Sensorimotor Integration Exercises on Post-stroke Balance and Fall Efficacy

NCT03584035 | Completed DMC

• 1 other identifier: 3-2018
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke

Keywords

sensory motor integration exercise

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale (BBS)

  14 items to measure static and dynamic balance

  6 weeks

Secondary Outcomes (2)

• Functional Reach Test

  6 weeks

• Fall Efficacy Scale

  6 weeks

Study Arms (2)

Sensory motor integration group

EXPERIMENTAL

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

Behavioral: sensory motor integration exercises

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.

Behavioral: conventional physiotherapy

Interventions

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.

Sensory motor integration group

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.

Conventional group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead
• University of Medical Technology, Yangon: collaborator

Study Sites (2)

National Rehabilitation Hospital

Yangon, 11062, Burma

Location

Physical Medicine and Rehabilitation Department, Yangon General Hospital

Yangon, Burma

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• May Phyu Phyu Maung, B.Med.Tech

  University of Medical Technology, Yangon

  PRINCIPAL INVESTIGATOR

• Thin Thin Moe, Ph.D

  Mahidol University

  PRINCIPAL INVESTIGATOR

• Myo Thuzar Khin, Ph.D

  University of Medical Technology, Yangon

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will do all assessments (pre and post intervention) without group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph D

Model Details: Randomized Control Trial

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 12, 2018
• Study Start: May 2, 2018
• Primary Completion: May 30, 2019
• Study Completion: July 30, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

BU (2)