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Not yet recruitingNCT06479408VRUpdated Jul 1, 2024

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).

An interventional study of progressive muscle relaxation (PMR) technique and vestibular rehabilitation exercises and virtual reality (VR) in Persistent Postural Perceptual Dizziness, sponsored by Shalamar Institute of Health Sciences. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2024-07-01.

Sponsored by Shalamar Institute of Health Sciences · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
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Study 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).

Read the 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.

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Conditions studied

  • Persistent Postural Perceptual Dizziness

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In context

Dizziness

226 studies on the registry are indexed under Dizziness; 56 are open to participants now.

This study's planned enrollment of 25 is below the median of 43 across 170 interventional studies indexed under Dizziness.

Browse Dizziness studies →

Lead sponsor

Shalamar Institute of Health Sciences is the lead sponsor of 17 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
25 participants (estimated)

Study arms

  • 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

  • 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)

Interventions

  • Otherprogressive 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.

  • Othervirtual 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.

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What researchers measure

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.

    Time frame: 2 months

Secondary outcomes

  1. stress

    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)

    Time frame: 2 months

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Study locations

1 site
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References and documents

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.

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2024; primary completion for Oct 2024, 4 months later.

Of 82 non-industry interventional studies with no phase under Dizziness, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's planned 4 months is below that.

Counting every sponsor, half of 90 studies reached it within 20 months; a quarter within 8 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 24, 2024
First posted
Jun 28, 2024
StartEst.
Jun 28, 2024
Primary completionEst.
Oct 28, 2024
CompletionEst.
Dec 28, 2024
Last update
Jul 1, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06479408
Lead sponsor
Shalamar Institute of Health Sciences
Responsible party
hmna afzal (student of final year DPT ( doctor of physical therapy), Shalamar Institute of Health Sciences) — Principal investigator
First posted
Jun 28, 2024
Start date
Jun 28, 2024 (estimated)
Primary completion
Oct 28, 2024 (estimated)
Completion
Dec 28, 2024 (estimated)
Last update
Jul 1, 2024

Study contacts

hmna afzal, DPT
Contact
hmnabaig1050@gmail.com
03014781108
sadaf ghafoor, DPT
Contact
sadafghafoor89@gmail.com
03260793783

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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