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Clinical Trials/NCT03584035
NCT03584035
Completed
N/A

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

Mahidol University2 sites in 1 country46 target enrollmentMay 2, 2018
ConditionsStroke

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Mahidol University
Enrollment
46
Locations
2
Primary Endpoint
Berg Balance Scale (BBS)
Status
Completed
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
May 2, 2018
End Date
July 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Thin Thin Moe

Ph D

Mahidol University

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

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)

Study Sites (2)

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