Clinical trial NCT06625281: Effects of Epleys Maneuver Versus Semont-Plus Maneuver Combined with Brandt-Daroff Exercises on Dizziness and Quality of Life in Benign Paroxysmal Positional Vertigo
Official title: Effects of Epleys Maneuver Versus Semont-Plus Maneuver Combined with Brandt-Daroff Exercises on Dizziness and Quality of Life in Benign Paroxysmal Positional Vertigo;
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dizziness
Benign Paroxysmal Positional Vertigo (BPPV)
Keywords: PhysicalTherapy
Vestibular Rehabilitation Therapy
Benign Paroxysmal Positional Vertigo
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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\&#39;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\&#39;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..

Detailed description: OBJECTIVES:

The objectives of this study are:

1. To determine the Effects of Semont-Plus Maneuver combined with Brandt-Daroff exercises on Dizziness and Quality of life in patients with pc-Benign paroxysmal positional vertigo (BPPV) 2-To determine the Effects of Epley's Maneuver combined with Brandt-Daroff exercises on dizziness and Quality of life in patients with pc-Benign paroxysmal positional vertigo (BPPV) 3-To compare the effects of Epley\&#39;s maneuver combined with Brandt-daroff exercises with the effects of Semont plus maneuver combined with Brandt-daroff exercises on Dizziness and Quality of life in patients with pc-Benign paroxysmal positional vertigo (BPPV)

HYPOTHESIS:

Alternate Hypothesis:

There will be a significant effect in the study group in terms of Dizziness and Quality of life between Epley's maneuver combined with brandt-daroff exercises Versus Semont-plus maneuver combined with Brandt-Daroff exercises in patients with pc-BPPV (p\&lt;0.05).

Null Hypothesis:

1. There will be no significant effect in the study groups in terms of Dizziness and Quality of life between Epley's maneuver combined with brandt-daroff exercises Versus Semont-plus maneuver combined with Brandt-Daroff exercises in patients with pc-BPPV (p\&gt;0.05).

Research Design: Experimental study. Randomized Control Trial

Clinical setting: ENT Department, Fauji Foundation Hospital and Treatment room FUCP.

Study duration: 6 months

Selection Criteria:

Inclusion Criteria

1. Both genders
2. Positive Dix Hallpike test.
3. Patients diagnosed with Posterior canal Benign Paroxysmal Positional Vertigo.
4. Patients with recurrent episodes of dizziness.
5. Age group 20-65.
6. Positive Dix Hallpike Test

Exclusion Criteria

1. Dix Hallpike test negative.
2. DHI Scale: 54+ Severe
3. Trauma
4. Ankylosing spondylitis
5. Cervical pathology-related dizziness
6. Spinal cord injury
7. Carotid stenosis
8. Other Vestibular pathologies (Meniere's disease, Vestibular hypofunction, Labyrinthitis

Sampling technique: Convenience Sampling

Outcome Measures:

Data will be collected on Demographics and general information. Dizziness will be assessed through the Dizziness Handicap Inventory (DHI) and Quality of life will be recorded with a Vestibular assessment and participation measure (VAP).

Experimental Group (A) = This group will receive Semont-Plus Maneuver combined with Brandt-daroff exercises interferential therapy and strengthening exercises and their outcomes will be measured at baseline and at the end of 6 weeks of treatment.

Control group (B) =This group will undergo Epley\&#39;s maneuver combined with Brandt-daroff exercises their outcomes will be observed at the baseline and then after treatment of 06 weeks.

Data analysis techniques:

The data will be analyzed through SPSS 21 and Data will be analyzed based on the study design chosen which is a random control experimental study within the community.

A printed questionnaire will be provided to the patients after obtaining written consent and providing adequate explanation regarding the study, after which the data will be presented in the form of graphs or tables.

Significance of the study:

1. Semont-Plus maneuver is a modified form of the Semont maneuver which has been more effective for posterior canal-related vertigo. It is important to find more evidence regarding the Semont-plus maneuver and Brandt-daroff habituation exercises. The combination of this maneuver with Brandt-Daroff exercises will have a remarkable effect on dizziness and thus improve the quality of life of the patients.
2. This study will provide valuable data regarding the comparison of Epley's Maneuver and Semont Maneuver along with their combination with Brandt-daroff exercises.
3. This study will provide awareness and valuable literature regarding the comparison and combination of maneuvers and exercises. Scarce literature is present regarding the combination of vestibular maneuvers and exercises.
4. An awareness for the health care community to use a new technique of combination. The maneuvers and exercises are quick to perform and can be a part of clinical and emergency conditions.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Dizziness
timeFrame: 6 weeks
measure: Quality of Life
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University College of Physical Thrapy
Study officials:
References: