1 and 3 months after the end of the intervention. Method of measurement: Stroke Impact Scale Questionnaire. Arak University of Medical Sciences Approved 2022-12-10 Ethics committee of Arak University of Medical Sciences Management of Research and Medical Information, Deputy of Research and Technology, University Complex of the Prophet (pbuh), Basij Square Arak Markazi Iran (Islamic Republic of)