Comparison of clinical and functional effects of static stretching and functional stretching exercises in lower limb muscles of patients with Multiple Sclerosis
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General information
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24
24
2019-06-29, 1398/04/08
2019-09-01, 1398/06/10
2019-0609-2901 00:00:00
empty
2019-09-01, 1398/06/10
2019-09-01 00:00:00
empty
2019-12-01, 1398/09/10
2019-12-01 00:00:00
empty
2019-12-01, 1398/09/10
2019-12-01 00:00:00
empty
end of study
end of study
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تمام شدن مطالعه
تمام شدن مطالعه
Recruitment centers
#1
Name of recruitment center - English: Iran MS society
Name of recruitment center - Persian: انجمن مولتیپل اسکروزیس ایران
Full name of responsible person - English: Abolghasem najafi
Full name of responsible person - Persian: ابوالقاسم نجفی
Street address - English: Enqelab street,vassal shirazi street,shams alley,No. 35
Street address - Persian: خیابان انقلاب، خیابان وصال شیرازی نرسیده به چهارراه طالقانی، کوچه شهید محمد شمس،پلاک۳۵
City - English: tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1416864731
Phone: +98 21 6695 1187
Fax:
Email: iranmsociety@gmail.com
Web page address: http://www.iranms.ir/fa
Name of recruitment center - English: Iran MS society
Name of recruitment center - Persian: انجمن مولتیپل اسکروزیس ایران
Full name of responsible person - English: Abolghasem najafi
Full name of responsible person - Persian: ابوالقاسم نجفی
Street address - English: No. 35, Shams Alley, Vassal Shirazi Street, Enqelab Street
Street address - Persian: خیابان انقلاب، خیابان وصال شیرازی نرسیده به چهارراه طالقانی، کوچه شهید محمد شمس، پلاک۳۵
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1416864731
Phone: +98 21 6695 1187
Fax:
Email: iranmsociety@gmail.com
Web page address: http://www.iranms.ir/fa
Name of recruitment center - English: Iran MS society Name of recruitment center - Persian: انجمن مولتیپل اسکروزیس ایران Full name of responsible person - English: Abolghasem najafi Full name of responsible person - Persian: ابوالقاسم نجفی Street address - English: Enqelab street,vassal shirazi street,shams alley,NoNo. 35, Shams Alley, Vassal Shirazi Street, Enqelab Street Street address - Persian: خیابان انقلاب، خیابان وصال شیرازی نرسیده به چهارراه طالقانی، کوچه شهید محمد شمس،پلاک۳۵ City - English: tehranTehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1416864731 Phone: +98 21 6695 1187 Fax: Email: iranmsociety@gmail.com Web page address: http://www.iranms.ir/fa
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Mohammad Reza Khodaei Ardakani
Full name of responsible person - Persian: دکتر محمد رضاخدایی اردکانی
Street address - English: Koodakyar Ave., Evin, Tehran, Iran,
Street address - Persian: اوین - بلوار دانشجو - خیابان کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 7173 2889
Fax: +98 21 7173 2889
Email: Kh.ardakani@uswr.ac.ir
Web page address: http://en.uswr.ac.ir/index.jsp?fkeyid=&siteid=2&fkeyid=&siteid=56&pageid=13761
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.Mohammad Reza Khodaei Ardakani
Full name of responsible person - Persian: دکتر محمد رضاخدایی اردکانی
Street address - English: Koodakyar Ave., Evin, Tehran, Iran
Street address - Persian: اوین, بلوار دانشجو, خیابان کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 7173 2889
Fax: +98 21 7173 2889
Email: Kh.ardakani@uswr.ac.ir
Web page address: http://en.uswr.ac.ir/index.jsp?fkeyid=&siteid=2&fkeyid=&siteid=56&pageid=13761
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr.Mohammad Reza Khodaei Ardakani Full name of responsible person - Persian: دکتر محمد رضاخدایی اردکانی Street address - English: Koodakyar Ave., Evin, Tehran, Iran, Street address - Persian: اوین -, بلوار دانشجو -, خیابان کودکیار City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1985713834 Phone: +98 21 7173 2889 Fax: +98 21 7173 2889 Email: Kh.ardakani@uswr.ac.ir Web page address: http://en.uswr.ac.ir/index.jsp?fkeyid=&siteid=2&fkeyid=&siteid=56&pageid=13761
Protocol summary
Study aim
Comparison of clinical and functional effects of static stretching and functional stretching exercises in lower limb muscles of patients with Multiple Sclerosis
Design
Randomized,single blinded trial with parallel group design of 22 patients with Multiple sclerosis allocated randomly into two static stretching and functional stretching exercises group
Settings and conduct
Pre and post assessments in each group are as follows: ROM assessment, pain intensity, spasticity and functional tests (TUG, T25FWT).
For patients in static stretching group; hamistring, quadrceps, hip adductors and plantar flexors muscles will be stretched statically by therapist.
For patients in functional stretching group; hamistring, quadrceps, hip adductors and plantar flexors will be stretched by patients actively with guidance of therapist.
In both group each stretch will be kept for 30 sec and repeated 3 times with 15 sec rests.
In both group after stretching ,active or active assisted movements in the same direction of stretching will be done with 5 repetition.
Participants/Inclusion and exclusion criteria
Inclusion criteras: to have multiple sclerosis disease confirmed by specialist; to have spasticity with limb stiffness or contractures of muscles or soft tissue in lower extremity; being able to walk min 25 foot with/without assistive devices.
Exclusion criterias: to use wheelchair; to use anti spasticity drugs.
Intervention groups
Intervention group 1:Static stretching exercises
Intervention group 2:Functional stretching exercises
Main outcome variables
pain, range of motion, spasticity, functional tests
General information
Reason for update
end of study
Acronym
IRCT registration information
IRCT registration number:IRCT20190702044079N1
Registration date:2019-08-29, 1398/06/07
Registration timing:prospective
Last update:2020-01-19, 1398/10/29
Update count:1
Registration date
2019-08-29, 1398/06/07
Registrant information
Name
Merziye ergul
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4424 1362
Email address
merziyeergul@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-01, 1398/06/10
Expected recruitment end date
2019-12-29, 1398/10/08
Actual recruitment start date
2019-09-01, 1398/06/10
Actual recruitment end date
2019-12-01, 1398/09/10
Trial completion date
2019-12-01, 1398/09/10
Scientific title
Comparison of clinical and functional effects of static stretching and functional stretching exercises in lower limb muscles of patients with Multiple Sclerosis
Public title
Effects of stretching exercises in patients with Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Multiple sclerosis confirmed by specialist
to have spasticity with limb stiffness or contractures of muscles or soft tissue in lower extremity
being able to walk min 25 foot with/without assistive devices
Exclusion criteria:
to use wheelchair
to use anti spasticity drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
22
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by random allocation rule through lottery:for this study,for a total study size of 22;11 paper for static stretching group and 11 paper for functional stretching group will be put in a lottery pocket.Then for each patient one paper will be drawn randomly from pocket and patients will be randomly allocated into static and functional stretching groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Each individual will be involved in a trial separately,will be assessed separately and will be treated separately.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of University of Social Welfare and Rehabilitation Sciences
Street address
Kodekeyar dead end, Daneshjo Blvd, Evin
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Approval date
2019-06-26, 1398/04/05
Ethics committee reference number
IR.USWR.REC.1398.051
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
spasticity
Timepoint
in the begining and end of the study
Method of measurement
modified modified ashworth scale
2
Description
function
Timepoint
in the begining and end of the study
Method of measurement
Timed Up and Go test and Timed 25 Foot Walk test
3
Description
active range of motion
Timepoint
in the begining and end of the study
Method of measurement
with goniometer
4
Description
pain
Timepoint
in the begining and end of the study
Method of measurement
Visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:static stretching exercises will be applied 3 times in a week totally for 4 weeks.Hamistring,quadriceps,adductors and plantar flexors will be streched by researcher bilaterally.Each stretch will be kept for 30 seconds and repeated for 3 times.
Category
Rehabilitation
2
Description
Intervention group:functional stretching exercises will be done 3 times in a week totally for 4 weeks.Hamistring,quadriceps,adductors and plantar flexors will be streched by patient with guidance of reseacher.Each stretch will be kept for 30 seconds and repeated for 3 times.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran MS society
Full name of responsible person
Abolghasem najafi
Street address
No. 35, Shams Alley, Vassal Shirazi Street, Enqelab Street
City
Tehran
Province
Tehran
Postal code
1416864731
Phone
+98 21 6695 1187
Email
iranmsociety@gmail.com
Web page address
http://www.iranms.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences