Eight weeks of DNS training has an effect on the stability of posture and walking time of multiple sclerosis patients
Design
In this study, 40 patients with multiple sclerosis who meet the conditions for entering the study are selected. Participants are randomly divided into intervention and control groups.
Settings and conduct
The pre-test and post-test are conducted in the sports science laboratory of Shahid Beheshti University. Location of Tehran
Participants/Inclusion and exclusion criteria
Relapsing-remitting type of MS in the participants of the present study, The duration of the disease is 10 to 15 years, Age range 40 to 55, The degree of disability is 4 to 5.5 on the EDSS scale, Criteria for non-entry: Older and younger ages Unwillingness to participate in research
Intervention groups
8 weeks of DNS exercises
Main outcome variables
Dynamic balance, postural stability, walking time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240306061185N3
Registration date:2024-03-19, 1402/12/29
Registration timing:prospective
Last update:2024-03-19, 1402/12/29
Update count:0
Registration date
2024-03-19, 1402/12/29
Registrant information
Name
Hossein Rezaei
Name of organization / entity
The University of Shahid Beheshti
Country
Iran (Islamic Republic of)
Phone
+98 24 3562 3177
Email address
hosse.rezaei@mail.sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-24, 1403/01/05
Expected recruitment end date
2024-03-29, 1403/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Eight Weeks Dynamic Neuromuscular Stabilization (DNS) Training on Posture Stabilization and Walk Time in Patients with Multiple Sclerosis
Public title
Dynamic Neuromuscular Stabilization (DNS) Training
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The type of MS in the participants of the present study is relapsing-remitting
The duration of the disease is 10 to 15 years
Age range from 40 to 55 years
The degree of disability is 4 to 5.5 on the EDSS scale
Exclusion criteria:
Age
From 40 years old to 55 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method, unit: individually, randomization tool: to determine the grouping of people in the research by simple randomization method, first a list of people's names is prepared in Excel software. Then we select a random number for each person using the RAND function and finally group the people using the MOD ROW function.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sport Sciences Research Institute
Street address
Mir Emad Ave., Tehran
City
Tehran
Province
Tehran
Postal code
141173116
Approval date
2023-08-22, 1402/05/31
Ethics committee reference number
IR.SSRC.REC.1402.099
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Walking time in multiple sclerosis patients
Timepoint
Before the intervention and eight weeks later
Method of measurement
Berg Balance Test (BBT) and 10-meter walk test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The DNS protocol will be performed on the intervention group in eight weeks, 3 times a week under the supervision of the examiner .Berg's 14-step test is used to measure balance. Berg's balance Scale or BBS is a clinical test to check static and dynamic balance, especially in neurological patients. This test takes about 15 to 20 minutes. The minimum score of each test is 0 and the maximum score is 4. Finally, the sum of all steps is considered as the total score. If the sum of acquired points of the patient is less than or equal to 20, the patient will need a wheelchair. If the sum of the patient's points is greater than 20 and less than or equal to 40, the patient will need help in walking. Patients whose score is more than 40 can walk independently. The maximum score of the paper test is 56
Category
Rehabilitation
2
Description
Control group: We ask the control group not to do any activities that affect the research process, including sports
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sports Science Laboratory of Shahid Beheshti University
Full name of responsible person
Sirus Shaikhi
Street address
Shahid Beheshti University, Shahriari square, Volanjek Town, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 1953
Email
hosse.rezaei@mail.sbu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Seyed Mohammad Hosseini
Street address
Shahid Beheshti University, Shahriari square, Volanjek Town, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 1953
Email
Moh_hosseini@sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Shahid Beheshti
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
The University of Shahid Beheshti
Full name of responsible person
Hossein Rezaei
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Sports Injury and corrective exercises
Street address
No 403., Nawab Safavi Ave., Imam Hossein Square., Sain Qala
City
Sain Qala
Province
Zanjan
Postal code
4574148543
Phone
+98 24 3562 3177
Email
hosse.rezaei@mail.sbu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Hossein Rezaei
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Sports Injury and corrective exercises
Street address
No 403., Nawab Safavi Ave., Imam Hossein Square., Sain Qala
City
Sain Qala
Province
Zanjan
Postal code
4574148543
Phone
+98 24 3562 3177
Email
hosse.rezaei@mail.sbu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Hossein Rezaei
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Sports Injury and corrective exercises
Street address
No 403., Nawab Safavi Ave., Imam Hossein Square., Sain Qala
City
Sain Qala
Province
Zanjan
Postal code
4574148453
Phone
+98 24 3562 3177
Email
hosse.rezaei@mail.sbu.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