The aim of this study is to evaluate the effectiveness of Whole Body Vibration on Strength and Endurance of Core muscles in Ambulant Patients with Multiple Sclerosis (MS). Patients with MS who experiences the last two months of relapse and does not have attack and aged between 20 and 50 years are enrolled. Patients with corticosteroids injection at least 28 days before the intervention are excluded.The sample size for this pilot study is 25 patients in each group. Patients are randomly divided into two groups. Intervention group are treated with Whole Body Vibration for 6 weeks, 3 times a week. The control group will not receive any treatment. Strength is measured using a dynamometer and endurance is evaluated with endurance tests before and after the intervention. A month after the intervention quality of life questionnaire will be assessed again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041328447N6
Registration date:2017-06-19, 1396/03/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-19, 1396/03/29
Registrant information
Name
Amin Kordi Yoosefinejad
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 1081
Email address
yoosefinejad@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
School of Rehabilitation Sciences, Shiraz University of Medical Sciences
Expected recruitment start date
2017-06-05, 1396/03/15
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To Evaluate the Effectiveness of Whole Body Vibration on Strength and Endurance of Core muscles in Ambulant Individuals with Multiple Sclerosis
Public title
To Evaluate the Effectiveness of Whole Body Vibration on Strength and Endurance of Core muscles in Ambulant Individuals with Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: People with mild to moderate disability (EDSS=1-5.5)the ability to ambulate 10 meters with or without assisstive device; Confirmed diagnosis of MS by physician; Lack of mental problems , Fracture and have an implant in the body; No history of attacks and relapses during the past 2 months; Having no experience of vibration during the last 3 months; Age range of 20-50 years
Exclusion criteria: Implant in the body; Epilepsy; Tumors; Corticosteroid injection 28 days before the intervention; Osteoporosis; Discopathy; Diabetes; Severe wounds and scarring; Attacks during the application of WBV
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Science
Street address
Zand Ave, Building of Shiraz University of Medical Science
City
Shiraz
Postal code
713451733
Approval date
2017-01-22, 1395/11/03
Ethics committee reference number
IR.SUMS.REC.1395.167
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
Isometric Strength of Flexor Muscles of Trunk
Timepoint
Before and After Intervention
Method of measurement
Measuring Isometric Strength with Dynamometer a specified period
2
Description
Isometric Strength of Extensor Muscles of Trunk
Timepoint
Before and After Intervention
Method of measurement
Measuring Isometric Strength with Dynamometer a specified period
3
Description
IsometricSstrength of Lat Flexor Muscles of Trunk
Timepoint
Before and After Intervention
Method of measurement
Measuring Isometric Strength with Dynamometer a specified period
4
Description
Endurance of Flexor Muscles of Trunk
Timepoint
Before and After Intervention
Method of measurement
Measuring Isometric Strength with Dynamometer a specified period
5
Description
Endurance of Extensor Muscles of Trunk
Timepoint
Before and After Intervention
Method of measurement
Measuring Isometric Strength with Dynamometer a specified period
6
Description
Endurance of Lat Flexor Muscles of Trunk
Timepoint
Before and After Intervention
Method of measurement
Measuring Isometric Strength with Dynamometer a specified period
Secondary outcomes
1
Description
Quality of Life
Timepoint
One Month After Intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Patients are treated for 6 weeks, 3 sessions per week, 5 sets per session by Whole Body Vibration apparatus.The vibration exercise to rest ratio is 30:60 for the first two weeks(Vibration: 30 seconds and rest: 60 seconds), 45:60 for the third week and fourth weeks and 60:60 for the fifth and sixth weeks.
Category
Rehabilitation
2
Description
Control group: This group does not receive any treatment and continue their normal life
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
MS Society of Shiraz and Neurology Clinics affiliated to Shiraz University of Medical Science
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Science
Full name of responsible person
Dr.Gholamreza Hatam
Street address
Zand Av, Shiraz University of Medical Science
City
Shiraz
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 Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz School of Rehabilitation Science
Full name of responsible person
Maryam Abbasi
Position
Master student
Other areas of specialty/work
Street address
Abiverdi1, chamran Blvd, shiraz, Iran
City
Shiraz
Postal code
713451733
Phone
+98 71 3626 5108
Fax
+98 71 3627 2495
Email
abbasi_pt90@yahoo.com; yoosefinejad@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz School of Rehabilitation Science
Full name of responsible person
Dr. Amin Kordi Yoosefinejad
Position
Ph.D of Physiotherapy
Other areas of specialty/work
Street address
Abiverdi1, chamran Blvd, Shiraz, Iran
City
Shiraz
Postal code
713451733
Phone
+98 71 3626 5108
Fax
+98 71 3627 2495
Email
yoosefinejad@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz School of Rehabilitation Science
Full name of responsible person
Maryam Abbasi
Position
Master student
Other areas of specialty/work
Street address
Abiverdi1, chamran Blvd, shiraz, Iran
City
Shiraz
Postal code
713451733
Phone
+98 71 3626 5108
Fax
Email
abbasi_pt90@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)