The effect of vestibular rehabilitation program on the balance performance of people with multiple sclerosis
Design
Clinical trials with control group, with parallel groups,one blind, randomized
MS patients who have entered the study are divided into 3 groups using a randomized six-point blocking; receiving vestibular rehabilitation therapy (group A), receiving galvanic vestibular stimulation (group B) and without receiving any vestibular rehabilitation (group C).
The sample size was 21 people. According to the probability of falling, 3 groups of 8 people were selected.
Settings and conduct
select individuals to enter the study
Pre-interventional studies in all subjects
Provide rehabilitation intervention for 6 weeks, 2 sessions per week and 30 minutes each session
Post-interventional studies at the end of week 1 to 6 (6 times) in the subjects of the three study groups
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Definitive diagnosis of recurrent recurrent MS (RRMS)
Individual complaint of dizziness or imbalance
Ability to stand without assistance for at least 1 minute
Exit criteria:
Changing the patient's condition
Absence of abnormalities in any of the vestibular function tests
Intervention groups
Group one; vestibular rehabilitation therapy
Group two; galvanic vestibular rehabilitation
Group three; with no rehabilitation
The effect of vestibular rehabilitation program on the balance performance of people with multiple sclerosis
Public title
The effect of vestibular rehabilitation in multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
with Multiple sclerosis
Complaint with dizziness or imbalance
Ability to stand for at least one minute
Exclusion criteria:
Changing the patient's condition (MS recurrence stage)
Absence of abnormalities in any of the vestibular functin tests
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Six random blocking
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher who performs rehabilitation is unaware of the results of rehabilitation until the completion of the study.
An outcome evaluator evaluating post-rehabilitation outcomes is unaware of the type of rehabilitation received for the subjects being studied.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of university of social welfare and rehabilitation sciences
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Approval date
2018-05-29, 1397/03/08
Ethics committee reference number
IR.USWR .REC.1397.004
Health conditions studied
1
Description of health condition studied
Vestibular disorders
ICD-10 code
H81
ICD-10 code description
Disorders of vestibular function
2
Description of health condition studied
multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
composite score in posturography test
Timepoint
At the beginning of the study (before the intervention), weeks 1 to 6 after intervention, and one month After the end of the intervention
Method of measurement
by means of recording device of posturography
2
Description
dizziness handicap inventory score
Timepoint
At the beginning of the study (before the intervention), weeks 1 to 6 after intervention, and one month After the end of the intervention
At the beginning of the study (before the intervention), weeks 1 to 6 after intervention, and one month After the end of the intervention
Method of measurement
by means of questionnaire completion
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group:The first intervention group receive vestibular rehabilitation theraphy (VRT), the second intervention group receive galvanic vestibular stimulation (GVS).
Category
Rehabilitation
2
Description
Control group: Do not receive any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Multiple sclerosis society, Rofeydeh hospital
Full name of responsible person
Ali Najafi (Multiple sclerosis society), Azam Moeini (Rofeydeh hospital)