Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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The main outcomes are "trunk function" and "balance score".
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20140222016680N5
Registration date:
2020-04-07, 1399/01/19
Registration timing:
prospective
Last update:
2021-11-18, 1400/08/27
Update count:
3
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Registration date
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2020-04-07, 1399/01/19
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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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2020-04-20, 1399/02/01
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Expected recruitment end date
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2021-10-10, 1400/07/18
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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 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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Public title
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The effect of spine stabilizing exercises on balance and falling in people 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:
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
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Age
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From 30 years old to 50 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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- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
64
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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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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2020-03-15, 1398/12/25
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Ethics committee reference number
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IR.IUMS.REC.1398.1358
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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The Balance score in "Berg Balance Scale"
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Timepoint
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A day before first treatment session, a day after 15th session (last session) and 3 months after the last session.
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Method of measurement
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"Berg Balance Scale "
Secondary outcomes
1
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Description
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The number of falls by asking the patients or their care givers
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Timepoint
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A day before first treatment session, a day after 15th session (last session) and 3 months after the last session.
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Method of measurement
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by asking patients: "During last 6 months, how many times have you fallen?"
2
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Description
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Fear of falling by "Activities-specific Balance Confidence"
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Timepoint
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A day before first treatment session, a day after 15th session (last session) and 3 months after the last session.
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Method of measurement
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"Activities-specific Balance Confidence"
3
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Description
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Patient mobility by the "Multiple Sclerosis Walking Scale-12" and the "Timed Up and Go Test".
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Timepoint
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A day before first treatment session, a day after 15th session (last session) and 3 months after the last session.
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Method of measurement
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"Timed Up and Go" and "Multiple Sclerosis Walking Scale-12" and
4
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Description
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Spasticity score by "Multiple Sclerosis Spasticity Scale-88" and "Modified Ashworth Scale".
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Timepoint
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A day before first treatment session, a day after 15th session (last session) and 3 months after the last session.
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Method of measurement
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"Multiple Sclerosis Spasticity Scale-88" and "Modified Ashworth Scale"
5
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Description
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"sway in the "Biodex balance system"
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Timepoint
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A day before first treatment session, a day after 15th session (last session) and 3 months after the last session.
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Method of measurement
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sway in the "Biodex balance system"
6
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Description
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Trunk function in "Trunk Impairment Scale"
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Timepoint
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A day before first treatment session, a day after 15th session (last session) and 3 months after the last session.
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Method of measurement
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"Trunk Impairment Scale"
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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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 Cancellor for Research of Iran 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available