- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06797141
Combined Effects of Vestibular Rehabilitation With Dual Task Training in Vestibular Disorders
Combined Effects of Vestibular Rehabilitation and Dual Task Training Exercises on Balance, Gait and Quality of Life in Patients With Vestibular Disorders
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 54600
- Fatima Memorial Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients complaining of dizziness for longer than 3 months
- Patients with history of at least 1 bout of dizziness per month
- Patients with history of at least 1 fall in previous 6 months
- Diagnosed Patients as having vestibular disorder by an otolaryngologist
- Mini Mental State Examination (MMSE) score greater than 24
Exclusion Criteria:
- Patients with Meniere disease and bilateral vestibular disorders
- Patients with central nervous system disorders, and psychiatric disorders
- Patients having visual impairment that could not be treated with lenses or glasses
- Dizziness not resulting from vestibular disorder or use of Medication for Dizziness
- Movement limitation due to orthopedic problems
- Those who were unable to sign informed consent form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Vestibular Rehabilitation and Dual Task Training and Traditional Physical Therapy
Group A will receive treatment session lasting for 1 hour including vestibular rehabilitation therapy for 30 minutes and Dual Task Training for 20 minutes along with routine physical therapy of 10 minutes.
Treatment session will be supervised by physical therapist and will be given 5 days per week for 8 weeks
|
Group A will receive treatment session lasting for 1 hour including vestibular rehabilitation therapy for 30 minutes and Dual Task Training for 20 minutes along with routine physical therapy of 10 minutes.
Treatment session will be given 5 days per week for 8 weeks.
Patients will be instructed to perform 2 sets of 5 repetition each Gaze Stability exercises: Horizontal and Vertical Head movements keep their eyes fixed on a stationary target, Following a slowly moving target keeping head still Balance Exercises:Maintain balance while performing neck rotations and shifting their weight forward, backward, and side to side.Sit to stand on chair Gait Training: Walking at varying speeds, walking forwards and backwards, sideways walking, walk in circles, and walking with horizontal and vertical head movements Dual Task exercises comprising of primary and secondary tasks Conventional Cawthorne Cooksey exercises :Up and down eye and Head movements, pick up things from ground, Walk up and down
|
|
Active Comparator: Vestibular Rehabilitation and Traditional Physical Therapy
Group B will receive treatment session lasting for 1 hour including vestibular rehabilitation therapy for 40 minutes along with routine physical therapy of 20 minutes.
Treatment session will be supervised by physical therapist and will be given 5 days per week for 8 weeks.
|
Group B will receive treatment session lasting for 1 hour including vestibular rehabilitation therapy for 40 minutes along with routine physical therapy of 20 minutes. Treatment session will be given 5 days per week for 8 weeks. Gaze Stability exercises: Horizontal and Vertical Head movements keep their eyes fixed on a stationary target, Following a slowly moving target keeping head still Balance Exercises:Maintain balance while performing neck rotations and shifting their weight forward, backward, and side to side.Sit to stand on chair Gait Training: Walking at varying speeds, walking forwards and backwards, sideways walking, walk in circles, and walking with horizontal and vertical head movements Conventional Cawthorne Cooksey exercises :Up and down eye and Head movements, pick up things from ground, Walk up and down |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go test
Time Frame: 8 week
|
The instrument is used to assess dynamic balance including pace, distance, mechanism of turn, type of chair and number of trials.
The time required to perform this test is measured.
If more than 12 sec is taken in the completion of this test then it indicates high risk of fall
|
8 week
|
|
Dynamic Gait Index
Time Frame: 8 week
|
Dynamic Gait Index (DGI) contains eight items measured on 4-point ordinal scale (3: Normal, 2: Mild Impairment, 1: Moderate impairment, 0: Severe Impairment).
|
8 week
|
|
Vestibular Rehabilitation Benefit Questionnaire
Time Frame: 8 week
|
The Vestibular Rehabilitation Benefit Questionnaire (VRBQ) is 22 items subjective tool used to evaluate vestibular symptoms and their impact on quality of life in vestibular disorders.
It is categorized into 3 subscales Dizziness and anxiety, Motion-provoked dizziness and Quality of life.
Its score interpretation indicates 0%: no deficit & 100%: significant deficit.
Score above 0% signifies the presence of symptoms, loss of function, or reduced quality of life
|
8 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dizziness Handicap Inventory
Time Frame: 8 week
|
It is a 25 item self-reported tool used to assess the level of disability experienced by individuals with dizziness, vertigo, or imbalance.
It evaluates the impact of dizziness on functional, emotional, and physical aspects of the individual's life.
It takes only 10 minutes to complete this tool.
Patients rate their perceived disability due to dizziness by responding to each question with "yes," "sometimes," or "no."
The answers are scored as follows: "No" = 0 points, "Sometimes" = 2 points, and "Yes" = 4 points.
A higher total score, out of a possible 100 points, indicates a greater level of perceived disability.
Patients scoring over 10 points should be referred for further evaluation.
|
8 week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hira Jabeen, PhD, Riphah International University
Publications and helpful links
General Publications
- Choi WY, Gold DR. Vestibular Disorders: Pearls and Pitfalls. Semin Neurol. 2019 Dec;39(6):761-774. doi: 10.1055/s-0039-1698752. Epub 2019 Dec 17.
- Aedo-Sanchez C, Riquelme-Contreras P, Henriquez F, Aguilar-Vidal E. Vestibular dysfunction and its association with cognitive impairment and dementia. Front Neurosci. 2024 Mar 27;18:1304810. doi: 10.3389/fnins.2024.1304810. eCollection 2024.
- Strupp M, Dlugaiczyk J, Ertl-Wagner BB, Rujescu D, Westhofen M, Dieterich M. Vestibular Disorders. Dtsch Arztebl Int. 2020 Apr 24;117(17):300-310. doi: 10.3238/arztebl.2020.0300.
- Staab JP. Persistent Postural-Perceptual Dizziness. Semin Neurol. 2020 Feb;40(1):130-137. doi: 10.1055/s-0039-3402736. Epub 2020 Jan 14.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
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
- REC/RCR & AHS/24/0257
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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