NCT04715282

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
Last Updated

January 20, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

January 12, 2021

Last Update Submit

January 14, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Vertigo Symptom Scale (VSS)

    one hour

  • Dizziness Handicap Inventory (DHI)

    one hour

Study Arms (2)

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.

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.

Procedure: Epley maneuver

Interventions

Epley maneuver

Cawthorne-Cooksey exercises combined with the Epley maneuverEpley maneuver

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

VertigoVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 20, 2021

Study Start

March 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

January 20, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share