Evaluation and comparison of gait pattern of patients with multiple sclerosis before and after an aerobic exercise course by fixed bicycle plus direct brain stimulation (tDCS)
Evaluation and comparison of gait pattern of patients with multiple sclerosis before and after an aerobic exercise course by fixed bicycle plus direct brain stimulation (tDCS)
Design
Ten patients with multiple sclerosis with Expanded Disability Status Scale (EDSS) score of less than 6 were included in the study. Initially demographic information and quality of life questionnaire will be filled for them. Gait analysis is then performed for them, after that the patient undergoes 12 sessions of fixed-bike exercise and brain stimulation, and again the questionnaires are filled and re-analyzed.
Settings and conduct
Imam khomeini hospital, Tehran university of medical science.
Participants/Inclusion and exclusion criteria
Inclusion criteria:the patients with multiple sclerosis; with mild to moderate involvement; with Expanded Disability Status Scale (EDSS)<6,
Exclusion criteria: history of convulsion and major disease ;History of other major disease;history of head trauma
Intervention groups
12 session exercise with fixed bicycle with brain stimulation(TDCS), 2 times in week, 6 week
Evaluation and comparison of gait pattern of patients with multiple sclerosis before and after an aerobic exercise course by fixed bicycle plus direct brain stimulation (tDCS)
Public title
Evaluation of exercise plus brain stimulation on gait of patients with multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
multiple sclerosis patient
mild to moderate involvement, EDSS< 6
Exclusion criteria:
history of convulsion
hisory of other major disease such as stroke and ...
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Imam Khomeini Hospital Complex- Tehran University of Medical Sciences
Street address
Imam Khomeini hospital, at the end of Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2020-01-04, 1398/10/14
Ethics committee reference number
IR.TUMS.IKHC.REC.1398.241
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
gait velocity
Timepoint
Before and after intervention
Method of measurement
according gait analysis results
2
Description
steps number
Timepoint
Before and after intervention
Method of measurement
According gait analysis results
3
Description
Cadance number
Timepoint
Before and after intervention
Method of measurement
According gait analysis results
4
Description
Step length
Timepoint
Before and after intervention
Method of measurement
According gait analysis results
5
Description
cadance Length
Timepoint
Before and after intervention
Method of measurement
According gait analysis results
6
Description
gait angels
Timepoint
Before and after intervention
Method of measurement
According gait analysis results
Secondary outcomes
1
Description
evaluation of quality of life
Timepoint
befor and after intervention
Method of measurement
MSQL-54 questionare
Intervention groups
1
Description
Intervention group: multiple sclerosis patients, at first we analysis gait of the patients, after that the patients will doing exercsie with TDCS for 12 session, after that we will analysis the patients gait again and will compare before and after gait analysis results.