The effect of dynamic neuromuscular stabilization exercises on balance and balance confidence in patients with multiple sclerosis
Design
The study is a clinical trial with a control group, with parallel, double-blind and randomized groups.
Settings and conduct
After obtaining an ethics license from the Medical Ethics Committee of Isfahan University of Medical Sciences and also registering the study protocol in the Iranian clinical trial registration system, patients with multiple sclerosis are invited to this study by a neurologist based in Ayatollah Kashani Hospital. The intervention is performed in the physiotherapy ward of Kashani Hospital.
Participants/Inclusion and exclusion criteria
Patients (male or female) with multiple sclerosis with EDSS zero to 5.5 who are not in the acute phase of their disease.
Intervention groups
The control group performs only conventional treatment according to sources and the intervention group performs dynamic neuromuscular stabilization exercises.
Main outcome variables
Balance and Balance Confidence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200101045970N7
Registration date:2023-01-01, 1401/10/11
Registration timing:registered_while_recruiting
Last update:2023-01-01, 1401/10/11
Update count:0
Registration date
2023-01-01, 1401/10/11
Registrant information
Name
Ehsan Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 3089
Email address
eghasemi@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Dynamic Neuromuscular Stabilization on Balance and Balance Confidence in patients with Multiple Sclerosis.
Public title
The effect of stabilizing exercises on MS patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least one year has passed since the diagnosis
Age range 15 to 55 years and being in the disease remission period
Having a mild to moderate degree of disability (EDSS = 0-5.5) as determined by your doctor.
No recurrence of the disease during the last month
No other diseases such as cardiovascular, osteoarthritis, respiratory, skin, cognitive disorders, diabetes and cancer
Stability of the patient's vital signs
Being able to walk without an aid
Exclusion criteria:
Lack of regular participation in training sessions
Recurrence of the disease during the project
Having certain illnesses, such as heart disease, or problems such as fatigue, so that continuing to exercise is detrimental to her.
Use of pharmacological agents to control fatigue
Depressive and sleep disorders that lead to fatigue.
Participate in an exercise program 8 weeks in past and during treatment
Serious balance problems that put a person at risk of falling.
Age
From 15 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients are randomly divided into one of two experimental and control groups after examining the inclusion and exclusion criteria. In this study, due to the small number of samples, in consultation with a statistician, it was decided to use the random blocking method. Blocking is usually used to balance the number of samples assigned to each of the groups studied. The statistician used the website https://www.sealedenvelope.com/simple-randomiser/v1/lists, Considering that we had 2 groups, they designed 20 two-person blocks. . A person who divides patients into two groups based on this table is unaware of the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, because sufficient information about the exercises is given to the participants and it is explained to each of them that they may be randomly placed in one of the two groups, so the participants are not blind. In this study, the evaluator of balance and confidence in balance does not know which group the participant is in, so our evaluator is blind. In addition, the person analyzing the data does not know which person is in which group and only compares the data between the two groups, so they are also blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-11-08, 1401/08/17
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.100
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
Balance
Timepoint
Before the start of treatment, after the end of treatment and 2 months after the end of the last treatment session
Method of measurement
Use of Mini BES Test
2
Description
Balance Confidence
Timepoint
Before the start of treatment, after the end of treatment and 2 months after the end of the last treatment session
Method of measurement
Use of ABC Scale
Secondary outcomes
1
Description
Assessment of functional mobility
Timepoint
Before the start of treatment, after treatment and 2 months after the end of the last treatment session
Method of measurement
Use of TUG test
Intervention groups
1
Description
Intervention group: Receive dynamic neuromuscular stabilization exercises. These exercises are performed in different positions that are actually modeled on the positions of the growing baby. Exercises start with simple situations and gradually become more complex. In fact, the exercises start with the supine and then progress to the rolling, sitting, bear and squat-like postures. In each training session, 3 different situations are taught. Each exercise is maintained 3 times for 10 seconds and the patient is given 10 seconds of rest between each. Patients are treated for 4 weeks with a regimen of 3 sessions per week, every other day. The duration of each treatment session is 30 minutes.
Category
Rehabilitation
2
Description
Control group: Routine balance exercises that include both movement and sensory strategies. Movement strategy includes stabilizing exercises, dual exercises, and ankle balance strategy. Double exercises are generally changed from static to dynamic and walking to make them more advanced. Sensory strategy also tries to strengthen vestibular and sensory-physical information by reducing visual input. Therefore, to achieve this goal, we do some movement phase exercises with closed eyes. Patients are treated for 4 weeks with a regimen of 3 sessions per week, every other day. The duration of each treatment session is 30 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
kashani Hospital
Full name of responsible person
Ehsan Ghasemi
Street address
Street of Ayatollah Kashani
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
kashani@mui.ac.ir
Web page address
https://kashani.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Vice Chancellor for Research and Technology, Building No. 4, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Ehsan Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3669 3089
Email
eghasemi@rehab.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ehsan Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences,Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3669 3089
Email
eghasemi@rehab.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ehsan Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation Sciences,Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3669 3089
Email
eghasemi@rehab.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because of confidentiality
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
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
Study protocol, informed consent form and clinical study report
When the data will become available and for how long
The study protocol and consent form are now available in the proposal. The clinical study report will be published after the work is completed.
To whom data/document is available
All researchers working in scientific institutes can access the proposal.
Under which criteria data/document could be used
To be aware of the study conditions and get acquainted with scientific concepts.
From where data/document is obtainable
Contact Dr. Ehsan Ghasemi via email or mobile.
What processes are involved for a request to access data/document
Immediately after sending the email and receiving the request.