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IRCT20220703055350N1 IRCT 2022-10-04 University of social welfare and rehabilitation sciences The effect of lateral balance training on falls in stroke The effect of frontal plane-focused balance training on balance performance and falls in chronic stroke 2022-10-17 anticipated 60 Complete https://irct.ir/trial/64596 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The 4-volume random block allocation method will be used. All possible 4 permutations will be listed in two groups (permutations 1 to 6 are as follows) A is the intervention group and B is the control group. 1-AABB 2-ABAB 3-BAAB 4-BABA 5-BBAA 6-ABBA Then, from a random number table with a random starting point, 6 numbers between 1 and 6 will be randomly selected (either using software or randomaize.com). For example, if the 6 random numbers obtained are 3 5 4 3 4 6 , It will mean that the first four people similar to block 3, the second four people similar to block 5 and ... will be allocated, Blinding description: This study will be performed in a double-blind manner and the blinding includes the participants, the person who analyzes the data and the experimenters who perform the pre- and post-treatment and 6-month follow-up evaluation are blind to the group allocation. Furthermore, physiotherapists who perform training are blind to pre-test, post-test and follow-up results. N/A stroke. Intervention 1: Intervention group: Frontal plane-focused balance training, including static and dynamic exercises focused on maintaining lateral balance. In the first 8 sessions single-task exercises will be accomplished. In the second 8 sessions motor dual task exercises will be done and in the third 8 sessions cognitive dual task exercises will be done. Intervention 2: Control group: Traditional balance training, including static and dynamic balance exercises focused on maintaining general and specially anterior- posterior balance. The same as intervention group, three 8-session therapeutic periods will be accomplished for the control group. Yes - There is a plan to make this available What will be shared: After hiding of personal information, demographic data will be shareable When: Data will be accessible 6 months after publishing. To whom: It will be available to all scholars and researchers working in an academia or a research center. Conditions: For academic researches, confirming the ethics code is needed to access data . Where to obtain: To receive data, send an e-mail to Dr. Iraj Abdollahi via irajabdollahi@hotmail.com or to Mitra Parsa via mitra.parsaa@gmail.com containing reasons for data access. How to obtain: It is imperative to explain the reasons for data access and features of research plan comprehensively. Comments:
public Dr. Iraj Abdollahi
kodakyar Ave., daneshjo Blvd.,Evin
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2218 0083 irajabdollahi@hotmail.com University of social welfare and rehabilitation sciences scientific Mitra Parsa
No.198, 2nd Khaghani, Khaghani Blv., Rezashahr
Mashhad Iran (Islamic Republic of) 9177753635 +98 51 3876 5444 mitra0parsaa@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) First ischemic or hemorrhagic stroke attack At least 6 months post stroke Only half of body was involved Be able to stand and walk for 1 minute and stand semi-tandem independently Have stable condition and not to suffer from any other diseases that affect balance Get 24 score or more in Mini-Mental State Examination (MMSE) Get standard deviation less than ±1 in Line Bisection test (not to suffer from hemineglect) have the score 2 or less in Modified Ashworth Scale in Gastrosoleos muscle 20 years 85 years Both Had a surgery on upper or lower extremity during last year Have contracture or deformity in lower limb Suffer from visual or auditory disorder Begin to take vitamin D at the same training time G46 Vascular syndromes of brain in cerebrovascular diseases Rehabilitation Rehabilitation Intervention group: Frontal plane-focused balance training, including static and dynamic exercises focused on maintaining lateral balance. In the first 8 sessions single-task exercises will be accomplished. In the second 8 sessions motor dual task exercises will be done and in the third 8 sessions cognitive dual task exercises will be done. Control group: Traditional balance training, including static and dynamic balance exercises focused on maintaining general and specially anterior- posterior balance. The same as intervention group, three 8-session therapeutic periods will be accomplished for the control group. Center of pressure parameters (postural control or balance). Timepoint: before training (pretest), after training (post test) and after 6 months follow-up. Method of measurement: force platform (Kistler). Fall history (rate of falling [Rate ratio] and risk of falling [Odds ratio]). Timepoint: from CVA incidence to beginning of training. Method of measurement: self-reporting. Berg balance scale score. Timepoint: pre-test, post-test and after 6 months follow-up. Method of measurement: Berg balance scale. Mini- Balance Evaluation Systems Test (Mini-BEST) score. Timepoint: pre-test, post-test and after 6 months follow-up. Method of measurement: Mini-Best. Activities-specific Balance Confidence (ABC) test score. Timepoint: pre-test, post-test and after 6 months follow-up. Method of measurement: ABC test. Falls risk for older people in the community (FROP-Com) screening tool score. Timepoint: pre-test, post-test and after 6 months follow-up. Method of measurement: FROP-Com screening tool test. Motor task performance score. Timepoint: pre-test, post-test and after 6 months follow-up. Method of measurement: reversed average of acceleration absolute value (three directions) measured by an accelerometer attached to the tray. Cognitive task performance score. Timepoint: pre-test, post-test and after 6 months follow-up. Method of measurement: rate of correct words to total words in Stroop test. University of social welfare and rehabilitation sciences Approved 2019-11-25 Ethics committee of university of social welfare and rehabilitation kodakyar Ave., daneshjo Blvd.,Evin Tehran Tehran Iran (Islamic Republic of)