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Clinical Trials/NCT03584035
NCT03584035CompletedNot Applicable

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

Mahidol University2 sites in 1 country46 target enrollmentStarted: May 2, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
46
Locations
2
Primary Endpoint
Berg Balance Scale (BBS)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

The outcome assessor will do all assessments (pre and post intervention) without group allocation.

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Sensory motor integration group

Experimental

Sensory-motor integration exercises with 3 progressive steps, 30 minutes per sessions, 3 sessions per week for 6 weeks.

Intervention: sensory motor integration exercises (Behavioral)

Conventional group

Active Comparator

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: conventional physiotherapy (Behavioral)

Outcomes

Primary Outcomes

Berg Balance Scale (BBS)

Time Frame: 6 weeks

14 items to measure static and dynamic balance

Secondary Outcomes

  • Fall Efficacy Scale(6 weeks)
  • Functional Reach Test(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Thin Thin Moe

Ph D

Mahidol University

Study Sites (2)

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