BPPVNCT05575362
Comparison of Epley Maneuver and COW Thorne Cooksey Exercise With Half Somersault Maneuver in BPPV
A study testing Group A and Group B in people with BPPV, run by Riphah International University at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- BPPV
- What is being tested?
- Group A and Group B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Aug 2022to 31 Oct 2022
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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 .
- Conditions
- BPPV
- Being tested
- Group A, Group B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AOther
Group A will receive Epleys maneuver and Cawthorne Cooksey exercise for two weeks.
Group BOther
Group B will receive Half Somersault maneuver along with Cawthorne Cooksey exercise for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| Epley Manuver group | Experimental | Group A is Experimental group will receive Epley's maneuver and Cawthorne Cooksey exercise for two weeks. Receives: Other: Group A |
| half somersault group | Active comparator | Group B is Control group will receive Half somersault maneuver and Cawthorne Cooksey exercise for two weeks. Receives: Other: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dizziness Handicap Inventory
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
Measured: Change from baseline, to 3rd session, 6th session and after 1 month
vestibular activity participation scale
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.
Measured: Change from baseline, to 3rd session, 6th session and after 1 month
Secondary outcomes (1)
Berg balance scale
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.
Measured: Change from baseline, to 3rd session, 6th session and after 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start10 Aug 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BPPVStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Misbah Ghous, MS, Principal investigator, Riphah International University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575362
- Sponsor's protocol ID
- zarlish
- Status last verified
- Dec 2022
- First submitted
- 24 Jul 2022
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30013505Desai 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Epley Maneuver and COW Thorne Cooksey Exercise With Half Somersault Maneuver in Patients of BPPV
- ClinicalTrials.gov ID
- NCT05575362
- Acronym / sponsor ID
- zarlish
- Conditions
- BPPV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 12 Oct 2022 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epley Manuver group | Experimental | Other: Group AGroup A is Experimental group will receive Epley's maneuver and Cawthorne Cooksey exercise for two weeks. |
| half somersault group | Active comparator | Other: Group BGroup B is Control group will receive Half somersault maneuver and Cawthorne Cooksey exercise for two weeks. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • Patients with Posterior canal BPPV.
Key exclusion criteria (7 listed)
- • Migraine related dizziness and Anxiety disorder
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 |
|---|---|---|
| Group AGroup A will receive Epleys maneuver and Cawthorne Cooksey exercise for two weeks. | Other | Epley Manuver group |
| Group BGroup B will receive Half Somersault maneuver along with Cawthorne Cooksey exercise for two weeks. | Other | half somersault group |
Primary outcome
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
vestibular activity participation scale
Time frame: Change from baseline, to 3rd session, 6th session and after 1 month
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.
1 secondary outcome
Berg balance scale
Time frame: Change from baseline, to 3rd session, 6th session and after 1 month
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 12 Dec 2022.
- Background: PubMed 30013505Chen 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.
- BackgroundDesai 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.
- Individual participant dataSharing planned: No
Related trials for BPPV
Recruiting
Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
Stroke
Not yet recruiting
Epley Versus Semont-plus Maneuver for Benign Paroxysmal Positional Vertigo
Benign Paroxysmal Positional Vertigo (BPPV)
Enrolling by invitationObservational study
Comparison of Two Mechanical Rotation Chairs With Diagnostics of Benign Paroxysmal Positional Vertigo.
Benign Paroxysmal Positional Vertigo (BPPV)
Not yet recruiting
The Effect of Chewing Gum on Dizziness in Patients Diagnosed With Posterior Canal Benign Paroxysmal Positional Vertigo in the Emergency Department
Vertigo Benign Positional, Dizziness
Active, not recruiting
Benign Paroxysmal Positional Vertigo With and Without Vestibular Hypofunction: Protocol for an Integrated Home-Based Exercise With Self-Managed Education Programme
Benign Paroxysmal Positional Vertigo (BPPV), Vestibular Hypofunction
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.
Misbah Ghous, MS principal investigator
Riphah International University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A and Group B in people with BPPV, run by Riphah International University at 1 site in Pakistan.
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 5 inclusion and 7 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 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Dizziness Handicap Inventory (time frame: Change from baseline, to 3rd session, 6th session and after 1 month). 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?
On the ClinicalTrials.gov record for NCT05575362, which also lists 2 linked publications.
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 12 Dec 2022.