NCT04469309

Brief Summary

This study is important as there are numbers of BPPV patients presenting to outpatient departments which needs more efficient techniques for management of BPPV. Talking about literature, there are numbers of studies done on different maneuvers but there is yet no study available which compares these maneuvers. So the purpose of this study is to compare these techniques to find which one is more effective in treating PC-BPPV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

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

April 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

April 14, 2020

Last Update Submit

March 6, 2021

Conditions

Vertigo, Paroxysmal

Keywords

Half-Somersault ExerciseBrandt-Daroff exercisePosterior CanalBenign Paroxysmal Positional Vertigo

Outcome Measures

Primary Outcomes (2)

  • Vestibular activities and participation measure

    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.The response range from none (0 points) ,moderate (2 points), severe (3 points) unable to do (4 points) to not applicable. The total score is obtained after calculating the average of the item scale values and excluding the not applicable item scale scores

    Change from Baseline dizziness and balance to 2 Weeks

  • Dix-Hall pike test

    Dix-Hall pike is the standard procedure for diagnosis of PC-BPPV. The Dix-Hallpike Test (DHT) is considered the gold standard assessment for the diagnosis of the vestibular disorder Benign Paroxysmal Positional Vertigo (BPPV). The Dix-Hallpike test involves rapidly moving the patient from a sitting position to "head hanging," where the patient's head is at least 10 degrees below horizontal.

    Change from Baseline dizziness to 2 Week

Secondary Outcomes (1)

  • Fall efficacy scale (FES)

    Change from Baseline dizziness to 2 Week

Study Arms (2)

Group I

EXPERIMENTAL

Group I will receive Brandoff Exercises

Other: Group I Brandt-Daroff Exercises

Group II

ACTIVE COMPARATOR

Group II will receive Somersault exercises

Other: Group II Half-Somersault Maneuver

Interventions

Group I Brandt-Daroff ExercisesOTHER

In group I Brandoff Exercises will be performed using standard method, in which the patient is in the sitting position on examination table, the patient moves into the lying position on the affected side on the shoulder, with the head angled upward with about 45. The patient stays in this for 30 s and then goes back to the sitting position, looks forward and remains in this position for 30 s as well. The patient repeats the same procedure for the other side, too. The patient performs this maneuver 2 times, twice a day. For total 9 days for 3 weeks. Pre, mid and post assessment.

Group I
Group II Half-Somersault ManeuverOTHER

In group II Half-Somersault Maneuver will be done, the patient performs this maneuver 2 times, twice a day. For total 9 days for 3 weeks.

Group II

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed Patients with PC-BPPV
  • Age group 25-50 years.
  • DHI Scale: 36-42 (moderate handicap)
  • Both gender
  • Duration of complaints: from the past 6 months

You may not qualify if:

  • Migraine related dizziness and Anxiety disorder
  • Other vestibular conditions are: Acoustic neuroma, Labyrinthitis, Vestibular hypo function, Meniere's disease.
  • Any cervical pathology,
  • CNS Pathology causing dizziness and vertigo
  • Other pathologies which may affect balance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HMC Hospital Peshawar

Peshawar, Khyber Pakhtunkha, 25000, Pakistan

Location

Related Publications (8)

  • Gupta AK, Sharma KG, Sharma P. Effect of Epley, Semont Maneuvers and Brandt-Daroff Exercise on Quality of Life in Patients with Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo (PSCBPPV). Indian J Otolaryngol Head Neck Surg. 2019 Mar;71(1):99-103. doi: 10.1007/s12070-018-1322-7. Epub 2018 Mar 30.

    PMID: 30906723BACKGROUND

  • Maranhao ET, Whitney SL, Maranhao-Filho P. Tumarkin-like phenomenon as a sign of therapeutic success in benign paroxysmal positional vertigo. Arq Neuropsiquiatr. 2018 Aug;76(8):534-538. doi: 10.1590/0004-282X20180073.

    PMID: 30231127BACKGROUND

  • Beeumen N Van. Faculteit Geneeskunde en Levenswetenschappen master in de revalidatiewetenschappen en de kinesitherapie Faculteit Geneeskunde en Levenswetenschappen master in de revalidatiewetenschappen en de kinesitherapie. 2018

    BACKGROUND

  • Zhang YX, Wu CL, Zhong FF, Ding CN. Evaluation of efficacies and recurrence rates of three self-treatment maneuvers for posterior semicircular canal benign paroxysmal positional vertigo. Int J Clin Exp Med. 2016;9(6):11780-7

    BACKGROUND

  • Kinne BL. Benign paroxysmal positional vertigo. Eye Mov Disord (Nystagmus Strabismus) Diagnosis, Manag Impact Qual Life. 2014;9(1):1-30.

    BACKGROUND

  • 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

  • Manayil John HG, John A. Efficacy of Epley'S Manoeuvre in Posterior Canal Benign Paroxysmal Positional Vertigo. J Evid Based Med Healthc. 2016;3(102):5624-7.

    BACKGROUND

  • Jaffar M, Ghous M, Ayaz M, Khan AA, Akbar A, Haleem F. Effects of Half-Somersault and Brandt-Daroff exercise on dizziness, fear of fall and quality of life in patients with posterior canal benign paroxysmal positional vertigo: A randomised control trial. J Pak Med Assoc. 2023 Jan;73(1):139-142. doi: 10.47391/JPMA.3333.

    PMID: 36842024DERIVED

MeSH Terms

Conditions

VertigoBenign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

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

Study Officials

  • Misbah Ghous, MSNMPT

    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

April 14, 2020

First Posted

July 14, 2020

Study Start

June 1, 2020

Primary Completion

October 31, 2020

Study Completion

October 31, 2020

Last Updated

March 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)