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The effect of dynamic neuromuscular stabilization exercises in comparison to core stability exercises on balance, falling and spasticity in people with multiple sclerosis: a double blind randomized control trial

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History
# Registration date Revision Id
4 2021-11-15, 1400/08/24 205899
3 2021-08-30, 1400/06/08 195928
2 2021-01-10, 1399/10/21 166837
1 2020-04-07, 1399/01/19 128382
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  • Protocol summary

    The intervention is performed in the School of Rehabilitation Sciences of Iran University of Medical Sciences. In this study, both the participants and the assessor are blind.
    The intervention is performed in the patient's house because of COVID-19 pandemic. In this study, both the participants and the assessor are blind.
    مداخله در دانشکده ی علوم توانبخشی دانشگاه علوم پزشکی ایران انجام می شود. در این مطالعه هم شرکت کنندگان و هم فرد ارزیابی کننده کور هستند.
    مداخله بدلیل پاندمی کووید 19 در منزل بیمار انجام می شود. در این مطالعه هم شرکت کنندگان و هم فرد ارزیابی کننده کور هستند.
    Participants are included if they have age range between 30 and 50 , Medium disability score between 3 and 6 based on the "Expanded Disability Status Scale", Obtaining a minimum score of 21 from the Mini Mental Scale Examination, Willingness to participate in the study and sign the consent, having at least middle high school graduation to fill out self-declaration questionnaires
    Participants are included if they have age range between 30 and 50 , Medium disability score between 2 and 5 based on the "Expanded Disability Status Scale", Obtaining a minimum score of 21 from the Mini Mental Scale Examination, Willingness to participate in the study and sign the consent, having at least middle high school graduation to fill out self-declaration questionnaires
    افرادی وارد مطالعه می شوند که دارای سن بین30 تا 50 سال ، میزان ناتوانی در حد متوسط بین 3 تا 6 بر اساس معیار Expanded Disability Status Scale، کسب نمره حداقل 21 از پرسشنامه Mini Mental Scale Examination، تمایل به شرکت در مطالعه و امضای رضایتنامه، داشتن حداقل تحصیلات سوم راهنمایی به منظور پر کردن پرسشنامه های خود اظهاری، باشند.
    افرادی وارد مطالعه می شوند که دارای سن بین30 تا 50 سال ، میزان ناتوانی در حد متوسط بین 2 تا 5 بر اساس معیار Expanded Disability Status Scale، کسب نمره حداقل 21 از پرسشنامه Mini Mental Scale Examination، تمایل به شرکت در مطالعه و امضای رضایتنامه، داشتن حداقل تحصیلات سوم راهنمایی به منظور پر کردن پرسشنامه های خود اظهاری، باشند.

  • General information

    empty
    Researchers post pilot study realized that the range of disability that is measured by the EDSS should be more limited.َ Additionally, the interventions are performed in patient's house due to COVID-19 pandemic.
    empty
    پس از انجام مطالعه پایلوت مشخص شد که دامنه شدت ناتوانی که با EDSS اندازه گیری می شود، باید محدودتر شود. در ضمن، بدلیل پاندمی کووید 19، مداخلات در منزل انجام خواهد شد.
    Having age range between 30 and 50 years
    Having medium disability rates, between 3 and 6 base on the "Expanded Disability Status Scale"
    obtaining a minimum score of 21 base on the "Mini Mental Scale Examination"
    Willingness to participate in the study and sign the consent
    Having at least middle high school graduation to fill out self-declaration questionnaires
    Having age range between 30 and 50 years
    Having medium disability rates, between 2 and 5 base on the "Expanded Disability Status Scale"
    obtaining a minimum score of 21 base on the "Mini Mental Scale Examination"
    Willingness to participate in the study and sign the consent
    Having at least middle high school graduation to fill out self-declaration questionnaires
    دارا بودن سنی بین30 تا 50 سال
    میزان ناتوانی در حد متوسط بین3 تا 6 بر اساس معیار expanded disability status scale
    کسب نمره حداقل 21 از پرسشنامه Mini Mental Scale Examination
    تمایل به شرکت در مطالعه و امضای رضایت نامه
    داشتن حداقل تحصیلات سوم راهنمایی به منظور پر کردن پرسشنامه های خود اظهاری
    دارا بودن سنی بین30 تا 50 سال
    میزان ناتوانی در حد متوسط بین2 تا 5 بر اساس معیار expanded disability status scale
    کسب نمره حداقل 21 از پرسشنامه Mini Mental Scale Examination
    تمایل به شرکت در مطالعه و امضای رضایت نامه
    داشتن حداقل تحصیلات سوم راهنمایی به منظور پر کردن پرسشنامه های خود اظهاری

  • Primary outcomes

    #1
    "مقیاس اختلالات تنه"
    "مقیاس اختلال تنه"
    #2
    Balance score in "Berg Balance Scale" and "perturbation in Biodex balance system"
    The Balance score in "Berg Balance Scale" and sway in the "Biodex balance system"
    "Berg Balance Scale" and "perturbation in Biodex balance system"
    "Berg Balance Scale" and sway in the "Biodex balance system"

  • Secondary outcomes

    #1
    By asking the patient or their partner
    The number of falls by asking the patients or their care givers
    زمین خوردن با پرسش از خود فرد یا همراهانش
    تعداد زمین خوردن با پرسش از خود فرد یا مراقبینش

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Shohreh Noorizadeh Dehkordi
    Full name of responsible person - Persian: شهره نوری زاده دهکردی
    Position - English: Associate Professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 78
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
    Street address - Persian: ایران، تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 15459-13487
    Phone: +98 21 2222 7124
    Mobile: +98 912 372 3797
    Fax:
    Email: noorizadeh.sh@iums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Shohreh Noorizadeh Dehkordi
    Full name of responsible person - Persian: شهره نوری زاده دهکردی
    Position - English: Associate Professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
    Street address - Persian: ایران، تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 15459-13487
    Phone: +98 21 2222 7124
    Mobile: +98 912 372 3797
    Fax:
    Email: noorizadeh.sh@iums.ac.ir
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Shohreh Noorizadeh Dehkordi
    Full name of responsible person - Persian: شهره نوری زاده دهکردی
    Position - English: Associate Professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 78
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
    Street address - Persian: ایران، تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 15459-13487
    Phone: +98 21 2222 7124
    Mobile: +98 912 372 3797
    Fax:
    Email: noorizadeh.sh@iums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Shohreh Noorizadeh Dehkordi
    Full name of responsible person - Persian: شهره نوری زاده دهکردی
    Position - English: Associate Professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
    Street address - Persian: ایران، تهران، میرداماد، میدان مادر، خیابان شاه نظری، خیابان مددکاران، دانشکده علوم توانبخشی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 15459-13487
    Phone: +98 21 2222 7124
    Mobile: +98 912 372 3797
    Fax:
    Email: noorizadeh.sh@iums.ac.ir
    Web page address:

Protocol summary

Study aim
To determine the effect of dynamic neuromuscular stabilization exercises in comparison to core stability exercises on balance, falling and spasticity in people with multiple sclerosis
Design
This study is 2-armed, double-blind RCT compared dynamic neuromuscular stabilization exercise, to core stability exercises in some ambulant individuals with multiple sclerosis. this randomized clinical trial with one to one allocation in two groups (group 1: dynamic neuromuscular stabilization exercise, group 2: core stability exercise). Where the person evaluating the outcome measures is completely blind to the type of exercise each group received. In the case of patients, it is also expected that there will be no difference between the two groups in terms of exercise positions, and duration treatment sessions.
Settings and conduct
The intervention is performed in the patient's house because of COVID-19 pandemic. In this study, both the participants and the assessor are blind.
Participants/Inclusion and exclusion criteria
Participants are included if they have age range between 30 and 50 , Medium disability score between 2 and 5 based on the "Expanded Disability Status Scale", Obtaining a minimum score of 21 from the Mini Mental Scale Examination, Willingness to participate in the study and sign the consent, having at least middle high school graduation to fill out self-declaration questionnaires
Intervention groups
participants in intervention group, will receive "Dynamic neuromuscular stabilization exercise" and in control group, they will receive "core stability exercise" 5 weeks, three sessions per week.
Main outcome variables
The main outcomes are "trunk function" and "balance score".

General information

Reason for update
Researchers post pilot study realized that the range of disability that is measured by the EDSS should be more limited.َ Additionally, the interventions are performed in patient's house due to COVID-19 pandemic.
Acronym
IRCT registration information
IRCT registration number: IRCT20140222016680N5
Registration date: 2020-04-07, 1399/01/19
Registration timing: prospective

