Effects of Epleys Maneuver Versus Semont-Plus Maneuver Combined with Brandt-Daroff Exercises on Dizziness and Quality of Life in Benign Paroxysmal Positional Vertigo

NCT06625281 | Recruiting

• 1 other identifier: FUI/CTR/2024/30
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Vestibular hypofunction can result in symptoms consisting of dizziness, imbalance, and/or oscillopsia, gaze and gait instability, and impaired navigation and spatial orientation; thus, may negatively impact an individual\'s quality of life, and ability to perform activities of daily living. Benign paroxysmal positional vertigo (BPPV) is the most common peripheral vestibular disorder which occurs with changing of the positions lying down, rolling over, climbing stairs, or looking up and down. The typical symptoms include dizziness, loss of balance, nystagmus, and nausea, limiting the daily activities of life and functional capacity. Much research has been done to rule out the prime treatment for posterior canal-BPPV using vestibular rehabilitation therapy (VRT), Canalith repositioning maneuvers (CRM), and habituation exercises, but scarce literature renders the combination of maneuvers and exercises. The current study will be used to determine and compare the effects of Epley\'s maneuver Versus the Semont-Plus maneuver combined with Brandt-Daroff exercises on Dizziness and Quality of life in participants with pc-Benign paroxysmal positional vertigo. The participants having clinically diagnosed Posterior canal Benign paroxysmal positional vertigo (BPPV) will be selected in this study. The outcome measure will be the Dizziness Handicap Inventory (DHI) to assess the Dizziness in participants and Vestibular activities and the participation measure (VAP) will assess the Quality of life. For such a randomized control trial a sample of 40 participants will be taken with 20 participants in each group will be included in the study. One group will undergo Epley's Maneuver and Brandt-daroff exercises and the second group will receive Semont-plus maneuver and Brandt-daroff exercises. Scores will be taken again after intervention. The study will be conducted over 1 year at Fauji Foundation Hospital and Foundation University Islamabad. Participants of interest would be approached and explained about the research. Informed written consent will be taken first. Recruited participants will be allocated to either of the groups through a convenient sampling method. All outcome measurements would be performed first at baseline and then after the 6 weeks intervention period..

Conditions

Dizziness; Benign Paroxysmal Positional Vertigo (BPPV)

Keywords

PhysicalTherapy; Vestibular Rehabilitation Therapy; Benign Paroxysmal Positional Vertigo

Outcome Measures

Primary Outcomes (2)

• Dizziness

  Dizziness Handicap Inventory scale (DHI) is used to assess Dizziness and can be used therapeutically to monitor and adjust rehabilitation therapy.The DHI is a 25-item self-reported measure with three categories: functional, emotional, and physical.

  6 weeks

• Quality of Life

  Change in the health related quality of life using Vestibular activities and participation measure (VAP) assesses the effect of dizziness on quality of life and activities of daily living.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.

  6 weeks

Study Arms (2)

Interventional Group A

ACTIVE COMPARATOR

It includes participants receiving Epley's Maneuver combined with Brandt-daroff exercises for 6 weeks of treatment.

Procedure: Epleys Maneuver; Procedure: Brandt-Daroff exercises

Interventional Group B

EXPERIMENTAL

This group involves participants receiving Semont-Plus Maneuver along with Brandt-daroff exercises for a period of 6 weeks.

Procedure: Semont-plus maneuver; Procedure: Brandt-Daroff exercises

Interventions

Epleys Maneuver PROCEDURE

* The patient begins in an upright sitting posture, with the legs fully extended and the head rotated 45 degrees towards the affected side. * The patient is then quickly and passively forced down backwards by the therapist performing the treatment into a supine position with the head held approximately in a 30-degree neck extension * The therapist observes the patient's eyes for "primary stage" nystagmus. The patient remains in this position for 1-2 minutes. * The patient's head is then turned 90 degrees to the opposite direction so that the unaffected ear faces the ground, for 1-2 minutes. * Keeping the head and neck in a fixed position relative to the body, the individual rolls onto their shoulder, rotating the head another 90 degrees in the direction they are facing. The patient is now looking downwards at a 45-degree angle. * The eyes should be immediately observed by the therapist for "secondary stage" nystagmus. The patient remains in this position for 1-2 minutes.

Interventional Group A

Semont-plus maneuver PROCEDURE

* The Semont-plus maneuver includes the upright position with turning of the head by 45° toward the non-affected side. * Then movement of the body by 150° toward the affected side, which moves the otoconia further in the direction in which they should move and since the clot is beyond the vertex, the movement of body by 240° moves the clot into the direction of the vestibulum.

Interventional Group B

Brandt-Daroff exercises PROCEDURE

* Patient sits on the edge of bed. and lies down onto the side that causes dizziness to increase. Look towards the ceiling. Stay in this position for 2 minutes. * Sits upright and then wait for 30 seconds. * Moves rapidly to the opposite side for 2 minutes.

Interventional Group A; Interventional Group B

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both genders
• Positive Dix Hallpike test.
• Patients diagnosed with Posterior canal Benign Paroxysmal Positional Vertigo.
• Patients with recurrent episodes of dizziness.
• Age group 20-65.
• Positive Dix Hallpike Test

You may not qualify if:

• Dix Hallpike test negative.
• DHI Scale: 54+ Severe
• Trauma
• Ankylosing spondylitis
• Cervical pathology-related dizziness
• Spinal cord injury
• Carotid stenosis
• Other Vestibular pathologies (Meniere's disease, Vestibular hypofunction, Labyrinthitis

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University College of Physical Thrapy

Islamabad, 44000, Pakistan

RECRUITING

MeSH Terms

Conditions

Dizziness; Benign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vertigo; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Nervous System Diseases

Central Study Contacts

MARWA JAVED, DPT

CONTACT

+923209502800; marwaa.javed@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will be kept unaware of which group they will be allocated and type of the intervention they will receive, whereas the investigator will be aware regarding the allocation and type of the intervention given to the participants. Single blinding is used in this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: July 20, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 20, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)