Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05828433
Status:
COMPLETED
Last Update Posted:
2023-04-25
First Post:
2023-03-21
Brief Title:
Effect of Epley-Canalith Repositioning Procedure and Vestibular Rehabilitation Therapy in Diabetic Patients With BPPV
Sponsor:
Dr Mohammad Abu Shaphe
Organization:
University of Jazan
Study Overview
Official Title:
Effectiveness of Epley-Canalith Repositioning Procedure Versus Vestibular Rehabilitation Therapy in Diabetic Patients With Benign Paroxysmal Positional Vertigo A Randomized Trial
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Benign paroxysmal positional vertigo BPPV is a common inner ear disorder characterized by brief episodes of vertigo caused by changes in head position The condition can cause significant func-tional impairment and reduced quality of life BPPV is especially common among diabetic patients The Epley-Canalith Repositioning Procedure CRP and Vestibular Rehabilitation Therapy VRT are two commonly used interventions for the treatment of BPPV The objective of this paper is to determine the effective therapy among Epley-Canalith Repositioning Procedure and Vestibular Rehabilitation for improving balance and posture control in Diabetic patients with Benign Parox-ysmal Positional Vertigo Thirty subjects with Diabetes Mellitus Type 2 suffering from Benign Paroxysmal Positional Vertigo BPPV were recruited for the study and randomly assigned to groups A and B underwent Canalith Repositioning Procedure and Vestibular Rehabilitation Therapy respectively The outcome measures of the study were Vertigo Symptom Scale- Short Form VSS-sf score and Berg Balance Scale Form BBS score assessed at pre -treatment pre and 4 weeks post treatment post
Detailed Description:
Research ObjectivesTo determine the effective therapy among Epley-Canalith Repositioning Procedure and Vestibular Rehabilitation for improving balance and posture control in Diabetic patients with Benign Paroxysmal Positional Vertigo
Methods Thirty subjects were recruited for the proposed study on the basis of inclusion and exclusion criteria Patients who are diagnosed with posterior canal BPPV by ENT physician and diabetes by the physician through laboratory investigations both male and female aged between 20 to 70 years Positive Dix -Hallpike test Nystagmus lasting less than 60 seconds willing to participate in the study and with a minimum score of 2556 in Berg Balance Scale were included Whereas patients taking antivertigo drugs who had been treated for similar vertigo experience disease of different origin that may cause vertigo like migraine multiple sclerosis stroke traumatic brain injury if CRP has been done before other causes of peripheral vertigo such as Menieres disease vestibular neuritis labrynthitis and perilymphatic fistula pathologies contraindicated for Dix- hallpike maneuver like prolapse intervertebral disk cervical spine instability cervical myelopathy previous cervical spine surgery were excluded Those meeting the criteria will be randomized into Group A ie Epley-Canalith Repositioning and Group B ie Vestibular Rehabilitation Therapy through lottery method
Interventions In Group A control group the affected posterior canal it is the posterior semi-circular canal of the under most ear when the classic nystagmus is provoked was predetermined by Dix-Hallpike test The time of latency and duration of induced nystagmus was recorded by an assistant using stopwatch This provided an estimate of the time required for the canalith bolus trough 90
Procedure will be explained to the patients before the intervention The patients will be asked to keep the eyes open to watch the nystagmus The patient will be seated length wise on the examination table in search a way that when brought to the Hallpike position the head should extend beyond the end of the table An assistant was asked to stand by the side of affected canal
Step 1 The patient was brought down with the head turned 45 towards the affected canal as in Hallpike test The neck was extended
Step 2 The head was rotated 90 towards the unaffected side The neck will be extended Step 3 The head and body was rotated by further 90 from the previous positions now face down The neck was in neutral position Step 4 The patient was brought up in siting position while the head was kept turning towards the unaffected side Step 5 The head was turned forward and the chin will be kept 20 down for a minute
Since all the patients were having nystagmus lasting for less than 60 seconds each position was maintained for 60 second The procedure will be repeated until no nystagmus will be observed during the last cycle or until no progress is apparent in the last two cycles
The intervention will be given for approximately 15min for 2 times in a week for 4 weeks
Before going home all the patients were given instructions
The patients were asked to wait for 10 minutes after the maneuver is performed before going home
Patients were instructed not to lie supine to keep their head at 45 reclining positions while sleeping for 2 days
All patients were asked to avoid provoking head positions like bending over looking up or down for 7 days following the procedure
Group B received Vestibular Rehabilitation Therapy which consisted of habituation exercises gaze stability and balance training Habituation exercises The patient were instructed to sit on the side the examining couch Then he was warned that the exercises could worsen the frequency and intensity of vertigo in the beginning but that they should not alarmed because the symptoms would subside with the continuation of the intervention In this testing each maneuver is done in a passive way For each measurement it was noted whether vertigo is elicited M or M- Intensity and duration of vertigo will be recorded When nystagmus is observed its presence or absence is noted Ny or Ny- In case of exacerbation of symptoms the exercises will be modified by decreasing the repetition or stopping the exercises until the symptoms disappeared The frequency and duration of the exercises will be customized according the patients response to the exercises In this study the patients were asked to repeat the exercises 5 -10 times for 5 to 10 min for 2 days in a week for 4 weeks The exercises program were be graded so that the patient progresses from easily tolerated movements to difficult ones Gaze stability exercises and balance training The exercises were progressed from sitting to standing and support surface conditions were systematically varied progressing from firm surface to compliant and regular surfaces The exercises were performed in 3 sets or 5 repetitions for 2 days in a week for 4 weeks Data collection In this study 30 subjects who fulfilled the inclusion criteria were included Those meeting the criteria met with the physiotherapist who explained the project Subjects were provided with the general guidance and information about the project and given time to consider involvement The subjects will be given further opportunity to ask questions and then they will give a consent form
