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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04715282
Other study ID # IstinyeU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date February 2017

Study information

Verified date January 2021
Source Istinye University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Epley maneuver
Epley maneuver

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istinye University

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
one hour
Primary 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. one hour
Secondary Vertigo Symptom Scale (VSS) The total score ranges between 0 and 60 points, with higher scores indicating lower vertigo associated symptoms. one hour
Secondary Dizziness Handicap Inventory (DHI) The total score ranges between 0 and 100 points, with higher scores indicating lower quality of life. one hour
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