Sensorimotor Integration Exercises on Post-stroke Balance and Fall Efficacy (SMIE)
|ClinicalTrials.gov Identifier: NCT03584035|
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Behavioral: sensory motor integration exercises Behavioral: conventional physiotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Control Trial|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The outcome assessor will do all assessments (pre and post intervention) without group allocation.|
|Official Title:||Effects of Sensorimotor Integration Exercises on Balance and Fall Efficacy in Sub-acute Stroke|
|Actual Study Start Date :||May 2, 2018|
|Actual Primary Completion Date :||May 30, 2019|
|Actual Study Completion Date :||July 30, 2019|
Experimental: Sensory motor integration group
Sensory-motor integration exercises with 3 progressive steps, 30 minutes per sessions, 3 sessions per week for 6 weeks.
Behavioral: sensory motor integration exercises
Sensorimotor integration exercises will be given in study group. The exercises will be performed in standing, sitting and walking. Exercises will be progressively increased from eye open to closed , floor to mat and head turns to right & left under the supervision of physiotherapist. Sensorimotor integration exercises will take 45 minutes in each session.
Active Comparator: Conventional group
Conventional exercises include simple passive and active exercises and lower extremities strengthening exercises for balance and ambulation. The exercise session will last 30 minutes for 3 sessions per week. The total intervention period is 6 weeks.
Behavioral: conventional physiotherapy
Conventional physiotherapy will take 30 minutes in each session, taking three sessions per weeks for six weeks. The exercises include simple lower extremity exercise and ambulatory training such as sit to stand, stepping, lateral and backward walking, and tandom walking etc.
- Berg Balance Scale (BBS) [ Time Frame: 6 weeks ]14 items to measure static and dynamic balance
- Functional Reach Test [ Time Frame: 6 weeks ]To assess the stability by measuring the maximum distance while standing in a fixed position
- Fall Efficacy Scale [ Time Frame: 6 weeks ]Short, easy questionnaire that provides information about how much fear of fall, which is comprised of 16-items concerning confidence in maintaing balance during activities.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584035
|National Rehabilitation Hospital|
|Yangon, Myanmar, 11062|
|Physical Medicine and Rehabilitation Department, Yangon General Hospital|
|Principal Investigator:||May Phyu Phyu Maung, B.Med.Tech||University of Medical Technology, Yangon|
|Principal Investigator:||Thin Thin Moe, Ph.D||Mahidol University|
|Study Chair:||Myo Thuzar Khin, Ph.D||University of Medical Technology, Yangon|