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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
FES-I questionnaire, MSIS-29 questionnaire, Berg Balance Scale, Time Up and Go Test.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190902044672N1
Registration date:2019-10-23, 1398/08/01
Registration timing:registered_while_recruiting
Last update:2019-10-23, 1398/08/01
Update count:1
Registration date
2019-10-23, 1398/08/01
Registrant information
Name
Maryam Seddighi Khavidak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3822 9653
Email address
seddighi.m24@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-28, 1398/07/06
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of lavender as olfactory stimulus on balance and ADL of persons with multiple sclerosis: ( Randomized clinical trial)
Public title
The effect of lavender on balance a persons with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Using a block randomization, participants are randomly assigned to a experimental or control groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
3th Floor, Medical School, Evin Blvd., Shahid Chamran Hwy., Tehran
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2019-01-20, 1397/10/30
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.1004
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
balance
Timepoint
balance measurement at the beginning of the study and after 10 sessions.
Method of measurement
Balance measurement are performed using the berg balance scale.
2
Description
Dynamic balance
Timepoint
dynamic balance measurement at the beginning of the study and after 10 sessions.
Method of measurement
dynamic Balance measurement are performed using the Time Up and Go Test.
Secondary outcomes
1
Description
fear of fall
Timepoint
Measurement of fear of falling before the beginning of the study and after 10 sessions.
Method of measurement
Fear of falling is measured using the Falling Efficiency Scale questionnaire.
2
Description
Independence in activity of daily living
Timepoint
Measurement of Independence in activity of daily living before the beginning of the study and after 10 sessions.
Method of measurement
Independence in activity of daily living is measured using the Multiple Sclerosis Impact Scale-29 questionnaire.
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
Control group: Vestibular Rehabilitation exercise protocol are carried out during three exercise sessions, alternate days, with a total of 10 sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran MS society
Full name of responsible person
Abolqhasem Najafi
Street address
No. 35, Shams Alley, Vesal Shirazi Ave., Engelab Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1416864731
Phone
+98 21 6695 3907
Email
iranmsociety@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran MS society
Full name of responsible person
Seyed Khosro-sadegh Mosavi
Street address
No. 35, Shams Alley., Vesal Shirazi Ave., Enghelab Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1416864731
Phone
+98 21 6695 3907
Email
iranmsociety@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
What processes are involved for a request to access data/document
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.