Sensorimotor Integration Exercises on Post-stroke Balance and Fall Efficacy

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Behavioral: conventional physiotherapy; Behavioral: sensory motor integration exercises

• Registration Number: NCT03584035
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-05-02
• Study First Submitted: 2018-06-29
• Study First Submitted QC: 2018-06-29
• Study First Posted: 2018-07-12
• Primary Completion: 2019-05-30
• Study Completion: 2019-07-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional group	conventional physiotherapy	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.
Sensory motor integration group	sensory motor integration exercises	Sensory-motor integration exercises with 3 progressive steps, 30 minutes per sessions, 3 sessions per week for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Berg Balance Scale (BBS)	6 weeks	14 items to measure static and dynamic balance

Secondary Outcome Measures

Name	Time	Method
Fall Efficacy Scale	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.
Functional Reach Test	6 weeks	To assess the stability by measuring the maximum distance while standing in a fixed position

Trial Locations

Locations (2)

National Rehabilitation Hospital; 🇲🇲 Yangon, Myanmar

Physical Medicine and Rehabilitation Department, Yangon General Hospital; 🇲🇲 Yangon, Myanmar