Comparison of the effect of balance training and a combined of balance, strength, core stability training on static and dynamic balance (mobility) in patients with mild Multiple Sclerosis
Effect of balance training program and effect of combined balance, strength, core stability training program on static and dynamic balance (mobility) in patients with mild Multiple Sclerosis.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 20 patients. The patients were placed in one of two groups A or B using a block randomization method with a quadruple size and using a sealed envelope.
Settings and conduct
After obtaining informed written consent, the participants in Sina Hospital who have met the study inclusion criteria are randomly assigned to one of two intervention and control groups. The patient's outcomes are evaluated and recorded individually at baseline by a skilled assistant using tests and questionnaire. The intervention consists of 8 weeks of home-based exercise trainings that are taught individually to the patients by another assistant. The patients are followed up by the researcher every 2 weeks and complete the exercises logbook. At the end of eight weeks outcomes evaluation is done by the relevant assistant.
Participants/Inclusion and exclusion criteria
Women aged 20 to 45 with Secondary Progressive or Relapsing Remitting Multiple Sclerosis with mild severity, presence of balance disorder and absence of diseases which limiting sports activities are included in the study; If they are unable to complete the study or participate in the sports program at the same time, they will be excluded from the study.
Intervention groups
Intervention group: Eight weeks of balance, strength, core stability exercises (at home), Control group: Eight weeks of balance exercises (at home).
Main outcome variables
Static balance is evaluated using Berg Balance Scale. Dynamic balance (mobility) is evaluated using the 10 meter walking test and Timed Up and Go test. Quality Of Life is evaluated with the Short Form 36 Questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240119060728N1
Registration date:2024-03-18, 1402/12/28
Registration timing:prospective
Last update:2024-03-18, 1402/12/28
Update count:0
Registration date
2024-03-18, 1402/12/28
Registrant information
Name
Maryam Eghtesadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 5270
Email address
m_eghtesadi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of balance training and a combined of balance, strength, core stability training on static and dynamic balance (mobility) in patients with mild Multiple Sclerosis
Public title
Effect of Balance, strength, core stability training on balance impairment in patients with mild Multiple Sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 25-40 years
Female gender
Suffering from Relapsing Remitting or Secondary Progressive Multiple Sclerosis based on McDonald Criteria and according to the neurologist's diagnosis
EDSS less than 4 (The person can walk more than 100 meters without help and independently)
The patient is being treated with common MS drugs
Complaints of balance disorder
Absence of other neurological diseases that lead to balance impairments
Not suffering from psychiatric diseases
Absence of orthopedic disorders and diseases that prevent exercises
Absence of cardiovascular and pulmonary diseases and disorders
Any other disorder or disease that prevents a person from doing exercises
Do not taking psychiatric drugs
No relapse in the last month
Not participating in a regular exercise program in the last 4 weeks
No treatment with corticosteroids (injection or oral) during the last 2 weeks
Exclusion criteria:
Participate in the sports program at the same time
Inability to complete exercises
Age
From 25 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to one of the two groups A or B using the block randomization method with a block size of four and using a sealed envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
All stages of the study for two control and intervention groups are done using a double blind design in separate sessions, namely each group does not know the type of exercises of the other group. The evaluation of patient's outcomes before and after the intervention are done by an expert assistant other than researchers themselves, who have no knowledge of the type of exercises of that person, which are done. Education of exercises is done by another specialist assistant. Data analysis is carried out by the researcher.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research of Sina Hospital, Tehran University of Medical Sciences
Street address
Sina Hospital., Hassan Abad Square., Imam Khomeini Street
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2023-05-24, 1402/03/03
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1402.028
Health conditions studied
1
Description of health condition studied
Balance impairment in patients with Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Berg Balance Scale
Timepoint
Baseline (before the start of the intervention), eight weeks later (at the end of the intervention)
Method of measurement
The sum of functional scales obtained by the patient in numbers
2
Description
10 meters walk test
Timepoint
Baseline (before the start of the intervention), eight weeks later (at the end of the intervention)
Method of measurement
Walking time of the 6-meter distance with a stopwatch in seconds
3
Description
Timed Up and Go test
Timepoint
Baseline (before the start of the intervention), eight weeks later (at the end of the intervention)
Method of measurement
Time of going back and forth at a distance of three meters with stopwatch in seconds
Secondary outcomes
1
Description
Quality of life
Timepoint
Before starting the intervention at baseline and eight weeks later at the end of the intervention
Method of measurement
The total points obtained from the Short Form 36 Questionnaire
Intervention groups
1
Description
Intervention group: The desired and intended intervention includes 8 weeks of home based exercises. These exercises in the intervention group include balance, strength, core stability exercises. The exercises include lower limb strength, core stability exercises 3 days a week and with 24 to 48 hours of recovery between strength, core stability training sessions and also performing balance exercises on empty days between Strength, core stability sessions (a total of 7 days per week of training, 3 days of strength, core stability training and 4 days of balance training).
Category
Treatment - Other
2
Description
Control group: Exercises in this group include eight weeks of home based exercise training, which includes performing balance exercises 7 days a week.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Maryam Eghtesadi
Street address
Sina Hospital., Hassan Abad Square., Imam Khomeini Street
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
hosp_sina@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
6th floor of Research and Technology Vice Chancellor., Central Organization of the University., Corner of Quds St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
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
Maryam Eghtesadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department., 1st floor., Mahdi Clinic Hospital., Imam Khomeini Hospital Complex., Down the Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 5270
Email
m_eghtesadi@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Eghtesadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department., 1st floor., Mahdi Clinic Hospital., Imam Khomeini Hospital Complex., Down the Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 5270
Fax
+98 21 8895 3003
Email
m_eghtesadi@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Eghtesadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department., 1st floor., Mahdi Clinic Hospital., Imam Khomeini Hospital Complex., Down the Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 5270
Fax
Email
m_eghtesadi@razi.tums.ac.ir
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The current research has been registered as a proposal for the thesis of the sports medicine residency. The thesis resulting from this proposal including participant datas, study protocol, statistical analysis and study report (including all variables) will be provided to Tehran University of Medical Sciences and Sports Medicine Education Department. It should be noted that after the approval of the thesis, an article containing all the mentioned items will be published in one of the journals that are relevant to the research topic. The data of the participants, the study protocol and the study report (all variables) in the form of a thesis of specialist assistance and after the approval of the thesis, it will be published as an article.
When the data will become available and for how long
The beginning of writing the proposal of the present study has been started from October 23, 2022, and two years have been predicted for all the stages until it was submitted in the form of a thesis. The data obtained from this research will be presented in the form of an article after the approval of the thesis (at the end of two years).
To whom data/document is available
The data obtained from this research will be available to the research authors, supervisors and research advisors, Tehran university of medical sciences and sports medicine training department of Tehran University of Medical Sciences. It will be published in a reputable journal and will be made available to readers according to the rules of that journal.
Under which criteria data/document could be used
There are no restrictions on the use, publication and processing of the data of this study, provided that the correspondence is done by email with the corresponding author of the study and the necessary permission is issued by the corresponding author.
From where data/document is obtainable
The applicant must communicate with the corresponding author of this study through e-mail.
What processes are involved for a request to access data/document
The permission to use the information is issued to the applicant after receiving and viewing the email as soon as possible, and then the requested information is sent to the applicant's email.