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Clinical Trials/NCT04154969
NCT04154969UnknownNot Applicable

The Effect of Vestibulo-ocular Reflex Improving Exercise on Gait and Balance Among Post Stroke Sub Acute Patients

Prof. Dan Justo1 site in 1 country60 target enrollmentStarted: November 10, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Dynamic visual acuity test

Study Overview

Brief Summary

This study evaluate the effect of Vestibular rehabilitation program as part of physical therapy during rehabilitation post stroke. half of participants will receive vestibular exercise as part of the physiotherpy session, while the other half will receive a conservative physiotherapy session.

Detailed Description

Background Stroke global incidence is rising, in Israel 40% of the stroke patients are in need for hospitalized rehabilitation. Improving mobility, and in particular walking after stroke, is utterly important to reduce the risk of falling and is strongly correlated to higher patient autonomy and improved quality of life. During walking balance maintenance, is a complex function relying upon three modalities of sensory information. The sensory weighting process is compromised in stroke patients, so they are excessively reliant on visual information to control their posture. applying vestibular inputs, such as vestibulo-ocular reflex (VOR) habituation exercise, as part of vestibular focused rehabilitation (VR) is one of the methods to trigger sensory reweighting processes in post stroke patients. The VOR role in balance is to assist stabilizing images on the retina during head movement. It may be possible to explain the phenomena of head stabilization during gait in post stroke patients, as an attempt to maintain gaze stability due to reduced dynamic visual acuity (DVA) arising from decreased VOR function.

Aims The aims of this study are firstly to investigate the effectiveness of VOR exercise on gait speed and balance in post stroke patients with no dizziness, and secondly, to test the correlation between the efficiency of the VOR, as reflected by DVA and gait velocity.

Methods A prospective experimental study, randomized controlled, double blinded (assessor and statistician). Sixty adults, 65 years and older, hospitalized in the geriatric rehabilitation departments at the Sheba Medical Center, Israel will be divided to control and intervention groups. The intervention will include physiotherapy sessions including 10 minutes dedicated to VOR habituation exercise, comparing to physiotherapy sessions with no VOR exercise.

Prior to the baseline testing (T1), the participants will perform the outcome measures tests twice (two consecutive days) to determine the smallest real difference. Following this, the outcome measures will be tested at three time-points: before the beginning of the vestibular training (T1); three weeks later, at the termination of the vestibular training (T2) and three weeks after the termination of the training period (T3), to measure retention. For assessing gait and balance, the Dynamic Gait Index (appendix 1), the 10 Meters Walking Test (appendix 2) and the Timed Up and Go test (appendix 3) will be utilized. For assessing balance confidence the Activities-specific Balance Confidence Scale (ABC) questionnaire will be applied. For assessing the DVA, the Dynamic visual acuity test will be applied.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •within 0-3 months of a stroke (ischemic or hemorrhagic; anterior or posterior circulation; not vertebro-basilar stroke).

Exclusion Criteria

  • •any significant medical illness or blood pressure at rest>110/200 mmHg; a Mini-Mental State Exam score <24, global; a receptive aphasia or an inability to follow 2-point commands; unable to walk 16 meters with no physical assistance.

Arms & Interventions

intervention

Experimental

daily physiotherapy session as part of the rehab plan, which includes 10 minutes of vestibular exercize.

Intervention: Physiotherapy including Vestibular rehabilitation (Other)

control

Active Comparator

daily physiotherapy session as part of the rehab plan

Intervention: conventional Physiotherapy (Other)

Outcomes

Primary Outcomes

Dynamic visual acuity test

Time Frame: 5 minute

assessing the Vestibulo-ocular reflex by quantifying the visual acuity during head movement

10 Meters Walking Test

Time Frame: 1 minute

timing walking 10 meters walking

Dynamic Gait Index

Time Frame: 10 minute

scoring walking while performing deferent tasks, such as walking around obstacle, turn head while walking.

Timed Up and Go test

Time Frame: 1 minute

getting up from a chair, walk for 3 meters and back to the chair.

Activities-specific Balance Confidence Scale

Time Frame: 5 minute

questionnaire for balance confidence in deferent daily tasks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Prof. Dan Justo
Sponsor Class
Other Gov
Responsible Party
Sponsor Investigator
Principal Investigator

Prof. Dan Justo

Prof. Dan Justo

Sheba Medical Center

Study Sites (1)

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