- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04715282
The Epley Maneuver Versus Cawthorne-Cooksey Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV) (BPPV)
Effectiveness of the Epley Maneuver Versus Vestibular Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Objective:
To observe the efficacy of Cawthorne-Cooksey exercises applied after the Epley maneuver on balance, vertigo symptoms, and quality of life in patients with posterior canal BPPV.
Study Design:
Single-blind randomized controlled study
Sample Size:
Thirty-six patients were recruited in the study and were randomized equally into Epley maneuver (EpleyM) and Epley maneuver and exercise (EpleyM&Exe) groups.
Study Method:
All patients were treated with the Epley maneuver, while CawthorneCooksey exercises were given to the EpleyM&Exe group as home exercises for 6 weeks. Static and dynamic balance, vertigo and associated symptoms, and quality of life were assessed with the Nintendo Wii Balance Board, Berg Balance Test, Vertigo Symptom Scale, and Dizziness Handicap Inventory, respectively. The assessments were repeated at the 1st, 3rd, and 6th weeks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- having posterior semicircular canal BPPV with upbeating-torsional nystagmus and positional vertigo as evaluated by the Dix-Hallpike Test
- agreeing to undergo the Epley maneuver after that test
- agreeing to participate in the study
Exclusion Criteria:
- having history or symptoms of vestibular system disorders other than BPPV or central nervous system disorders causing dizziness
- having cervical and/or lumbar pathology due to which the Epley maneuver could not be performed
- having lower extremity pain or an operation that prevented standing and/or weight bearing
- having anterior or horizontal canal BPPV
- having previously undergone a vestibular rehabilitation program
Study Plan
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 |
---|---|
Other: Epley maneuver
The Epley maneuver was performed for all patients (both EpleyM and EpleyM&Exe groups) included in this study until nystagmus had disappeared in each position.
If nystagmus/vertigo was not seen, the Epley maneuver was not performed for patients at the 1st, 3rd, and 6th week assessments.
|
Epley maneuver
|
Other: Cawthorne-Cooksey exercises combined with the Epley maneuver
Additional Cawthorne-Cooksey exercises were prescribed to the EpleyM&Exe group.
The physiotherapist explained and demonstrated the exercises to each patient and the patients practiced the exercises until they performed them correctly.
Then the exercises were prescribed twice a day and repeated 10 times for 6 weeks as a home exercise program.
|
Epley maneuver
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nintendo Wii Balance Board (WBB)
Time Frame: one hour
|
COP displacement on double leg with eyes open/closed (%): Lower scores (approaching 50%) indicate better static balance. Frontal plane stability on dominant leg with eyes open/closed (%): The total score ranges between 0 and 100%. Higher scores indicate better static balance. |
one hour
|
Berg Balance Test (BBT)
Time Frame: one hour
|
The minimum score of the BBT is 0 and the total maximum score of the BBT is 56.
Higher scores indicate better dynamic balance.
|
one hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vertigo Symptom Scale (VSS)
Time Frame: one hour
|
The total score ranges between 0 and 60 points, with higher scores indicating lower vertigo associated symptoms.
|
one hour
|
Dizziness Handicap Inventory (DHI)
Time Frame: one hour
|
The total score ranges between 0 and 100 points, with higher scores indicating lower quality of life.
|
one hour
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ekin Taçalan, Dr. Sami Ulus Maternity, Children Health and Diseases Education and Research Hospital
- Principal Investigator: H.Serap İnal, Istinye University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- IstinyeU
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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