Protocol summary
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Study aim
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The effects of postural trainingwith cerebellar a-tDCS on balance, static and dynamic postural stability and fear of falling in patients with Multiple Sclerosis
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Design
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Clinical trials with control group, with parallel groups, Blind two-sided, randomized, without control with placebo, single center trial.
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Settings and conduct
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Neuromuscular Rehabilitation Research Center. Participants are divided into 3 groups. Individuals receive postural training on the biodex balance machine during two weeks and each week during 3 therapeutic sessions (20 minutes).
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Participants/Inclusion and exclusion criteria
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People with MS.
Inclusion criteria: 18-40 years; Expanded Disability Status Scale (EDSS) < 4.
Exclusion criteria: Severe visual field defect; Severe weakness in limb movement; Other neurologic disorders and neurological.
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Intervention groups
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Intervention group 1: According to the protocol, postural exercises are performed on the biodex machine with tDCS of the cerebellum.
Intervention group 2: According to the protocol, they perform postural exercises on the biodex machine with unrealistic cerebellar tDCS.
Control group: People will only receive postural exercises without receiving any electrical stimulation.
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Main outcome variables
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Fear Of Falling.
General information
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Reason for update
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According to the registration of the clinical trial on 2019/08/10, sampling started on 2019/08/23.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151228025732N43
Registration date:
2019-08-10, 1398/05/19
Registration timing:
prospective
Last update:
2021-05-11, 1400/02/21
Update count:
1
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Registration date
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2019-08-10, 1398/05/19
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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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2019-08-23, 1398/06/01
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Expected recruitment end date
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2020-01-15, 1398/10/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effects of postural trainingwith cerebellar a-tDCS on balance, static and dynamic postural stability and fear of falling in patients with Multiple Sclerosis
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Public title
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The effects of postural trainingwith cerebellar a-tDCS on balance, static and dynamic postural stability and fear of falling in patients with Multiple Sclerosis
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
18-40 years
Expanded Disability Status Scale (EDSS) < 4
Exclusion criteria:
Severe visual field defect
Severe weakness in limb movement
Other neurologic disorders and neurological
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Age
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From 18 years old to 40 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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- Participant
- Outcome assessor
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Sample size
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Target sample size:
66
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization; Individual; Random Number Tables.
Randomized permutation blocks (block 3).
Using Excel software to generate random number tables.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Study participants and evaluators are unaware of the allocation of study groups.
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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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2019-01-15, 1397/10/25
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Ethics committee reference number
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IR.SEMUMS.REC.1397.233
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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Fear Of Falling
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Timepoint
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Before, after and one month after intervention
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Method of measurement
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Falls Self-Efficacy Scale (FES-I) Questionnaire
Intervention groups
1
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Description
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Intervention group 1: According to the protocol, postural exercises are performed on the biodex machine with tDCS of the cerebellum.
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Category
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Diagnosis
2
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Description
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Intervention group 2: According to the protocol, they perform postural exercises on the biodex machine with unrealistic cerebellar tDCS.
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Category
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Diagnosis
3
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Description
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Control group: People will only receive postural exercises without receiving any electrical stimulation.
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Category
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Diagnosis
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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Yes
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Title of funding source
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Semnan University of Medical Sciences
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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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Yes - There is a plan to make this available
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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
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Title and more details about the data/document
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When the data will become available and for how long
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To whom data/document is available
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Only available to scholars working in academic institutions.
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Under which criteria data/document could be used
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In case of relevant studies.
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From where data/document is obtainable
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Fatemeh Ehsani Neuromuscular Rehabilitation Research Center, Ghods Blvd. +98 9191310755
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What processes are involved for a request to access data/document
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Comments
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