Last update: 2021-01-10, 1399/10/21
Update count: 3
Registration date
2020-04-07, 1399/01/19
Registrant information
Name
Shohreh Noorizadeh Dehkordi
Name of organization / entity
Iran University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
noorizadeh.sh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dynamic neuromuscular stabilization exercises in comparison to core stability exercises on balance, falling and spasticity in people with multiple sclerosis: a double blind randomized control trial
Public title
The effect of spine stabilizing exercises on balance and falling in people with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having age range between 30 and 50 years Having medium disability rates, between 2 and 5 base on the "Expanded Disability Status Scale" obtaining a minimum score of 21 base on the "Mini Mental Scale Examination" Willingness to participate in the study and sign the consent Having at least middle high school graduation to fill out self-declaration questionnaires
Exclusion criteria:
Suffering from other neurological disorders such as stroke, traumatic brain injury, Ataxia, etc Multiple sclerosis exacerbation during the last month Having apraxia (due to inability to learn and practice the exercises) Severe spasticity (score above 3 based on the "Modified Ashworth Scale") Having a history of major surgery in the lower extremities Explicit postural abnormalities in the spine and lower limbs such as scoliosis and kyphosis Having cardiovascular disease Having uncontrolled diabetes Pregnancy
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Random blocks (permuted block randomization) with four blocks will be used for randomization. According to the sample size of 66, approximately17 blocks will be generated using the online site (www.sealedenvelope.com). For concealment in the randomization process, unique code will be used on each envelope with the type of training specified inside.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, َََََََََََََََََAssessor who evaluates the outcome measures of study will be blind to the allocation of the two treatment groups. َAditionally the data also will be evaluated by a person who is blind to the allocation and treatment of groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-03-15, 1398/12/25
Ethics committee reference number
IR.IUMS.REC.1398.1358

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
Trunk function in "Trunk Impairment Scale"
Timepoint
A day before first treatment session, a day after 15th session (last session) and 3 months after the last session.
Method of measurement
"Trunk Impairment Scale"

2

Description
The Balance score in "Berg Balance Scale" and sway in the "Biodex balance system"
Timepoint
A day before first treatment session, a day after 15th session (last session) and 3 months after the last session.
Method of measurement
"Berg Balance Scale" and sway in the "Biodex balance system"

Secondary outcomes

1

Description
The number of falls by asking the patients or their care givers
Timepoint
A day before first treatment session, a day after 15th session (last session) and 3 months after the last session.
Method of measurement
by asking patients: "During last 6 months, how many times have you fallen?"

2

Description
Fear of falling by "Activities-specific Balance Confidence"
Timepoint
A day before first treatment session, a day after 15th session (last session) and 3 months after the last session.
Method of measurement
"Activities-specific Balance Confidence"

3

Description
Patient mobility by the "Multiple Sclerosis Walking Scale-12" and the "Timed Up and Go Test".
Timepoint
A day before first treatment session, a day after 15th session (last session) and 3 months after the last session.
Method of measurement
"Timed Up and Go" and "Multiple Sclerosis Walking Scale-12" and

4

Description
Spasticity score by "Multiple Sclerosis Spasticity Scale-88" and "Modified Ashworth Scale".
Timepoint
A day before first treatment session, a day after 15th session (last session) and 3 months after the last session.
Method of measurement
"Multiple Sclerosis Spasticity Scale-88" and "Modified Ashworth Scale"

Intervention groups

1

Description
Intervention group: In this group, Dynamic Neuromuscular Stabilization exercises, will be given in a period of 5 weeks, three sessions per week. During fifteen sessions, progressively 21 exercises are given with focus on improving trunk control in supine, prone, sitting, quadruped and standing positions. Each treatment session, depending on the patient needs to rest, lasts between 60 and 75 minutes. Required equipment are mats, gymnastics ball, chair.
Category
Rehabilitation

2

Description
Control group: Core Stability exercises a period of 5 weeks, will be given in a period of 5 weeks, three sessions per week. During fifteen sessions, progressively 16 exercises are given with focus on improving trunk control in supine, prone, sitting, and standing positions. Each treatment session, depending on the patient needs to rest, lasts between 60 and 75 minutes. Required equipment are mats, gymnastics balls, chair and wall bar.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neurological physiotherapy Clinic, School of Rehabilitation Sciences, Iran University of Medical sci
Full name of responsible person
Shohreh Noorizadeh Dehkordi
Street address
School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
noorizadeh.sh@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyyed Abbas Motevalian
Street address
Iran University of Medical Sciences, Hemmmat Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4704
Fax
+98 21 8862 2707
Email
amotevalian@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Cancellor for Research of Iran 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
Iran University of Medical Sciences
Full name of responsible person
Shohreh Noorizadeh Dehkordi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
noorizadeh.sh@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shohreh Noorizadeh Dehkordi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
noorizadeh.sh@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shohreh Noorizadeh Dehkordi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation Sciences, Madadkaran Street, Shahnazari Street, Madar Square, Mirdamad, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
noorizadeh.sh@iums.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
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