After giving consent patients were assessed with Dix- hallpike Vertigo Symptom Scale -sf Berg Balance Scale before the intervention and the findings will be recorded The patients will be divided into 2 groups Group A N 15 and Group B N15 All the outcome were again recoded after the 4 weeks of intervention
Data analysis Data was summarized as Mean SE standard error of the mean Pre and post groups were compared by paired t test Pre to post change pre-post or post-pre in outcome measures of two independent groups will be compared by independent Students t test Discrete categorical data were summarized in number n and percentage and compared by chi-square χ2 test A two-tailed α2 p005 will be considered statistically significant Analyses was performed on SPSS software Windows version 170
Methods Thirty subjects were recruited for the proposed study on the basis of inclusion and exclusion criteria Patients who are diagnosed with posterior canal BPPV by ENT physician and diabetes by the physician through laboratory investigations both male and female aged between 20 to 70 years Positive Dix -Hallpike test Nystagmus lasting less than 60 seconds willing to participate in the study and with a minimum score of 2556 in Berg Balance Scale were included Whereas patients taking antivertigo drugs who had been treated for similar vertigo experience disease of different origin that may cause vertigo like migraine multiple sclerosis stroke traumatic brain injury if CRP has been done before other causes of peripheral vertigo such as Menieres disease vestibular neuritis labrynthitis and perilymphatic fistula pathologies contraindicated for Dix- hallpike maneuver like prolapse intervertebral disk cervical spine instability cervical myelopathy previous cervical spine surgery were excluded Those meeting the criteria will be randomized into Group A ie Epley-Canalith Repositioning and Group B ie Vestibular Rehabilitation Therapy through lottery method
Interventions In Group A control group the affected posterior canal it is the posterior semi-circular canal of the under most ear when the classic nystagmus is provoked was predetermined by Dix-Hallpike test The time of latency and duration of induced nystagmus was recorded by an assistant using stopwatch This provided an estimate of the time required for the canalith bolus trough 90
Procedure will be explained to the patients before the intervention The patients will be asked to keep the eyes open to watch the nystagmus The patient will be seated length wise on the examination table in search a way that when brought to the Hallpike position the head should extend beyond the end of the table An assistant was asked to stand by the side of affected canal
Step 1 The patient was brought down with the head turned 45 towards the affected canal as in Hallpike test The neck was extended
Step 2 The head was rotated 90 towards the unaffected side The neck will be extended Step 3 The head and body was rotated by further 90 from the previous positions now face down The neck was in neutral position Step 4 The patient was brought up in siting position while the head was kept turning towards the unaffected side Step 5 The head was turned forward and the chin will be kept 20 down for a minute
Since all the patients were having nystagmus lasting for less than 60 seconds each position was maintained for 60 second The procedure will be repeated until no nystagmus will be observed during the last cycle or until no progress is apparent in the last two cycles
The intervention will be given for approximately 15min for 2 times in a week for 4 weeks
Before going home all the patients were given instructions
The patients were asked to wait for 10 minutes after the maneuver is performed before going home
Patients were instructed not to lie supine to keep their head at 45 reclining positions while sleeping for 2 days
All patients were asked to avoid provoking head positions like bending over looking up or down for 7 days following the procedure
Group B received Vestibular Rehabilitation Therapy which consisted of habituation exercises gaze stability and balance training Habituation exercises The patient were instructed to sit on the side the examining couch Then he was warned that the exercises could worsen the frequency and intensity of vertigo in the beginning but that they should not alarmed because the symptoms would subside with the continuation of the intervention In this testing each maneuver is done in a passive way For each measurement it was noted whether vertigo is elicited M or M- Intensity and duration of vertigo will be recorded When nystagmus is observed its presence or absence is noted Ny or Ny- In case of exacerbation of symptoms the exercises will be modified by decreasing the repetition or stopping the exercises until the symptoms disappeared The frequency and duration of the exercises will be customized according the patients response to the exercises In this study the patients were asked to repeat the exercises 5 -10 times for 5 to 10 min for 2 days in a week for 4 weeks The exercises program were be graded so that the patient progresses from easily tolerated movements to difficult ones Gaze stability exercises and balance training The exercises were progressed from sitting to standing and support surface conditions were systematically varied progressing from firm surface to compliant and regular surfaces The exercises were performed in 3 sets or 5 repetitions for 2 days in a week for 4 weeks Data collection In this study 30 subjects who fulfilled the inclusion criteria were included Those meeting the criteria met with the physiotherapist who explained the project Subjects were provided with the general guidance and information about the project and given time to consider involvement The subjects will be given further opportunity to ask questions and then they will give a consent form
After giving consent patients were assessed with Dix- hallpike Vertigo Symptom Scale -sf Berg Balance Scale before the intervention and the findings will be recorded The patients will be divided into 2 groups Group A N 15 and Group B N15 All the outcome were again recoded after the 4 weeks of intervention
Data analysis Data was summarized as Mean SE standard error of the mean Pre and post groups were compared by paired t test Pre to post change pre-post or post-pre in outcome measures of two independent groups will be compared by independent Students t test Discrete categorical data were summarized in number n and percentage and compared by chi-square χ2 test A two-tailed α2 p005 will be considered statistically significant Analyses was performed on SPSS software Windows version 170
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None