Sensorimotor Integration Exercises on Post-stroke Balance and Fall Efficacy

Stroke Clinical Trial

— SMIE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03584035
• Other study ID #: 3-2018
• Status: Completed
• Phase: N/A
• Start date: May 2, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: August 2019
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• sensory motor integration exercises
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
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.

Locations

Country	Name	City	State
Myanmar	National Rehabilitation Hospital	Yangon
Myanmar	Physical Medicine and Rehabilitation Department, Yangon General Hospital	Yangon

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	University of Medical Technology, Yangon

Country where clinical trial is conducted

Myanmar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Berg Balance Scale (BBS)	14 items to measure static and dynamic balance	6 weeks
Secondary	Functional Reach Test	To assess the stability by measuring the maximum distance while standing in a fixed position	6 weeks
Secondary	Fall Efficacy Scale	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.	6 weeks