Benign Paroxysmal Positional VertigoBPPVNCT04715282
The Epley Maneuver Versus Cawthorne-Cooksey Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
A study testing Epley maneuver in people with Benign Paroxysmal Positional Vertigo, run by Istinye University.
Trial summary
Observation of the effects of Cawthorne-Cooksey exercises applied after the Epley maneuver on balance, vertigo symptoms, and quality of life in BPPV patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo
- What is being tested?
- Epley maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Effectiveness of the Epley Maneuver Versus Vestibular Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
Observation of the effects of Cawthorne-Cooksey exercises applied after the Epley maneuver on balance, vertigo symptoms, and quality of life in BPPV patients.
Read the 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.
- Conditions
- Benign Paroxysmal Positional Vertigo
- Being tested
- Epley maneuver
- Medical subject headings
- Benign Paroxysmal Positional Vertigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epley maneuverProcedure or surgery
Epley maneuver
| Study group | Role | What they receive |
|---|---|---|
| Epley maneuver | Other | 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. Receives: Procedure: Epley maneuver |
| Cawthorne-Cooksey exercises combined with the Epley maneuver | Other | 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. Receives: Procedure: Epley maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nintendo Wii Balance Board (WBB)
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.
Measured: one hour
Berg Balance Test (BBT)
The minimum score of the BBT is 0 and the total maximum score of the BBT is 56. Higher scores indicate better dynamic balance.
Measured: one hour
Secondary outcomes (2)
Vertigo Symptom Scale (VSS)
The total score ranges between 0 and 60 points, with higher scores indicating lower vertigo associated symptoms.
Measured: one hour
Dizziness Handicap Inventory (DHI)
The total score ranges between 0 and 100 points, with higher scores indicating lower quality of life.
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study startMar 2016
- Primary completionFeb 2017
- Study completionFeb 2017
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 Istinye UniversityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Habibe Serap Inal, Istinye University
- Investigators
- Ekin Taçalan, Principal investigator, Dr. Sami Ulus Maternity, Children Health and Diseases Education and Research HospitalH.Serap İnal, Principal investigator, Istinye University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715282
- Sponsor's protocol ID
- IstinyeU
- Acronym
- BPPV
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Epley Maneuver Versus Vestibular Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
- ClinicalTrials.gov ID
- NCT04715282
- Acronym / sponsor ID
- BPPV / IstinyeU
- Conditions
- Benign Paroxysmal Positional Vertigo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 20 Jan 2021 (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.
Observation of the effects of Cawthorne-Cooksey exercises applied after the Epley maneuver on balance, vertigo symptoms, and quality of life in BPPV patients.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epley maneuver | Other | Procedure: Epley maneuverThe 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. |
| Cawthorne-Cooksey exercises combined with the Epley maneuver | Other | Procedure: Epley maneuverAdditional 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Epley maneuverEpley maneuver | Procedure or surgery | Cawthorne-Cooksey exercises combined with the Epley maneuver, Epley maneuver |
Primary outcome
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.
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.
2 secondary outcomes
Vertigo Symptom Scale (VSS)
Time frame: one hour
Dizziness Handicap Inventory (DHI)
Time frame: one hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ekin Taçalan principal investigator
Dr. Sami Ulus Maternity, Children Health and Diseases Education and Research Hospital
H.Serap İnal principal investigator
Istinye University, Faculty of Health Sciences, Physiotherapy and Rehabilitation Department
Questions about this trial
What is this clinical trial studying?
A study testing Epley maneuver in people with Benign Paroxysmal Positional Vertigo, run by Istinye University.
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 3 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: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nintendo Wii Balance Board (WBB) (time frame: one hour). The study lists 2 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 20 Jan 2021.