Vestibular Rehabilitation Verses Virtual Reality on Dizziness, Balance and Gait in Subacute Stroke

January 25, 2022 updated by: Riphah International University

Comparison of Vestibular Rehabilitation With Virtual Reality on Dizziness, Balance and Gait in Subacute Stroke Patients

There is paucity of literature in studying the comparative effects of Vestibular Rehabilitation and Virtual Reality. This study will determine the effects of these interventions on dizziness, balance and gait. This study will also deduce the role of vestibular rehabilitation and Virtual reality in subacute stroke patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stroke is defined as rapidly developing clinical signs of focal disturbance of cerebral function that lasts more than 24 hours or leading to death. It arises from vascular causes such as cerebral infarction, intracerebral hemorrhage or subarachnoid hemorrhage. Stroke refers to any damage to the brain due to abnormality of blood supply. Stroke patients have difficulty in maintaining balance and postural control because they have asymmetric posture, abnormal body imbalance and difficulty in weight transfer.

Balance is required to maintain posture, to respond to voluntary movements and react to external perturbations. Because of the balance disorders, compensatory movements occur in stroke patients which causes them to consume more energy compared to healthy subjects and causes the development of inefficient walking pattern.

Gait function determines the degree of physical ability of post-stroke patients and their ability to perform independent mobility during activities of daily living (ADL). Stroke patients acquire compensatory abnormal walking pattern as a result of muscular weakness and inability to maintain balance.

Virtual reality rehabilitation systems provide direct sensorial feedback to which a person can respond and interact with environment. VR environments are commonly used in treating, training, and rehabilitation of stroke patients. In virtual reality rehabilitation, the patient moves and performs predetermined tasks as if he is performing the actions in reality.

According to a study conducted by Hyung Young Lee, Virtual reality-based training has been used as therapeutic intervention for functional recovery of stroke patients. It provides a variety of environments based on the requirements of patients that can be selected for recovery.

According to a study conducted by Yurong Mao, Virtual reality balance training provides more realistic proprioceptive and visual input and improves balance and gait function effectively. Virtual reality balance games can be used as an effective tool to train patients with balance dysfunction.

Literature describes Virtual Reality training is effective in improving dynamic balance control and preventing falls in subacute stroke patients. Virtual reality training provides stroke patients with planned and consistent exercises to improve balance and gait by giving visual feedback to directly adjust their wrong weight center and shift visually.

Its reported that Vestibular rehabilitation is frequently used treatment for dizziness and balance problems. Vestibular Rehabilitation is a combination of different exercise components with an aim to improve gaze stability, balance and gait and facilitate somatosensory integration. It is used in treatment of stroke patients to improve dynamic balance by acting on the vestibular system, thus facilitating recovery.

A study indicated that, the main components of vestibular rehabilitation are gaze stabilization exercises to help adapt the VOR function and balance exercises to retrain the vestibulospinal reflex function. Thus, simultaneously measuring changes in the VOR function and gait performance before and after intervention will provide valuable information for rehabilitation.

Vestibular system plays a phase dependent role in gait and is active at certain points in the gait cycle including double support, changing direction, and step termination.

VRT is patient dependent and progression of the exercises depends upon individual patient's sensorimotor, cognitive, and emotional aspects.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Pakistan General Railway Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • • Subacute stroke patients. 1 to 6 months

    • Both male and female subacute stroke patients with age 40-70 years.
    • Patients with positive Head Thrust Test.
    • Patients with Vestibular Disorders.
    • Modified Rankin scale score 1-4
    • Score >25 on MMSE

Exclusion Criteria:

  • • Patients presented with neurological condition unrelated to stroke.

    • Patients that cannot provide informed consent for study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vestibular Training Group
This Group will receive vestibular Adaptation and Balance exercises
Other: vestibular Training Group
this Group will receive vestibular Adaptation & Balance exercises
Active Comparator: Virtual Reality Group
This Group will receive virtual reality training by using exergaming.
Other: Virtual Reality Group
This Group will receive Virtual Reality Training by using exergaming.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed up and Go test (TUG):
Time Frame: Change from Baseline mobility and balance to 8 Weeks
Timed Up and Go test (TUG) is used to assess balance and mobility in patients with stroke. An older adult who takes ≥12 seconds to complete the TUG is at risk for falling.
Change from Baseline mobility and balance to 8 Weeks
Dynamic Gait Index:
Time Frame: Change from Baseline gait and balance to 8 Weeks
DGI quantifies the dynamic balance instability and is a performance based tool. It evaluates the ability of the individual to modify gait in response to changing functions during walking. Its total score is 24.
Change from Baseline gait and balance to 8 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dizziness Handicap Inventory
Time Frame: Change from Baseline dizziness and balance to 8 Weeks
The Dizziness Handicap Inventory measures the self-perceived level of handicap associated with the symptom of dizziness. Its total score is 100
Change from Baseline dizziness and balance to 8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Misbah Ghous, MSNMPT, Riphah International university Islamabad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

February 24, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

February 9, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/00830 Vishal Sana

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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