Persistent Postural Perceptual DizzinessVRNCT06479408
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).
A study testing progressive muscle relaxation (PMR) technique and vestibular rehabilitation exercises and virtual reality (VR) in people with Persistent Postural Perceptual Dizziness, run by Shalamar Institute of Health Sciences at 1 site in Pakistan.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Persistent Postural Perceptual Dizziness
- What is being tested?
- progressive muscle relaxation (PMR) technique and vestibular rehabilitation exercises and virtual reality (VR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Jun 2024to 28 Dec 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shalamar School of Allied Health Sciences
Lahore, Punjab Province, 54000
dr masooma gull, 03244283378, masoomagull2@ymail.com
MADIHA IQBAL, 03304003445, madihabiostats@gmail.com
About this study
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.
- Conditions
- Persistent Postural Perceptual Dizziness
- Being tested
- progressive muscle relaxation (PMR) technique and vestibular rehabilitation exercises, virtual reality (VR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
progressive muscle relaxation (PMR) technique and vestibular rehabilitation exercisesOther
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.
virtual reality (VR)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: virtual reality (VR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start28 Jun 2024 (estimated)
- Primary completion28 Oct 2024 (estimated)
- Study completion28 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Postural Perceptual DizzinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalamar Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hmna afzal, Shalamar Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479408
- Sponsor's protocol ID
- ShalamarIHS-701
- Acronym
- VR
- Status last verified
- Jun 2024
- First submitted
- 24 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.