Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625281
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief 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
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Vestibular hypofunction can result in symptoms consisting of dizziness imbalance andor oscillopsia gaze and gait instability and impaired navigation and spatial orientation thus may negatively impact an individual39s 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 Epley39s 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 Epleys 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
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 Epley39s 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 Epleys 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 Epleys 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 Epley39s 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 Epleys maneuver combined with brandt-daroff exercises Versus Semont-plus maneuver combined with Brandt-Daroff exercises in patients with pc-BPPV plt005
Null Hypothesis
1 There will be no significant effect in the study groups in terms of Dizziness and Quality of life between Epleys maneuver combined with brandt-daroff exercises Versus Semont-plus maneuver combined with Brandt-Daroff exercises in patients with pc-BPPV pgt005
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 Menieres 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 Epley39s 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 Epleys 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
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 Epleys 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 Epley39s 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 Epleys maneuver combined with brandt-daroff exercises Versus Semont-plus maneuver combined with Brandt-Daroff exercises in patients with pc-BPPV plt005
Null Hypothesis
1 There will be no significant effect in the study groups in terms of Dizziness and Quality of life between Epleys maneuver combined with brandt-daroff exercises Versus Semont-plus maneuver combined with Brandt-Daroff exercises in patients with pc-BPPV pgt005
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 Menieres 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 Epley39s 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 Epleys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None