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Clinical Trials/NCT07267988
NCT07267988RecruitingNot Applicable

Additional Effects Of Brandt-Daroff Exercises With GANS Maneuver On Dizziness And Quality Of Life In Patients With BPPV

Foundation University Islamabad2 sites in 1 country30 target enrollmentStarted: September 13, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
30
Locations
2
Primary Endpoint
Dizziness

Study Overview

Brief Summary

Benign Paroxysmal Positional Vertigo (BPPV) is the most common cause of recurrent vertigo, with a lifetime prevalence of about 2.4% and a yearly incidence of roughly 0.6%. It results from displaced otoconia within the semicircular canals and is especially common in older adults. BPPV leads to brief, position-provoked episodes of vertigo, dizziness, and imbalance, and reduced quality of life. Although canalith-repositioning maneuvers are highly effective, recurrence is common, emphasizing the need for supportive and adjunctive management strategies.This randomized controlled trial will evaluate the Additional Effects OF Brandt-Daroff Exercise With GANS Maneuver On dizziness And Quality of Life In Patients with BPPV. Thirty patients with BPPV will be recruited at Fauji Foundation Hospital and screened using the Dizziness Handicap Inverntory Scale(DHI) and Vestibular Activities and Participation measure(VAP). Participants will be randomized into two groups: (1) Reciving GANS Manuever Alone (2) GANS Manuever with Brandt-Daroff Exercises(3 sessions per week/40minutes). Dizziness will be assessed using the Dizziness Handicap Inverntory Scale(DHI) , quality of life using the Activities and Participation Measure(VAP) Scale. Outcome measures will be recorded at baseline and post-intervention. Ethical approval will be obtained from FUMC ERC, and data will be analyzed using SPSS v.22.

Detailed Description

Benign Paroxysmal Positional Vertigo (BPPV) is a common and disabling vestibular disorder, affecting approximately 2.4% of individuals during their lifetime and accounting for nearly 20-30% of vertigo cases in clinical settings. It is caused by the displacement of otoconia into the semicircular canals, leading to brief episodes of vertigo and dizziness, that significantly disrupt daily activities and reduce quality of life. The high prevalence of BPPV is associated with increased risks of falls, functional limitations, and recurrent episodes. Although canalith repositioning maneuvers serve as the primary treatment, recurrence rates remain substantial, underscoring the need for adjunctive therapeutic approaches that address persistent vertigo and improve overall functional outcomes.This study aims to investigate the additional effects GANS maneuver and Brandt-Daroff exercise on dizziness reduction, and quality of life improvement, in BPPV Patients .A randomized controlled trial will be conducted with participants diagnosed with BPPV.This study will be a non blinded, randomized controlled trial with two groups: the intervention group, which will receive GANS Maneuver with Brandt-Daroff Exercises, and the control group, which will receive GANS Maneuver alone. The intervention will last for six weeks, with participants attending two 40-minute sessions per week. A total of 30 individuals with BPPV will be recruited and randomly assigned to one of the two groups. The Dizziness Handicap Inventory Scale(DHI) will be used to screen for dizziness. Quality of life will be measured using the Vestibular and Participation Scale(VAP).The study will be conducted over a period of 1 year at Fauji Foundation Hospital. Ethical approval will be obtained from FUMC ERC. Recruited participants will be allocated to either group through a random sampling method. Outcome measurements will be taken at baseline and again after the 6-week intervention period. Individuals meeting the inclusion criteria will be selected, and written informed consent will be obtained after explaining the study's purpose. Data will be entered and analyzed on SPSS v. 22.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosed Patients of Benign Paroxysmal Vertigo (BPPV)
  • Age between 18-60
  • Acute and Chronic BPPV Patients
  • Positive Dix-Hallpike Test
  • DHI Scale: Mild-Severe (0-100)

Exclusion Criteria

  • Patients with a history of vestibular surgery or cochlear
  • Patients with a history of seizures or epilepsy
  • Patients with a pacemaker or implantable cardioverter-defibrillator (ICD)
  • Patients with a history of severe head injury or concussion within the past year
  • No other vestibular disorders or conditions that may affect balance (e.g., Meniere's disease, labyrinthitis
  • No musculoskeletal or neurological conditions that may affect balance (e.g., stroke, Parkinson's disease)

Outcomes

Primary Outcomes

Dizziness

Time Frame: 6 weeks

Dizziness Handicap Inventory Scale(DHI): 25 Items (scoring16-54) where 16-34 = Mild handicap , 36-52 = moderate handicap , 52+ = severe handicap

Quality Of Life In BPPV patients

Time Frame: 6 weeks

Vestibular Activities and Participation Scale (VAP): A 34-item, (1-4 score) , 1 = mild limitations, 2 = moderate limitation, and 3 = severe limitations, 4=extreme limitation

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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