NCT06479408

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

June 24, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 28, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

June 28, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2024

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

June 24, 2024

Last Update Submit

June 28, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • balance

    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 Outcomes (1)

  • stress

    2 months

Study Arms (2)

progressive muscle relaxation (PMR) and vestibular rehabilitation exercises

OTHER

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

virtual reality (VR)

OTHER

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)

Interventions

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.

progressive muscle relaxation (PMR) and vestibular rehabilitation exercises

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.

virtual reality (VR)

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalamar School of Allied Health Sciences

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • 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.

    BACKGROUND

MeSH Terms

Interventions

Autogenic TrainingMethods

Intervention Hierarchy (Ancestors)

HypnosisMind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and ActivitiesInvestigative Techniques

Central Study Contacts

hmna afzal, DPT

CONTACT

sadaf ghafoor, DPT

CONTACT

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
PRINCIPAL INVESTIGATOR
PI Title
student of final year DPT ( doctor of physical therapy)

Study Record Dates

First Submitted

June 24, 2024

First Posted

June 28, 2024

Study Start

June 28, 2024

Primary Completion

October 28, 2024

Study Completion

December 28, 2024

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations