Protocol summary
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Study aim
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The effect of lavender as olfactory stimulus on balance and ADL of persons with multiple sclerosis
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Design
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Two-arm parallel group, ten-session treatment, randomized clinical trial.
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Settings and conduct
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Thirty six ambulatory MS patients are selected from among the patients who will be referred to the physiotherapy departments of Iran MS Society in 2019. Using a block randomization, participants are randomly assigned to an Experimental Group (EG) or Control Group (CG). EG received program based Vestibular Rehabilitation exercise protocol along with olfactory stimulus. CG
received Vestibular Rehabilitation exercise protocol without olfactory stimulation.
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Participants/Inclusion and exclusion criteria
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patients with relapsing–remitting or secondary-progressive types of MS, clinically definite MS, being in remission period, being between the ages of 18 and 60 years, ability to stand for 30 seconds and to walk a distance of 6 m without any assistance, to have a Berg Balance Scale (BBS) score of 21–44, had normal olfactory function diagnosed with an olfactory identification test, no allergy to lavender, did not have any disease in musculoskeletal and cardiovascular system, not suffering from any other neurological diseases other than MS, showed no problem in communication, and agreed to voluntarily participate in the present research.
unwilling or unable to participate in the research
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Intervention groups
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Experimental Group : received a standardized program based on Vestibular Rehabilitation (VR) exercise protocol along with olfactory stimulus (through a mask containing 3 drops of lavender essential oil (2% concentration)).
Control Group: received a standardized program based on Vestibular Rehabilitation (VR) exercise protocol without olfactory stimulation.
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Main outcome variables
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FES-I questionnaire, MSIS-29 questionnaire, Berg Balance Scale, Time Up and Go Test.
General information
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Reason for update
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1- Increasing the sample size due to insufficient intergroup differences
2- The start date of the study was done after the registration date.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190902044672N1
Registration date:
2019-10-23, 1398/08/01
Registration timing:
prospective
Last update:
2020-05-18, 1399/02/29
Update count:
1
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Registration date
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2019-10-23, 1398/08/01
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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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2019-10-30, 1398/08/08
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Expected recruitment end date
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2020-02-19, 1398/11/30
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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 lavender as olfactory stimulus on balance and ADL of persons with multiple sclerosis: ( Randomized clinical trial)
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Public title
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The effect of lavender on balance a persons 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:
clinically definite multiple sclerosis
the ages between 18 and 60 years
ability to stand for 30 seconds and to walk a distance of 6 m without any assistance
have a Berg Balance Scale score of 21–44
being in remission period
did not have any disease in cognitive, musculoskeletal and cardiovascular system, not suffering from any other neurological diseases other than MS
had normal olfactory function
no allergy to lavender
Exclusion criteria:
unwilling or unable to participate in the research
disease relapse during the study
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Age
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From 18 years old to 60 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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No information
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Using a block randomization, participants are randomly assigned to a experimental or control groups.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2019-01-20, 1397/10/30
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1397.1004
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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balance
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Timepoint
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balance measurement at the beginning of the study and after 10 sessions.
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Method of measurement
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Balance measurement are performed using the berg balance scale.
2
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Description
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Dynamic balance
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Timepoint
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dynamic balance measurement at the beginning of the study and after 10 sessions.
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Method of measurement
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dynamic Balance measurement are performed using the Time Up and Go Test.
Secondary outcomes
1
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Description
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fear of fall
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Timepoint
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Measurement of fear of falling before the beginning of the study and after 10 sessions.
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Method of measurement
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Fear of falling is measured using the Falling Efficiency Scale questionnaire.
2
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Description
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Independence in activity of daily living
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Timepoint
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Measurement of Independence in activity of daily living before the beginning of the study and after 10 sessions.
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Method of measurement
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Independence in activity of daily living is measured using the Multiple Sclerosis Impact Scale-29 questionnaire.
Intervention groups
1
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Description
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Intervention group: Vestibular Rehabilitation exercise protocol are carried out during three exercise sessions, alternate days, with a total of 10 sessions while the olfactory stimulus is applied to the nose of the patients through a mask containing 3 drops of lavender essential oil.
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Category
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Rehabilitation
2
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Description
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Control group: Vestibular Rehabilitation exercise protocol are carried out during three exercise sessions, alternate days, with a total of 10 sessions.
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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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Iran MS society
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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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Private
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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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Persons
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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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Individual data of subjects in relevant to outcome measured
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When the data will become available and for how long
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Start of access period 3 months after printing results
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To whom data/document is available
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All researchers studying neurological diseases
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Under which criteria data/document could be used
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Itis depended on the request of resurcher
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From where data/document is obtainable
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Maryam Seddighi Khavidak. Phone number: 09135195444
Email: ms_kh1994@yahoo.com
Address: No. 4, 8th Alley., Sorosh St., Yasin St., Pasdaran Blvd
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What processes are involved for a request to access data/document
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The researchers have to e-mail a request to the responder. After reviewing and identifying the researcher's purpose, the responder will be sended the information to them.
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Comments
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