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NCT Number: NCT03584035

Sensorimotor Integration Exercises on Post-stroke Balance and Fall Efficacy

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Rehabilitation Hospital, Yangon, Burma

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sensory motor integration exercises

Behavioral

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.

Conventional Physiotherapy

Behavioral

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 outcomes

  1. Berg Balance Scale (BBS)

    Time frame: 6 weeks

    14 items to measure static and dynamic balance

Secondary outcomes

  1. Functional Reach Test

    Time frame: 6 weeks

    To assess the stability by measuring the maximum distance while standing in a fixed position

  2. Fall Efficacy Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • University of Medical Technology, Yangon

Registry information

Official study title

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

Acronym: SMIE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 12, 2018
Registry last updated
Aug 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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