Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05828433 |
| Other study ID # |
04/JUREC/15PT.2022 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 7, 2022 |
| Est. completion date |
January 17, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
University of Jazan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
Description:
Research Objectives:To 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 25/56 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 Meniere's 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 i.e.,
Epley-Canalith Repositioning and Group B i.e., 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 9°0 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 patient's 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 (N=15). 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 Student's t test. Discrete
(categorical) data were summarized in number (n) and percentage (%) and compared by
chi-square (χ2) test. A two-tailed (α=2) p<0.05 will be considered statistically significant.
Analyses was performed on SPSS software (Windows version 17.0).
