Sensorimotor Integration Exercises on Post-stroke Balance and Fall Efficacy

NCT ID: NCT03584035

Last Updated: 2019-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-02
• Study Completion Date: 2019-07-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Sensory motor integration group

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

Group Type: EXPERIMENTAL

sensory motor integration exercises

Intervention Type: 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 group

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.

Group Type: ACTIVE_COMPARATOR

conventional physiotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Medical Technology, Yangon

OTHER

Sponsor Role: collaborator

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Thin Thin Moe

Ph D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

May Phyu Phyu Maung, B.Med.Tech

Role: PRINCIPAL_INVESTIGATOR

University of Medical Technology, Yangon

Thin Thin Moe, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Myo Thuzar Khin, Ph.D

Role: STUDY_CHAIR

University of Medical Technology, Yangon

Locations

National Rehabilitation Hospital

Yangon, , Burma

Physical Medicine and Rehabilitation Department, Yangon General Hospital

Yangon, , Burma

Countries

Burma

Other Identifiers

3-2018

Identifier Type: -

Identifier Source: org_study_id