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

Primary Purpose

Vestibular Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
vestibular Training Group
Virtual Reality Group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibular Rehabilitation focused on measuring Dizziness, balance, Subacute stroke

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pakistan General Railway Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vestibular Training Group

Virtual Reality Group

Arm Description

This Group will receive vestibular Adaptation and Balance exercises

This Group will receive virtual reality training by using exergaming.

Outcomes

Primary Outcome Measures

Timed up and Go test (TUG):
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.
Dynamic Gait Index:
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.

Secondary Outcome Measures

Dizziness Handicap Inventory
The Dizziness Handicap Inventory measures the self-perceived level of handicap associated with the symptom of dizziness. Its total score is 100

Full Information

First Posted
February 24, 2021
Last Updated
January 25, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04771169
Brief Title
Vestibular Rehabilitation Verses Virtual Reality on Dizziness, Balance and Gait in Subacute Stroke
Official Title
Comparison of Vestibular Rehabilitation With Virtual Reality on Dizziness, Balance and Gait in Subacute Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Rehabilitation
Keywords
Dizziness, balance, Subacute stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vestibular Training Group
Arm Type
Experimental
Arm Description
This Group will receive vestibular Adaptation and Balance exercises
Arm Title
Virtual Reality Group
Arm Type
Active Comparator
Arm Description
This Group will receive virtual reality training by using exergaming.
Intervention Type
Other
Intervention Name(s)
vestibular Training Group
Intervention Description
this Group will receive vestibular Adaptation & Balance exercises
Intervention Type
Other
Intervention Name(s)
Virtual Reality Group
Intervention Description
This Group will receive Virtual Reality Training by using exergaming.
Primary Outcome Measure Information:
Title
Timed up and Go test (TUG):
Description
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.
Time Frame
Change from Baseline mobility and balance to 8 Weeks
Title
Dynamic Gait Index:
Description
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.
Time Frame
Change from Baseline gait and balance to 8 Weeks
Secondary Outcome Measure Information:
Title
Dizziness Handicap Inventory
Description
The Dizziness Handicap Inventory measures the self-perceived level of handicap associated with the symptom of dizziness. Its total score is 100
Time Frame
Change from Baseline dizziness and balance to 8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Misbah Ghous, MSNMPT
Organizational Affiliation
Riphah International University Islamabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan General Railway Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29143805
Citation
Chavez LM, Huang SS, MacDonald I, Lin JG, Lee YC, Chen YH. Mechanisms of Acupuncture Therapy in Ischemic Stroke Rehabilitation: A Literature Review of Basic Studies. Int J Mol Sci. 2017 Oct 28;18(11):2270. doi: 10.3390/ijms18112270.
Results Reference
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PubMed Identifier
24259857
Citation
Chung EJ, Kim JH, Lee BH. The effects of core stabilization exercise on dynamic balance and gait function in stroke patients. J Phys Ther Sci. 2013 Jul;25(7):803-6. doi: 10.1589/jpts.25.803. Epub 2013 Aug 20.
Results Reference
background
PubMed Identifier
30828632
Citation
Osoba MY, Rao AK, Agrawal SK, Lalwani AK. Balance and gait in the elderly: A contemporary review. Laryngoscope Investig Otolaryngol. 2019 Feb 4;4(1):143-153. doi: 10.1002/lio2.252. eCollection 2019 Feb.
Results Reference
background
PubMed Identifier
25931744
Citation
Yom C, Cho HY, Lee B. Effects of virtual reality-based ankle exercise on the dynamic balance, muscle tone, and gait of stroke patients. J Phys Ther Sci. 2015 Mar;27(3):845-9. doi: 10.1589/jpts.27.845. Epub 2015 Mar 31.
Results Reference
background
PubMed Identifier
25435710
Citation
Kim WI, Choi YK, Lee JH, Park YH. The effect of muscle facilitation using kinesio taping on walking and balance of stroke patients. J Phys Ther Sci. 2014 Nov;26(11):1831-4. doi: 10.1589/jpts.26.1831. Epub 2014 Nov 13.
Results Reference
background
PubMed Identifier
27512255
Citation
Lee MM, Shin DC, Song CH. Canoe game-based virtual reality training to improve trunk postural stability, balance, and upper limb motor function in subacute stroke patients: a randomized controlled pilot study. J Phys Ther Sci. 2016 Jul;28(7):2019-24. doi: 10.1589/jpts.28.2019. Epub 2016 Jul 29.
Results Reference
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Vestibular Rehabilitation Verses Virtual Reality on Dizziness, Balance and Gait in Subacute Stroke

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