The Effect of Virtual Reality (VR) Versus Conventional Vestibular Rehabilitation and Progressive Muscle Relaxation (PMR) to Improve Balance and Stress Among Patients of Persistent Postural Perceptual Dizziness (PPPD). (VR)

June 28, 2024 updated by: hmna afzal, Shalamar Institute of Health Sciences
To compare the effect of virtual reality (VR) versus conventional vestibular rehabilitation and progressive muscle relaxation (PMR) to improve balance and stress among patients of persistent postural perceptual dizziness (PPPD).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Through this randomized controlled trial, we evaluate the effectiveness of three modern interventions in patients with persistent postural perceptual dizziness. In order to study the novel facets of PPPD and to cover a large research gap, it is necessary to explore the psychological and physiological aspects of PPPD. At individualized levels, this study aimed to enable patients to become more independent in their social and personal lives by overcoming stress and balance issues. Socially, it reduces stigma by raising awareness, promoting understanding, providing better health access, facilitating communities, and promoting a more supportive and inclusive environment. This research can refine rehabilitation therapies at the institutional level and enhance health care provider training. It increases treatment and resource allocation, leading to better outcomes in the field. It provides a new platform for research.

Study Type

Interventional

Enrollment (Estimated)

25

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 Contact

Study Contact Backup

Study Locations

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age groups ranging 18-25 years and having symptoms of dizziness, and lightheadedness over the period of >3months while having predisposing stress factor. The Individuals who are ready to take part willingly in the follow up sessions should be included in the research

Exclusion Criteria:

  • The participants who have any other neurological disease and cause of dizziness are excluded from this study. There should be no history of smoking, drug abuse and alcohol, and any other neurological condition that affects the balance. Subjects with active Meniere's disease /BPPV/bilateral vestibulopathy are also excluded.

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
Other: progressive muscle relaxation (PMR) and vestibular rehabilitation exercises
GROUP A will be treated by progressive muscle relaxation (PMR) technique as a mean of stress relaxation and vestibular rehabilitation exercises for postural stability through Swiss ball, BOSU ball, balance board etc.
Other: progressive muscle relaxation (PMR) technique and vestibular rehabilitation exercises
A will be treated by progressive muscle relaxation (PMR) technique as a mean of stress relaxation and vestibular rehabilitation exercises for postural stability through Swiss ball, BOSU ball, balance board etc. Other components of vestibular rehab including gaze stability enhancement, improvement in vertigo and activities of daily living will also be focused.
Other: virtual reality (VR)
GROUP B will follow virtual reality (VR) based intervention program where three dimensional-3D environments will be used reduce stress and improve balance.
Other: virtual reality (VR)
virtual reality (VR) based intervention program where three dimensional-3D environments will be used reduce stress and improve balance. A Simulator Sickness Questionnaire (SSQ) will be filled by participants before and after each session of VR to discriminate whether VR is provoking the symptoms or not.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
balance
Time Frame: 2 months
Both groups will be given 3 treatment sessions per week . A thorough evaluation will be done again at the end of intervention period to find the difference between pre and post- interventional scores.Balance will be measured by using miniBESTest ( balance evaluation system test) with a cut of range 0-28 points there will be 14 items each item is categorised in three levels in whole while 0 representing low level of function and 2 representing the highest level of function.
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stress
Time Frame: 2 months
Both groups will be given 3 treatment sessions per week. A thorough evaluation will be done again at the end of intervention period to find the difference between pre and post- interventional scores.stress will be calculated by using perceived stress scale which will incude 10 questions each question is categorised into 5 likert scales with scoring ranging as 0-13 (low stress), 14-26 (moderate stress), 27-40 (high stress)
2 months

Collaborators and Investigators

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

Sponsor

Shalamar Institute of Health Sciences

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

  • Laryngology. 2023;132(5):566-77. 6. Ibrahim NMK, Hazza NMA, Yaseen DM, Galal EM. Effect of vestibular rehabilitation games in patients with persistent postural perceptual dizziness and its relation to anxiety and depression: prospective study. European Archives of Oto-Rhino- Laryngology. 2023:1-9. 7. Yamaguchi T, Miwa T, Tamura K, Inoue F, Umezawa N, Maetani T, et al. Temporal virtual reality-guided, dual-task, trunk balance training in a sitting position improves persistent postural-perceptual dizziness: proof of concept. Journal of neuroengineering and rehabilitation. 2022;19(1):92. 8. Webster KE, Kamo T, Smith L, Harrington-Benton NA, Judd O, Kaski D, et al. Non-pharmacological interventions for persistent postural-perceptual dizziness (PPPD). Cochrane Database of Systematic Reviews. 2023(3). 9. Knight B, Bermudez F, Shermetaro C. Persistent postural-perceptual dizziness. 2022. 10. Mandal S. Brief introduction of virtual reality & its challenges. International Journal of Scientific & Engineering Research. 2013;4(4):304-9. 11. Writer H, Arora R. Vestibular rehabilitation: An overview. Int J Otorhinolaryngol Clin. 2012;4(1):54-69. 12. Jacob S, Sharma S. Efficacy of progressive muscular relaxation on coping strategies and management of stress, anxiety and depression. Int J Indian Psychol. 2018;6(1):106-24. 13. Michie S. Causes and management of stress at work. Occupational and environmental medicine. 2002;59(1):67-72. 14. Herdman D, Norton S, Murdin L, Frost K, Pavlou M, Moss-Morris R. The INVEST trial: a randomised feasibility trial of psychologically informed vestibular rehabilitation versus current gold standard physiotherapy for people with Persistent Postural Perceptual Dizziness. Journal of neurology. 2022;269(9):4753-63.

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 (Estimated)

June 28, 2024

Primary Completion (Estimated)

October 28, 2024

Study Completion (Estimated)

December 28, 2024

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 28, 2024

Study Record Updates

Last Update Posted (Actual)

July 1, 2024

Last Update Submitted That Met QC Criteria

June 28, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShalamarIHS-701

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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