NCT04771169

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 9, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

February 24, 2021

Last Update Submit

January 25, 2022

Conditions

Keywords

DizzinessbalanceSubacute stroke

Outcome Measures

Primary Outcomes (2)

  • 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.

    Change from Baseline mobility and balance to 8 Weeks

  • 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.

    Change from Baseline gait and balance to 8 Weeks

Secondary Outcomes (1)

  • Dizziness Handicap Inventory

    Change from Baseline dizziness and balance to 8 Weeks

Study Arms (2)

Vestibular Training Group

EXPERIMENTAL

This Group will receive vestibular Adaptation and Balance exercises

Other: vestibular Training Group

Virtual Reality Group

ACTIVE COMPARATOR

This Group will receive virtual reality training by using exergaming.

Other: Virtual Reality Group

Interventions

this Group will receive vestibular Adaptation \& Balance exercises

Vestibular Training Group

This Group will receive Virtual Reality Training by using exergaming.

Virtual Reality Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients presented with neurological condition unrelated to stroke.
  • Patients that cannot provide informed consent for study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pakistan General Railway Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (6)

  • 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.

    PMID: 29143805BACKGROUND
  • 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.

    PMID: 24259857BACKGROUND
  • 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.

    PMID: 30828632BACKGROUND
  • 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.

    PMID: 25931744BACKGROUND
  • 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.

    PMID: 25435710BACKGROUND
  • 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.

    PMID: 27512255BACKGROUND

MeSH Terms

Conditions

Dizziness

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Misbah Ghous, MSNMPT

    Riphah International University Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2021

First Posted

February 25, 2021

Study Start

September 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 9, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations