NCT05575362

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2022

Completed
17 days until next milestone

Study Start

First participant enrolled

August 10, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 12, 2022

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

3 months

First QC Date

July 24, 2022

Last Update Submit

December 9, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    Change from baseline, to 3rd session, 6th session and after 1 month

Secondary Outcomes (1)

  • Berg balance scale

    Change from baseline, to 3rd session, 6th session and after 1 month

Study Arms (2)

Epley Manuver group

EXPERIMENTAL

Group A is Experimental group will receive Epley's maneuver and Cawthorne Cooksey exercise for two weeks.

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.

Other: Group B

Interventions

Group AOTHER

Group A will receive Epleys maneuver and Cawthorne Cooksey exercise for two weeks.

Epley Manuver group
Group BOTHER

Group B will receive Half Somersault maneuver along with Cawthorne Cooksey exercise for two weeks.

half somersault group

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misbah

Islamabad, Punjab Province, 46000, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 30013505BACKGROUND
  • Desai 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.

    BACKGROUND

Study Officials

  • Misbah Ghous, MS

    Riphah International University Islamabad

    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
SPONSOR

Study Record Dates

First Submitted

July 24, 2022

First Posted

October 12, 2022

Study Start

August 10, 2022

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

December 12, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations