Evaluation of the effect of aerobic exercise with stationary bike in concomitant with trans cranial direct current stimulation on gait improvement in multiple sclerosis patients
evaluation the effect of aerobic exercise with stationary bike with trans cranial direct current stimulation on gait improvement in multiple sclerosis patients
Design
Clinical trial with control group, with parallel, double-blind, randomized
Settings and conduct
A study was conducted at the Neurology Research Center of Imam Khomeini Hospital.double-blind (researcher & patients)
Participants/Inclusion and exclusion criteria
inclusion criteria: definite MS, age:18-48, EDSS<6, mild to moderate spasticity or MAS scale grade less than 3 on remission period ; No recurrence of the disease in the last 30 days
exclusion criteria:Dissatisfaction patients to enter the study and follow up ;Active phase of the disease; Pregnant women ;Simultaneous use of neuromuscular electrical stimulation techniques; Underlying illness ;accompanied History of using TDCS
Intervention groups
The room's temperature will be set to 21 degrees for both groups.
control group:
for Twenty-five patients with multiple sclerosis (relapsing remitting type) with EDSS<6 : During the 6 weeks & twice a week( 12 session).In each session for the patient work with stationary bike a total of 30 minutes :10 minutes of activity And 5 minutes of rest with 20 watts per minute It will also use tdcs as the sham.
A case group with similar specifications in addition to the use of a bike Also received tDCS.In the sitting position, two electrodes (anode and cathode) are placed on the desired locations.Anod is placed in the motor cortical area (3C) and the cathode in the shoulder region And will be adjusted at 1.5 mAh intensity and within 20 minutes.
Main outcome variables
initially, 6 weeks and 3 months later;
Muscle weakness by VAS;
Disability rate will be measured later by EDSS ;
Fatigue severity is measured ( FSS);
Quality of life is measured f by Multiple sclerosis quality of life questionnaire MSQOL-54
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180703040321N1
Registration date:2018-10-29, 1397/08/07
Registration timing:registered_while_recruiting
Last update:2018-10-29, 1397/08/07
Update count:0
Registration date
2018-10-29, 1397/08/07
Registrant information
Name
mohaddeseh Azadvari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2291
Email address
m-azadvari@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of aerobic exercise with stationary bike in concomitant with trans cranial direct current stimulation on gait improvement in multiple sclerosis patients
Public title
Evaluation the effect of aerobic exercise with stationary bike with trans cranial direct current stimulation on gait improvement in multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
definite MS according to Mc Donald criteria
age:18-48,
EDSS<6,
mild to moderate lower limbs spasticity ,MAS scale<3
on remission period
No recurrence of the disease in the last 30 days
Exclusion criteria:
Dissatisfaction patients to enter the study and follow up
Active phase of the disease
Pregnant women
Simultaneous use of neuromuscular electrical stimulation techniques
Underlying illness accompanied
History of using TDCS
Age
From 18 years old to 48 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Based on the quadruple number block
Blinding (investigator's opinion)
Double blinded
Blinding description
After the patients entered the study according to entry and exit criteria,Initial evaluation carried out by a researcher fellow,They will then be packed with a fellow secretary in a random Which identifies the line and day of treatment Which is done by another research colleague.After the completion of the treatment, the assessment will be carried out by a colleague of another researcher
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical science
Muscle force/Quality of life/severity of disability/severity of fatigue
Timepoint
before intervention and after 6weeks
Method of measurement
Muscle force:manual muscle test/ MS Quality of life questionnaire/ severity of disability:Expanded disability status scale/ severity of fatigue:Fatigue severity scale questionnaire
Intervention groups
1
Description
Intervention group: The patients received transcranial direct current stimulation with 1/5 mA and during 20 minutes and at the same time they are cycling with stationary bike during 30 minutes with 5 minutes rest between every 10 minutes
Category
Rehabilitation
2
Description
Control group: The patients are cycling with stationary bike during 30 minutes and 5 minutes rest between every 10 minutes and used transcranial direct current stimulation as sham
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
Mohaddeseh azadvari
Street address
Keshavarz BLV
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Fax
+98 21 6658 1615
Email
m-azadvari@tums.ac.ir
Web page address
http://ikhc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr mohammad ali sahraian
Street address
Tehran University of Medical Sciences Office of Vice-Chancellor for Global Strategies and International Affairs, Number 21, Dameshgh St., Vali-e Asr Ave., Tehran 1416753955
City
tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8889 6692
Email
drazadvari@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
mohadeseh azadvari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
End of Keshavarz Blvd,Tehran
City
Tehran
Province
Tehran
Postal code
1418733141
Phone
+98 21 61190
Email
drazadvari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
mohadeseh azadvari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
End of keshavarz Blvd.Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21611190
Email
drazadvari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohadeseh azadvari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
End of keshavarz Blvd.Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 61190
Email
drazadvari@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Results of data analysis after the article published
If required, raw data will be provided by the researcher in correspondence with the responsible author.
When the data will become available and for how long
the article will be accessible 2 months after its publication date
To whom data/document is available
all people working in academic institutions or people working in businesses
Under which criteria data/document could be used
Those who request information regarding our research should submit their request via their university vice-chancellor or official authority of their academic institution
From where data/document is obtainable
via E-mail: drazadvari@yahoo.com
contact number: +982161192291
What processes are involved for a request to access data/document
the requester should provide more details on the processes involved to receive these documents /data files. the description should give sufficient insight to the applicant of the amount of time needed to follow through these processes.