The Epley Maneuver Versus Cawthorne-Cooksey Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV) (BPPV)

• ClinicalTrials.gov Identifier: NCT04715282
• Recruitment Status: Completed
• First Posted: January 20, 2021
• Last Update Posted: January 20, 2021
• Sponsor: Istinye University
• Information provided by (Responsible Party): Habibe Serap Inal, Istinye University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Benign Paroxysmal Positional Vertigo	Procedure: Epley maneuver	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Effectiveness of the Epley Maneuver Versus Vestibular Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
• Actual Study Start Date: March 2016
• Actual Primary Completion Date: February 2017
• Actual Study Completion Date: February 2017

Arms and Interventions

Arm	Intervention/treatment
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.	Procedure: Epley maneuver; Epley maneuver
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.	Procedure: Epley maneuver; Epley maneuver

Outcome Measures

Primary Outcome Measures :

1. 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.

2. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. having posterior semicircular canal BPPV with upbeating-torsional nystagmus and positional vertigo as evaluated by the Dix-Hallpike Test
2. agreeing to undergo the Epley maneuver after that test
3. agreeing to participate in the study

Exclusion Criteria:

1. having history or symptoms of vestibular system disorders other than BPPV or central nervous system disorders causing dizziness
2. having cervical and/or lumbar pathology due to which the Epley maneuver could not be performed
3. having lower extremity pain or an operation that prevented standing and/or weight bearing
4. having anterior or horizontal canal BPPV
5. having previously undergone a vestibular rehabilitation program

Contacts and Locations

Sponsors and Collaborators

Istinye University

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

More Information

• Responsible Party: Habibe Serap Inal, Prof, Istinye University
• ClinicalTrials.gov Identifier: NCT04715282
• Other Study ID Numbers: IstinyeU
• First Posted: January 20, 2021
• Last Update Posted: January 20, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Sensation Disorders