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IRCT20240714062437N1 IRCT 2024-11-15 The University of Lahore Effects of Multi-modal Balance Training with and without Auditory cues on balance, Gait Mobility, Risk of Fall and Quality of Life in Patients with Chronic Sroke Effects of Multi-modal Balance Training with and without Auditory cues on balance, Gait Mobility, Risk of Fall and Quality of Life in Patients with Chronic Sroke 2024-05-29 anticipated 42 Complete https://irct.ir/trial/79892 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: all the screened and willing participants will be randomly allocated into tw groups ( Group A and Group B) by computerized generated method, Blinding description: study will be single and assessor blinded. Participants will be masked about other groups but they will know what treatment they will be receiving or what exercises they will be doing. Principal investigator would also not be masked or blinded because investigator would be applying the techniques or participants of both groups. 3 Stroke. in this study, patients are allocated into two groups. Both experimental groups received balance training; one intervention group received multi modal balance training exercises combined with auditory cues provided by a metronome (RAS-supported multimodal balance intervention), whereas the other intervention group received balance training exercises without auditory cues (only multimodal balance training). Multimodal balance training exercises in the intervention are: Ball lifted over head in sitting position, Trunk stability in seatedposition, Stability upright posture when holding a stick, Trunk twist with ball in sittingposition, Weight shifts, Balance on both feet with visual cues, Latero-lateral stepsingle-leg balance, walking with visual cues and foam, make side-steps, walking withvisual cues and cones, Diagonal reaching with ball, sit to Stand, Twisting. Participants of each group will perform 24 sessions (over 12 weeks) on alternative days in a week. The duration ofeach session will be 45 minutes lasting 10 minutes each with rest breaks. Effects of interventions will be measured after 6th week and after 12th week.. Yes - There is a plan to make this available What will be shared: Demographic data and data related to final outcome will be shared by maintaining the confidenfidentially When: Data will be available after the publication of findings till twelve months To whom: Hammad Sattar Conditions: For research purpose Where to obtain: To the corresponding of the study, Hammad Sattar, and can contact on 00923447089190, hammadsattarpt@gmail.com How to obtain: Open access and there is traditional public data release where anyone can get access to the data Comments:
public Hammad Sattar
1-km Defence Road, near Bhuptian Chowk, Lahore, Punjab
Lahore Pakistan 54590 +92 344 7089190 hammadsattarpt@gmail.com The University of Lahore scientific Hammad Sattar
1-km Defence Road, near Bhuptian Chowk, Lahore, Punjab
Sialkot Pakistan 54590 +92 344 7089190 hammadsattarpt@gmail.com The University of Lahore Pakistan both genders are included individuals with the age of between 45-70 years individuals with absent or less than grade 2 spasticity in modified ashworth scale in affected extremity indviduals having only one sided stroke individuals having score of less than 52 out of 56 in berg balnce scale 45 years 70 years Both individuals who have any kind of cardiac disorder i.e. myocardial infarction etc individuals who have any orthopedic disorder i.e. arthritis etc indivduals who have any respiratory condition such as asthma etc. individuals who have non-healing ulcers individuals who have some visuospastial problems i.e. hemi-neglect etc G46 Vascular syndromes of brain in cerebrovascular diseases Rehabilitation in this study, patients are allocated into two groups. Both experimental groups received balance training; one intervention group received multi modal balance training exercises combined with auditory cues provided by a metronome (RAS-supported multimodal balance intervention), whereas the other intervention group received balance training exercises without auditory cues (only multimodal balance training). Multimodal balance training exercises in the intervention are: Ball lifted over head in sitting position, Trunk stability in seatedposition, Stability upright posture when holding a stick, Trunk twist with ball in sittingposition, Weight shifts, Balance on both feet with visual cues, Latero-lateral stepsingle-leg balance, walking with visual cues and foam, make side-steps, walking withvisual cues and cones, Diagonal reaching with ball, sit to Stand, Twisting. Participants of each group will perform 24 sessions (over 12 weeks) on alternative days in a week. The duration ofeach session will be 45 minutes lasting 10 minutes each with rest breaks. Effects of interventions will be measured after 6th week and after 12th week. Balance. Timepoint: 12 weeks. Method of measurement: The Berg Balance Scale (BBS) is one of the most widely used tools for balance assessment. The BBS is a 14-item scale that quantitatively assesses balance and risk for falls in older community-dwelling adults through direct observation of their performance. The scale requires 10 to 20 minutes to complete and measures the patient’s ability to maintain balance—either statically or while performing various functional movements for a specified duration of time. The items are scored from 0 to 4, with a score of 0 representing an inability to complete the task and a score of 4 representing independent item completion. A global score is calculated out of 56 possible points. Scores of 0 to 20 represent balance impairment, 21 to 40 represent acceptable balance, and 41 to 56 represent good balance. The BBS measures both static and dynamic aspects of balance. Gait mobility. Timepoint: 12 weeks. Method of measurement: The TUG test is a composite measure of functional mobility. The TUG was originallycreated to predict fall risk in geriatric patients. It includes executive function (listening andinitiating movements), transfer tasks (standing up and sitting down), walking, and balance.The TUG is performed by having the patient seated in a chair and with the command “go”,rise from the chair, walk 3 meters, turn around, return to chair and sit. The trial is timedfrom when the patient’s back leaves the backrest to when the patient returns to the seatedposition, and the patient is allowed one practice trial. TUG score of 13.5 seconds or morecould rule in the risk of a fall. Risk of fall. Timepoint: 12 weeks. Method of measurement: The Falls Efficacy Scale International (FES-I) is a measure of “fear of falling” or “concerns about falling”. The FES-I is intended to be used in adult population to measure the level of concern about falling during social and physical activities inside and outside the home whether or not the person actually does the activity. It is a 16 item questionnaire, useful to the researchers and clinicians interested in fear of falling, with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling). In this scale individuals are instructed to score their concern of falling during an activity on a 4 point Likert scale with 1 as not concerned at all and 4 as very concerned. The item scores are summed up to obtain a total, with higher the score, higher being the concern for falling. Quality of life. Timepoint: 12 weeks. Method of measurement: The Stroke Specific Quality of Life scale (SS-QOL) is a patient-centered outcome measureintended to provide an assessment of health-related quality of life (HRQOL) specific topatients with stroke. Patients must respond to each question of the SS-QOL with referenceto the past week. It is a self-report scale containing 49 items in 12 domains. The score is between 49-245, having high score with better quality of life. None Approved 2024-05-22 Research Ethics Committee of University of Lahore University of Lahore Teaching Hospital Lahore, Punjab, Pakistan Lahore Punjab Pakistan