- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06738823
Effect of Wii Fit Training in Comparison to Vestibular Rehabilitation Training on Balance in Patients With Benign Paroxysmal Postional Vertigo
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: MAHAM AKBAR, DPT
- Phone Number: +92334-6406143
- Email: mahamakbarch25@gmail.com
Study Locations
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Islamabad, Pakistan, 44000
- Recruiting
- Foundation University College of Physical Therapy
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Contact:
- SANA KHALID, MS-NMPT
- Phone Number: +92344-4218174
- Email: sana.khalid@fui.edu.pk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group A
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. |
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.
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Active Comparator: Experimental group B
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. |
WEIGHT SHIFTING, NECK ROTATIONS, SIT TO STAND EXERCISES ON PADDED MAT AND HEAD MOVEMENTS WITH EYES CLOSED.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Static Balance
Time Frame: 6 weeks
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The Vestibular Rehabilitation Benefit Questionnaire (VRBQ) is a validated tool used to measure balance 0 means no problem, 100 means severe problem
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6 weeks
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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.
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6 weeks
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Static Balance
Time Frame: 6 weeks
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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.
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6 weeks
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Dynamic balance
Time Frame: 6 weeks
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Functional Reach test will be used to assess dynamic balance
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6 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUI/CTR/2024/52
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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