Benign Paroxysmal Positional VertigoNCT06738823
Effect of Wii Fit Training in Comparison to Vestibular Rehabilitation Training on Balance in Patients With Benign Paroxysmal Postional Vertigo
A study testing INTERVENTION GROUP : TRAINING WITH WIIFIT and VESTIBULAR REHABILITATION TRAINING in people with Benign Paroxysmal Positional Vertigo and Balance, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
THIS STUDY IS A RANDOMIZED CONTROL TRIAL AND THE PURPOSE OF THE STUDY IS TO DETERMINE THE EFFECT OF WIIFIT TRAINING IN COMPARISON TO VESTIBULAR REHAB TRAINING ON BALANCE IN PATIENTS WITH BENIGN PAROXYSMAL POSITIONAL VERTIGO Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo, Balance, Vertigo
- What is being tested?
- INTERVENTION GROUP : TRAINING WITH WIIFIT and VESTIBULAR REHABILITATION TRAINING
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jul 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with benign paroxysmal positional vertigo.
- Aged 30-60 years.
- Ability to stand and walk independently.
- Male and Female
- Positive Dix Hallpike Test
- DHI Scale: 36-42 (moderate Handicap)
Who cannot join
- patients with history of vestibular surgery or cochlear implantation.
- Patients with history of seizures or epilepsy.
- patients with a pacemaker or implantable cardioverter-defibrillator(ICD).
- Patients with history of severe head injury or concussion within the past year.
- No other vestibular disorders or conditions that may affect balance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Islamabad, 44000
SANA KHALID, MS-NMPT, +92344-4218174, sana.khalid@fui.edu.pk
About this study
THIS STUDY IS A RANDOMIZED CONTROL TRIAL AND THE PURPOSE OF THE STUDY IS TO DETERMINE THE EFFECT OF WIIFIT TRAINING IN COMPARISON TO VESTIBULAR REHAB TRAINING ON BALANCE IN PATIENTS WITH BENIGN PAROXYSMAL POSITIONAL VERTIGO
Read the detailed description
Effects of wiifit training will be assessed for balance and vertigo which includes the parameters of balance training.
Benign Paroxysmal Positional Vertigo patients aged 30-60 years The participants will be assessed through Vestibular Rehabilitation questionnaire (VRBQ), Dizziness handicap inventory (DHI), Functional reach test, Clinical test for sensory integration in balance and vertigo symptom scale.
Informed consent will be taken after which the participants will be recruited into two groups, where one group will receive wiifit training and other group will receive vestibular rehabilitation training.
Base-line and post-treatment measurement will be taken for analysis.
- Conditions
- Benign Paroxysmal Positional Vertigo, Balance, Vertigo
- Being tested
- INTERVENTION GROUP : TRAINING WITH WIIFIT, VESTIBULAR REHABILITATION TRAINING
- Medical subject headings
- Benign Paroxysmal Positional Vertigo, Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTERVENTION GROUP : TRAINING WITH WIIFITProcedure or surgery
RCT (RANDOMIZED CONTROL TRIAL) GROUP 1 : Wii FIT TRAINING TIGHT ROPE TENSION, SKI SLALOM, PENGUIN SLIDE, TABLE TILT GROUP 2 : VESTIBULAR REHABILITATION TRAINING WEIGHT SHIFTING, NECK ROTATIONS, SIT TO STAND EXERCISES ON PADDED MAT AND HEAD MOVEMENTS WITH EYES CLOSED.
VESTIBULAR REHABILITATION TRAININGProcedure or surgery
WEIGHT SHIFTING, NECK ROTATIONS, SIT TO STAND EXERCISES ON PADDED MAT AND HEAD MOVEMENTS WITH EYES CLOSED.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group A | Experimental | The participants will receive intervention through Wii fit training which includes games tight rope tension, ski slalom, penguin slide, table tilt, and heading for 6 total 6 weeks.
3 days per week session will be given for 30 minutes including 5-minutes warmup and cool down and 5 minutes of break in between to avoid fatigue. Receives: Procedure: INTERVENTION GROUP : TRAINING WITH WIIFIT |
| Experimental group B | Active comparator | The participants will receive vestibular rehabilitation training. The rehabilitation programme will include weight shifting, neck rotations, sit to stand exercises on padded mat, and head movements with eyes closed.
The intervention will be given for 3 minutes, 3 days a week for total 6 weeks of time period. Receives: Procedure: VESTIBULAR REHABILITATION TRAINING |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static Balance
The Vestibular Rehabilitation Benefit Questionnaire (VRBQ) is a validated tool used to measure balance 0 means no problem, 100 means severe problem
Measured: 6 weeks
Vertigo
DHI scale is used to assess vertigo.The questionnaire consists of 25 items with 3 responses YES= 4 points SOMETIMES = 2 points and NO = 0 points. The total score ranges from 0 to 100, higher score indicating self perceived handicap due to dizziness.
Measured: 6 weeks
Static Balance
CTSIB of Biodex is used to assess static balance and has 4 components. a) Firm surface with eyes open; (Mean value 0.44)test the integration of visual,somatosensory and vestibular inputs. All sensory systems are available for balance. b) Firm surface with eyes closed; (mean value 0.80)evaluate the reliance on somatosensory input for balance and visual input is eliminated.c) Foam surface with eyes open; (Mean value; 0.79) Test the ability to use visual and vestibular inputs for balance when somatosensory inputs is unreliable,unstable surface. d) Foam surface with eyes closed; (mean value 2.41) primarily challenges the vestibular system by eliminating visual input and providing unreliable somatosensory feedback. The total mean of these 4 components is 1.11.
Measured: 6 weeks
Dynamic balance
Functional Reach test will be used to assess dynamic balance
- Scoring:
- Distance in centimeters or inches is recorded.
- Normal values :
- <15 cm indicates a high fall risk in older adults
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start20 Jul 2024
- Primary completion1 Dec 2024
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Paroxysmal Positional VertigoStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06738823
- Sponsor's protocol ID
- FUI/CTR/2024/52
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Wii Fit Training in Comparison to Vestibular Rehabilitation Training on Balance in Patients With Benign Paroxysmal Postional Vertigo
- ClinicalTrials.gov ID
- NCT06738823
- Acronym / sponsor ID
- FUI/CTR/2024/52
- Conditions
- Benign Paroxysmal Positional Vertigo, Balance, Vertigo
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
THIS STUDY IS A RANDOMIZED CONTROL TRIAL AND THE PURPOSE OF THE STUDY IS TO DETERMINE THE EFFECT OF WIIFIT TRAINING IN COMPARISON TO VESTIBULAR REHAB TRAINING ON BALANCE IN PATIENTS WITH BENIGN PAROXYSMAL POSITIONAL VERTIGO
Detailed description
Effects of wiifit training will be assessed for balance and vertigo which includes the parameters of balance training.
Benign Paroxysmal Positional Vertigo patients aged 30-60 years The participants will be assessed through Vestibular Rehabilitation questionnaire (VRBQ), Dizziness handicap inventory (DHI), Functional reach test, Clinical test for sensory integration in balance and vertigo symptom scale.
Informed consent will be taken after which the participants will be recruited into two groups, where one group will receive wiifit training and other group will receive vestibular rehabilitation training.
Base-line and post-treatment measurement will be taken for analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group A | Experimental | Procedure: INTERVENTION GROUP : TRAINING WITH WIIFITThe participants will receive intervention through Wii fit training which includes games tight rope tension, ski slalom, penguin slide, table tilt, and heading for 6 total 6 weeks. 3 days per week session will be given for 30 minutes including 5-minutes warmup and cool down and 5 minutes of break in between to avoid fatigue. |
| Experimental group B | Active comparator | Procedure: VESTIBULAR REHABILITATION TRAININGThe participants will receive vestibular rehabilitation training. The rehabilitation programme will include weight shifting, neck rotations, sit to stand exercises on padded mat, and head movements with eyes closed. The intervention will be given for 3 minutes, 3 days a week for total 6 weeks of time period. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients diagnosed with benign paroxysmal positional vertigo.
- Aged 30-60 years.
- Ability to stand and walk independently.
- Male and Female
- Positive Dix Hallpike Test
Key exclusion criteria (5 listed)
- patients with history of vestibular surgery or cochlear implantation.
- Patients with history of seizures or epilepsy.
- patients with a pacemaker or implantable cardioverter-defibrillator(ICD).
- Patients with history of severe head injury or concussion within the past year.
- No other vestibular disorders or conditions that may affect balance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INTERVENTION GROUP : TRAINING WITH WIIFITRCT (RANDOMIZED CONTROL TRIAL) GROUP 1 : Wii FIT TRAINING TIGHT ROPE TENSION, SKI SLALOM, PENGUIN SLIDE, TABLE TILT GROUP 2 : VESTIBULAR REHABILITATION TRAINING WEIGHT SHIFTING, NECK ROTATIONS, SIT TO STAND EXERCISES ON PADDED MAT AND HEAD MOVEMENTS WITH EYES CLOSED. | Procedure or surgery | Experimental group A |
| VESTIBULAR REHABILITATION TRAININGWEIGHT SHIFTING, NECK ROTATIONS, SIT TO STAND EXERCISES ON PADDED MAT AND HEAD MOVEMENTS WITH EYES CLOSED. | Procedure or surgery | Experimental group B |
Primary outcome
Static Balance
Time frame: 6 weeks
The Vestibular Rehabilitation Benefit Questionnaire (VRBQ) is a validated tool used to measure balance 0 means no problem, 100 means severe problem
Vertigo
Time frame: 6 weeks
DHI scale is used to assess vertigo.The questionnaire consists of 25 items with 3 responses YES= 4 points SOMETIMES = 2 points and NO = 0 points. The total score ranges from 0 to 100, higher score indicating self perceived handicap due to dizziness.
Static Balance
Time frame: 6 weeks
CTSIB of Biodex is used to assess static balance and has 4 components. a) Firm surface with eyes open; (Mean value 0.44)test the integration of visual,somatosensory and vestibular inputs. All sensory systems are available for balance. b) Firm surface with eyes closed; (mean value 0.80)evaluate the reliance on somatosensory input for balance and visual input is eliminated.c) Foam surface with eyes open; (Mean value; 0.79) Test the ability to use visual and vestibular inputs for balance when somatosensory inputs is unreliable,unstable surface. d) Foam surface with eyes closed; (mean value 2.41) primarily challenges the vestibular system by eliminating visual input and providing unreliable somatosensory feedback. The total mean of these 4 components is 1.11.
Dynamic balance
Time frame: 6 weeks
Functional Reach test will be used to assess dynamic balance * Scoring: * Distance in centimeters or inches is recorded. * Normal values : * <15 cm indicates a high fall risk in older adults
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTERVENTION GROUP : TRAINING WITH WIIFIT and VESTIBULAR REHABILITATION TRAINING in people with Benign Paroxysmal Positional Vertigo and Balance, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MAHAM AKBAR, DPT (+92334-6406143, mahamakbarch25@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Balance (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.