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

Effects of Sensorimotor Integration Exercises on Balance and Fall Efficacy in Sub-acute Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: sensory motor integration exercises; Behavioral: conventional physiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Myanmar
  • Yangon, Myanmar
    • Physical Medicine and Rehabilitation Department, Yangon General Hospital
  • Yangon, Myanmar, 11062
    • National Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale (BBS)	14 items to measure static and dynamic balance	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Reach Test	To assess the stability by measuring the maximum distance while standing in a fixed position	6 weeks
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.	6 weeks

Collaborators and Investigators

• Sponsor: Mahidol University
• Collaborators: University of Medical Technology, Yangon
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2018
• Primary Completion (Actual): May 30, 2019
• Study Completion (Actual): July 30, 2019

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: June 29, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: sensory motor integration exercise
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 3-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No