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Sensorimotor Integration Exercises on Post-stroke Balance and Fall Efficacy (SMIE)

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ClinicalTrials.gov Identifier: NCT03584035
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
University of Medical Technology, Yangon
Information provided by (Responsible Party):
Thin Thin Moe, Mahidol University

Brief Summary:
To study the effect of sensorimotor integration exercises on balance and fall efficacy in sub-acute stroke by performing 18 balance training exercises with three progressive steps.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: sensory motor integration exercises Behavioral: conventional physiotherapy Not Applicable

Detailed Description:
Balance impairment after stroke is significantly correlated with fall risk. To improve balance and reduce fall efficacy, the participants in the study group will be trained by six weeks three progressive steps of sensorimotor integration exercises. Each exercise step will take 30 minutes of a practice session, three sessions per week. Conventional physiotherapy (passive and active exercises and lower extremities strengthening exercises) will be given to the control group. The changes in balance performance and fall efficacy will be measured and compared within and between groups.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Berg Balance Scale (BBS) [ Time Frame: 6 weeks ]
    14 items to measure static and dynamic balance


Secondary Outcome Measures :
  1. Functional Reach Test [ Time Frame: 6 weeks ]
    To assess the stability by measuring the maximum distance while standing in a fixed position

  2. 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.



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First episode of sub-acute stroke (from 1 to 26 weeks) referred from physicians
  • Both sexes
  • Age above 20
  • Good cognition (Mini Mental State Examination Scale ≥24)
  • Moderate and moderately severe disability (Modified Rankin Scale- 3 and 4)
  • Impaired balance (BBS <41)

Exclusion Criteria:

  • Recurrent stroke
  • Associated with other neurological conditions (such as Parkinson's disease, Epilepsy, meningitis)
  • Deficits of somatic sensation involving the paretic limb (Fugl-Meyer Assessment - sesation< 1)
  • Lower extremity weight bearing pain (Fugl-Meyer Assessment- pain <1)
  • Low back pain (VAS ≥ 3)
  • Severe visual deficits which cannot be corrected by lens or glasses
  • Symptomatic vestibular disorders (Paroxysmal postural vertigo)
  • Associated serious cardiac disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584035


Locations
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Myanmar
National Rehabilitation Hospital
Yangon, Myanmar, 11062
Physical Medicine and Rehabilitation Department, Yangon General Hospital
Yangon, Myanmar
Sponsors and Collaborators
Mahidol University
University of Medical Technology, Yangon
Investigators
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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

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Responsible Party: Thin Thin Moe, Ph D, Mahidol University
ClinicalTrials.gov Identifier: NCT03584035     History of Changes
Other Study ID Numbers: 3-2018
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thin Thin Moe, Mahidol University:
sensory motor integration exercise

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases