Sensorimotor Integration Exercises on Post-stroke Balance and Fall Efficacy (SMIE)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Myanmar
Study Type
Interventional
Intervention
sensory motor integration exercises
conventional physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring sensory motor integration exercise
Eligibility 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
Sites / Locations
- National Rehabilitation Hospital
- Physical Medicine and Rehabilitation Department, Yangon General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sensory motor integration group
Conventional group
Arm Description
Sensory-motor integration exercises with 3 progressive steps, 30 minutes per sessions, 3 sessions per week for 6 weeks.
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.
Outcomes
Primary Outcome Measures
Berg Balance Scale (BBS)
14 items to measure static and dynamic balance
Secondary Outcome Measures
Functional Reach Test
To assess the stability by measuring the maximum distance while standing in a fixed position
Fall Efficacy Scale
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.
Full Information
NCT ID
NCT03584035
First Posted
June 29, 2018
Last Updated
August 12, 2019
Sponsor
Mahidol University
Collaborators
University of Medical Technology, Yangon
1. Study Identification
Unique Protocol Identification Number
NCT03584035
Brief Title
Sensorimotor Integration Exercises on Post-stroke Balance and Fall Efficacy
Acronym
SMIE
Official Title
Effects of Sensorimotor Integration Exercises on Balance and Fall Efficacy in Sub-acute Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
Collaborators
University of Medical Technology, Yangon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
sensory motor integration exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Trial
Masking
Outcomes Assessor
Masking Description
The outcome assessor will do all assessments (pre and post intervention) without group allocation.
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sensory motor integration group
Arm Type
Experimental
Arm Description
Sensory-motor integration exercises with 3 progressive steps, 30 minutes per sessions, 3 sessions per week for 6 weeks.
Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
sensory motor integration exercises
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
conventional physiotherapy
Intervention Description
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 Measure Information:
Title
Berg Balance Scale (BBS)
Description
14 items to measure static and dynamic balance
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Functional Reach Test
Description
To assess the stability by measuring the maximum distance while standing in a fixed position
Time Frame
6 weeks
Title
Fall Efficacy Scale
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
May Phyu Phyu Maung, B.Med.Tech
Organizational Affiliation
University of Medical Technology, Yangon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thin Thin Moe, Ph.D
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Myo Thuzar Khin, Ph.D
Organizational Affiliation
University of Medical Technology, Yangon
Official's Role
Study Chair
Facility Information:
Facility Name
National Rehabilitation Hospital
City
Yangon
ZIP/Postal Code
11062
Country
Myanmar
Facility Name
Physical Medicine and Rehabilitation Department, Yangon General Hospital
City
Yangon
Country
Myanmar
12. IPD Sharing Statement
Learn more about this trial
Sensorimotor Integration Exercises on Post-stroke Balance and Fall Efficacy
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