An interventional study of Epleys Maneuver and Semont-plus maneuver in Dizziness and Benign Paroxysmal Positional Vertigo (BPPV), sponsored by Foundation University Islamabad. Recruiting at 1 site in Pakistan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Foundation University Islamabad · Not applicable, Interventional, and Treatment
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..
OBJECTIVES:
The objectives of this study are:
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\<0.05).
Null Hypothesis:
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
Exclusion Criteria
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\'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:
226 studies on the registry are indexed under Dizziness; 56 are open to participants now.
This study's planned enrollment of 40 is close to the median of 43 across 170 interventional studies indexed under Dizziness.
Browse Dizziness studies →Foundation University Islamabad is the lead sponsor of 255 studies on the registry; 142 are open to participants now.
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Exclusion Criteria:
It includes participants receiving Epley's Maneuver combined with Brandt-daroff exercises for 6 weeks of treatment.
Procedure: Epleys Maneuver · Procedure: Brandt-Daroff exercises
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
* 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.
* 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.
* 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.
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.
Time frame: 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.
Time frame: 6 weeks
Plan to share: No
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Started Jul 2024 (actual). Primary completion is estimated for Dec 2024, 4 months after the start.
Of 82 non-industry interventional studies with no phase under Dizziness, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's planned 4 months is below that.
Counting every sponsor, half of 90 studies reached it within 20 months; a quarter within 8 and three quarters within 42.
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