Protocol summary
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Study aim
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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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Design
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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
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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Intervention group 1:Static stretching exercises
Intervention group 2:Functional stretching exercises
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Main outcome variables
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pain, range of motion, spasticity, functional tests
General information
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Reason for update
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end of study
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Acronym
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IRCT registration information
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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
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Registration date
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2019-08-29, 1398/06/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-09-01, 1398/06/10
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Expected recruitment end date
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2019-12-29, 1398/10/08
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Actual recruitment start date
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2019-09-01, 1398/06/10
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Actual recruitment end date
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2019-12-01, 1398/09/10
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Trial completion date
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2019-12-01, 1398/09/10
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Scientific title
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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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Public title
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Effects of stretching exercises in patients with Multiple Sclerosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
22
Actual sample size reached:
24
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Each individual will be involved in a trial separately,will be assessed separately and will be treated separately.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-06-26, 1398/04/05
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Ethics committee reference number
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IR.USWR.REC.1398.051
Health conditions studied
1
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Description of health condition studied
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multiple sclerosis
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ICD-10 code
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G35
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ICD-10 code description
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Multiple sclerosis
Primary outcomes
1
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Description
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spasticity
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Timepoint
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in the begining and end of the study
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Method of measurement
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modified modified ashworth scale
2
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Description
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function
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Timepoint
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in the begining and end of the study
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Method of measurement
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Timed Up and Go test and Timed 25 Foot Walk test
3
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Description
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active range of motion
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Timepoint
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in the begining and end of the study
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Method of measurement
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with goniometer
4
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Description
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pain
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Timepoint
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in the begining and end of the study
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Method of measurement
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Visual analog scale
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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vice chancellery for research and technology of USWR
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no additional information.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available