1- To evaluate the effect of motor imagery practice on motor imagery ability
2-To evaluate the effect of motor imagery practice on upper-extremity rehabilitation in MS patients.
Design
clinical trial with a parallel control group of 37 multiple sclerosis patients; quasi randomized according to doctor choice; non-blinded
Settings and conduct
settings: A university affiliated neuroscience 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
1-Intervention group: The motor imagery training consisted of 10 sessions for 2 consecutive weeks (5 days a weak). During MI training, each action is imagined in the first person and the patient should not make actual movements.
2-Control group: no physical and mental training took place within these ten days in the control group.
Main outcome variables
1-Manual dexterity
2-Motor imagery ability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180902040927N4
Registration date:2018-10-20, 1397/07/28
Registration timing:retrospective
Last update:2018-10-20, 1397/07/28
Update count:0
Registration date
2018-10-20, 1397/07/28
Registrant information
Name
Mahdieh Azin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3131 5072
Email address
m.azin@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-12-30, 1395/10/10
Actual recruitment start date
2016-01-02, 1394/10/12
Actual recruitment end date
2016-12-30, 1395/10/10
Trial completion date
2017-09-22, 1396/06/31
Scientific title
The effect of upper extremity mental imagery exercise on rehabilitation of upper extremity motor imagery and movement in multiple sclerosis patients
Public title
The effect of mental training in multiple sclerosis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. 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 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
37
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman, Somayeh Road, Beginning ofJahad Boulevard, Alley No. 1,in front of the Besat Clinic, Neuroscience Research Center
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
IR.KUMS.REC.1393.1
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Manual dexterity according to completing of 9-Hole Peg Test (9-HPT)
Timepoint
before intervention and 10 days after intervention
Method of measurement
9-Hole Peg Test (9-HPT) evaluated manual dexterity in MS patients.
2
Description
Manual dexterity according to transferred cubes in The Box and Block Test (BBT)
Timepoint
before intervention and 10 days after intervention
Method of measurement
The Box and Block Test (BBT) evaluated manual dexterity in MS patients.
3
Description
Motor imagery ability based on score of Kinesthetic and Visual Imagery Questionnaire (KVIQ-20)
Timepoint
before intervention and 10 days after intervention
Method of measurement
Motor imagery ability was assessed by Kinesthetic and Visual Imagery Questionnaire (KVIQ-20).
4
Description
Motor imagery ability based on reaction time of hand mental rotation task (HMRT)
Timepoint
before intervention and 10 days after intervention
Method of measurement
Motor imagery ability was assessed hand mental rotation task (HMRT)
5
Description
Motor imagery ability based on response accuracy rate of hand mental rotation
Timepoint
before intervention and 10 days after intervention
Method of measurement
Motor imagery ability was assessed hand mental rotation task (HMRT).
6
Description
Motor imagery ability based on chronometry on BBT
Timepoint
before intervention and 10 days after intervention
Method of measurement
Motor imagery ability was assessed by chronometry on BBT .
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 70 minutes for each motor imagery (MI) training session split into two 30-minute periods of MI training via 10 minutes of rest. Session duration changed in response to patient feedback .For each MI training session, patients sat on a chair at a table in a position that: The hips, the knees and the ankles were at 90 degrees angle with straight sitting position; The forearms were on a resting state on the table without rising or falling shoulder girdle; During the MI training, patients held their hands position coordinated whit MI task (upward, downward, or in-between modes).
Category
Rehabilitation
2
Description
Control group: During the ten days of the experiment, no physical and mental exercises were performed and tests were performed without any intervention before and after ten days.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman MS Society
Full name of responsible person
Dr. Alireza Honarmand
Street address
Boulevard Kosar, adjacent to the Therapy Center , Unit 11 shafa
City
Kerman
Province
Kerman
Postal code
0
Phone
+98 34 3246 0718
Email
mahdieh.azin@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman neuroscience center
Full name of responsible person
Dr. Mohammad Shabani
Street address
Kerman, Somayeh Road, Beginning of Jahad Boulevard, Alley No. 1, in front of Besat Clinic
City
kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 4196
Fax
+98 34 3226 4198
Email
shabanimoh@yahoo.com
Grant name
Kerman neuroscience center
Grant code / Reference number
Grant number: KNRC/93-1
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman neuroscience center
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
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 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
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
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