- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05575362
Comparison of Epley Maneuver and COW Thorne Cooksey Exercise With Half Somersault Maneuver in BPPV
December 9, 2022 updated by: Riphah International University
Comparison of Epley Maneuver and COW Thorne Cooksey Exercise With Half Somersault Maneuver in Patients of BPPV
Benign paroxysmal positional vertigo is a most common cause of peripheral vestibular pathology.
BPPV may be characterized by sudden changes in the position of the head, such as lying down on one or both sides, looking right or left side .it
can occurs either due to canalithiasis or cupulolithiasis, displacement of otoconia or calcium carbonate crystal into fluid filled semicircular canal which sends false signals to central nervous system causing nystagmus and vertigo.
BPPV is a self limiting condition characterized by episodic vertigo and nystagmus of brief duration which resolves spontaneously.
Study Overview
Detailed Description
BPPV is treated using canalith repositioning procedures, the most common of which is the Epley's maneuver (EM), half somersault exercises, Brandt Daroff exercise, Semont maneuver, vestibular habituation exercises, balance and eye exercises.
In addition to the maneuvers, simple daily program Caw Thorne -Cooksey exercise were instructed to perform by participants to ensure clearance of the otoconia and facilitate full resolution of vertigo symptoms.
These vestibular exercises involve eye, head and body movements in different directions to provoke vestibular system.
It promote recovery and reduce symptoms of dizziness, unsteadiness , balance impairment and improves activity of daily living.
The Otolaryngologist Caw Thorne and Cooksey develops this exercise programme in order to rehabilitate the soldier with chronic dizzeness and brain trauma.
A study concluded by Ramanathan et al 2019 that Caw Thorne -Cooksey habituation exercises along with Brandt-Daroff exercises is more effective in treatment of vertigo among posterior canal BPPV subject .
Caw Thorne and Cooksey exercise improves balance in old age individuals.
Caw Thorne and Cooksey exercise are habituation exercise.
These movements provoke patients symptoms and patients repeat these exercises until unless they no longer respond to adverse effects of these exercises .
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Punjab
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Islamabad, Punjab, Pakistan, 46000
- Misbah
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Patients with Posterior canal BPPV.
- Patients with recurrent episodes of vertigo for 3 months.
- Age group 35-65years.
- Dix-Hall-pike test positive.
- Both gender
Exclusion Criteria:
• Migraine related dizziness and Anxiety disorder
- Dix hallpike test negetive
- Other vestibular conditions are: Acoustic neuroma, Labyrinthitis, Vestibular hypofunction, Meniere's disease.
- Any cervical pathology,
- Visual impairment,
- CNS Pathology:causing dizziness and vertigo
- Other pathologies which may affect balance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Epley Manuver group
Group A is Experimental group will receive Epley's maneuver and Cawthorne Cooksey exercise for two weeks.
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Group A will receive Epleys maneuver and Cawthorne Cooksey exercise for two weeks.
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Active Comparator: half somersault group
Group B is Control group will receive Half somersault maneuver and Cawthorne Cooksey exercise for two weeks.
|
Group B will receive Half Somersault maneuver along with Cawthorne Cooksey exercise for two weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dizziness Handicap Inventory
Time Frame: Change from baseline, to 3rd session, 6th session and after 1 month
|
The DHI is a 25-item self-report questionnaire that quantifies the impact of dizziness on daily life by measuring self-perceived handicap.
Item scores are summed.
There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0
|
Change from baseline, to 3rd session, 6th session and after 1 month
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vestibular activity participation scale
Time Frame: Change from baseline, to 3rd session, 6th session and after 1 month
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The Vestibular Activities and Participation Measure (VAP) is a 34-item self-report questionnaire that asks the individual to evaluate the effect of dizziness and/or balance problems on their ability to perform activity and participation tasks.
|
Change from baseline, to 3rd session, 6th session and after 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Berg balance scale
Time Frame: Change from baseline, to 3rd session, 6th session and after 1 month
|
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.
It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.
It does not include the assessment of gait.
|
Change from baseline, to 3rd session, 6th session and after 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Misbah ghous, MS, Riphah International University Islamabad
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Desai DS, Chauhan AS, Trivedi MN. Role of modified Epley's maneuver and Brandt-Daroff exercises in treatment of posterior canal BPPV: a comparative study. Int J Physiother Res. 2015;3(3):1059-64.
- Chen CC, Cho HS, Lee HH, Hu CJ. Efficacy of Repositioning Therapy in Patients With Benign Paroxysmal Positional Vertigo and Preexisting Central Neurologic Disorders. Front Neurol. 2018 Jun 29;9:486. doi: 10.3389/fneur.2018.00486. eCollection 2018.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 10, 2022
Primary Completion (Actual)
October 31, 2022
Study Completion (Actual)
October 31, 2022
Study Registration Dates
First Submitted
July 24, 2022
First Submitted That Met QC Criteria
October 10, 2022
First Posted (Actual)
October 12, 2022
Study Record Updates
Last Update Posted (Estimate)
December 12, 2022
Last Update Submitted That Met QC Criteria
December 9, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- zarlish
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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