The evaluation of the additive value of performing cognitive task while inducing whole body vibration on balance indices and cognition in multiple sclerosis patients
The evaluation of the additive value of performing cognitive task while inducing whole body vibration on balance indices and cognition in multiple sclerosis patients
Design
This study is a randomized controlled clinical trial with parallel, single blind, randomized block design with Block Randomization. The sample size is 20 patients in each group.
Settings and conduct
This study will be conducted in Shiraz School of Rehabilitation Sciences and the study population will be randomly divided into control (whole body vibration apparatus) and intervention (whole body vibration apparatus at the same time as performing cognitive task) groups. Assessments will be performed by a physiotherapist who is unaware of how the groups are assigned and treatment by another physiotherapist. Data analyser will also be unaware of group assignments. The sample size will be determined after a study as a pilot, considering that there is no similar study. According to the statistics consultant, 20 patients in each group will be taken as a pilot and then the final sample size will be determined
Participants/Inclusion and exclusion criteria
Patients with relapsing-remitting multiple sclerosis in the age range of 20 to 50 years who are able to ambulate at least 100 meters independently without aids or assistance included. Patients with any other musculoskeletal or neurological conditions that limit balance are excluded.
Intervention groups
Intervention group is treated by whole body vibration apparatus at the same time as performing stroop cognitive task. And control group is treated by only whole body vibration apparatus.
The evaluation of the additive value of performing cognitive task while inducing whole body vibration on balance indices and cognition in multiple sclerosis patients
Public title
The evaluation of the additive value of cognitive task on whole body vibration on balance and cognition in multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 20-50 years
A definite diagnosis of MS, Relapsing-remitting type, as diagnosed by a neurologist
Patients with mild to moderate disability (EDSS = 1-5.5) who are able to stand or ambulate independently. (ambulate at least 100 meters independently without aids or assistance)
Literacy
Fluent and understandable speech
Exclusion criteria:
Pregnancy
A positive history of having fracture and implant in the knee and hip joints
History of epilepsy
Malignant tumors
Corticosteroid injection 28 days before the intervention
Severe osteoporosis
Discopathy, Acute protrusion, Spondylolisthesis
Severe diabetes
Severe wounds and scarring
Any musculoskeletal or neurological conditions except MS limiting balance
Uncorrected auditory or visual impairment
Disorders of the vestibular system at the diagnosis of a specialist
Severe mental disorders that lead to impossibility of cooperation of the participant.
Using drugs which affecting balance
Vertigo
History of attacks and relapses during the past 2 months
Having experience of vibration during the last 3 months
Receive physiotherapy interventions simultaneously or up to 1 month before the start of the research project
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to each group by applying Random Allocation software, in a blocking method (size of 4). Group allocation will be defined in a block of four (2 participants in each group) and continue to put all 40 participants into two groups of Intervention and control.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyser and the physiotherapist who will measure the outcome measures, will be blinded to the patient’s allocation group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Rehabilitation School of Shiraz University of Medical Sciences, Abiverdi 1 St., Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
33669-71947
Approval date
2020-05-20, 1399/02/31
Ethics committee reference number
IR.SUMS.REHAB.REC.1399.018
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Static balance
Timepoint
Before and after intervention
Method of measurement
Biodex balance system
2
Description
Dynamic balance
Timepoint
Before and after intervention
Method of measurement
Biodex balance system
3
Description
Functional balance
Timepoint
Before and after intervention
Method of measurement
Mini Balance Evaluation Systems Test (Mini- BESTest)
4
Description
Balance confidence
Timepoint
Before and after intervention
Method of measurement
Activities Specific Balance Confidence scale (ABC)
5
Description
Risk of falling
Timepoint
Before and after intervention
Method of measurement
Biodex balance system
6
Description
Cognitive performance
Timepoint
Before and after intervention
Method of measurement
Montreal Cognitive Assessment Test (MOCA), Symbol Digit Modalities Test (SDMT)
Secondary outcomes
1
Description
Quality of life
Timepoint
Before and after intervention
Method of measurement
Multiple Sclerosis Quality of Life-54 Questionnaire (MSQoL-54)
Intervention groups
1
Description
Intervention group: Patients are treated for 6 weeks, 3 sessions per week, 5 set per session by whole body vibration apparatus at the same time as performing Stroop cognitive task. In this task, congruent and incongruent colored words will be shown to the patients randomly in each trial. In the congruent condition the word and its color are the same and in the incongruent condition the word and its color will be different. For example, the word "blue" will be displayed in a different color; for example, with yellow color letters. Vibration rate in the first 2 weeks 5 set of 30 seconds with 1 minute break between sets, in the second 2 weeks 5 set of 45 seconds with 1 minute break between sets and in the third 2 weeks 5 set of 1 minute with 1 minute break is between sets.
Category
Rehabilitation
2
Description
Control group: This group is treated by only whole body vibration apparatus. Vibration rate is as the same as intervention group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation Clinic of Shiraz School of Rehabilitation Sciences
Full name of responsible person
Dr. Mohsen Razeghi
Street address
Rehabilitation School of Shiraz University of Medical Sciences, Abiverdi 1 St., Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1551
Email
razeghm@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Abbas Rezaianzadeh
Street address
Building of Shiraz University of Medical Sciences, Zand St., Shiraz.
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
rezaiana@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahsa Badpa
Position
MSc Student of Physical Therapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation School of Shiraz University of Medical Sciences, Abiverdi 1 St., Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1551
Email
m_badpa@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohsen Razeghi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation School of Shiraz University of Medical Sciences, Abiverdi 1 St., Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1551
Email
razeghm@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahsa Badpa
Position
MSc Student of Physical Therapy
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation School of Shiraz University of Medical Sciences, Abiverdi 1 St., Chamran Blvd.
City
Shiraz
Province
Fars
Postal code
33669-71947
Phone
+98 71 3627 1551
Email
m_badpa@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available