The effects of repetitive tactile stimulation on upper limb sensory - motor function, hand motor imagery and cognitive function in multiple sclerosis patients
Determining the effect of tactile stimulation on the sensory and motor function of the upper extremity, the hand motor imagery ability and the cognitive function of multiple sclerosis patients
Design
Quasi randomized,single- blinded, sham controlled clinical trial with a parallel group
Settings and conduct
Rafsanjan cohort studies center
Participants/Inclusion and exclusion criteria
1-They were right-handed according to Edinburg Handedness Inventory;
2. Their disease had remained stable in the last three months before the examination;
3. They were not affected with other brain diseases such as stroke, traumatic brain injury, seizure, and mental retardation;
4. Patients’ scores in the cognitive assessment based on Mini Mental State Examination were above 24;
5. Patients' disability according to the Kurtzke Expanded Disability Status Scale (EDSS) was less than 3.5
Intervention groups
Intervention group: implementation of tactile stimulation for 30 minutes
Control group: The tactile stimulation device have was turned off.
The effects of repetitive tactile stimulation on upper limb sensory - motor function, hand motor imagery and cognitive function in multiple sclerosis patients
Public title
The effect of tactile stimulation on multiple sclerosis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
They were definitely diagnosed with MS according to neurological examinations by a specialist based on the international revised McDonald’s Criteria.
These individuals belonged to relapsing remitting MS sub-group based on the National MS Society division
Exclusion criteria:
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
single blinds:Participants were unaware of the intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of rafsanjan university of medical sciences
Street address
Rafsanjan University of Medical Sciences, School of Medicine, Pistachio Street, Gulf Blvd., Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7718175911
Approval date
2017-07-16, 1396/04/25
Ethics committee reference number
IR.RUMS.REC.1396.140
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
Two-point discrimination threshold
Timepoint
Before and after tactile stimulation
Method of measurement
A self-made Two-point threshold detection device
2
Description
The upper extremity function by 9HPT
Timepoint
Before and after tactile stimulation
Method of measurement
Nine hole peg test
3
Description
The upper extremity function by BBT
Timepoint
Before and after tactile stimulation
Method of measurement
Box and block test
4
Description
Reaction time of hand mental rotation
Timepoint
Before and after tactile stimulation
Method of measurement
Hand mental rotation task
5
Description
Response accuracy rate of hand mental rotation
Timepoint
Before and after tactile stimulation
Method of measurement
Hand mental rotation task
6
Description
PASAT score
Timepoint
Before and after tactile stimulation
Method of measurement
Paced Auditory Serial Addition Test (PASAT)
7
Description
Score of SDMT
Timepoint
Before and after tactile stimulation
Method of measurement
Symbol Digit Modalities Test (SDMT)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 30 minutes of tactile stimulation of the right index finger was applied
Category
Rehabilitation
2
Description
Control group: the tactile stimulation device was turned off.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Special Patients Clinic in Rafsanjan
Full name of responsible person
Dr. Ranjbar
Street address
Special Patients Clinic in Rafsanjan, opposite Tarehbar Square, Pistachio Street, Persian Gulf Blvd.
City
Rafsanjan
Province
Kerman
Postal code
0
Phone
+98 34 3428 0045
Email
darman@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Ali Shamsizadeh
Street address
Central Organization, Imam Ali Blvd, Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
alishamsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mahdieh Azin
Position
Assistant Professor of Neuroscience
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Rafsanjan University of Medical Sciences, Faculty of Medicine, Pistachio St., Persian Gulf Blvd., Rafsanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
0
Phone
+98 34 3131 5079
Fax
Email
mahdieh.azin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mahdieh Azin
Position
Assistant Professor of Neuroscience
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Faculty of Medicine, Rafsanjan University of Medical Sciences, Pistachio St., Persian Gulf Blvd., Rafsanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
0
Phone
+98 34 3131 5079
Fax
Email
mahdieh.azin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mahdieh Azin
Position
Assistant Professor of Neuroscience
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Faculty of Medicine, Rafsanjan University of Medical Sciences, Pistachio St., Persian Gulf Blvd., Rafsanjan, Iran
City
Rafsanjan
Province
Kerman
Postal code
0
Phone
+98 34 3131 5079
Fax
Email
mahdieh.azin@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD