* Determining and comparing hand function in multiple sclerosis patients before and after intervention in two intervention and control groups
* Determining and comparing hand strength (grip strength) in multiple sclerosis patients before and after the intervention in two groups.
* Determining and comparing hand strength (pinch between thumb and index finger pad) in multiple sclerosis patients before and after intervention in two groups.
* Determination and comparison of fatigue in multiple sclerosis patients before and after the intervention in two intervention and control groups
Design
A clinical trial with a control group, with parallel groups, a blind strain, non-randomized, phase 3 on 30 patients.
Settings and conduct
The sessions will be individual. the patient carefully watches the videos including the tasks and activities performed with the upper limbs and hands, the written instructions, and the number of repetitions. After watching the movie, he imitates and executes the tasks and activities he has seen.
The place of conducting is the occupational therapy clinic of Ahvaz Rehabilitation Faculty.
The outcome assessor and the data analyst do not know whether the assessed person is in the control group or in the intervention group
Participants/Inclusion and exclusion criteria
People with MS who have more affected on one side of their upper limb and less than 10 years have passed since they got the disease.
People who do not want to participate in the intervention or fill in the information incompletely will be excluded from the intervention.
Intervention groups
The control group received the usual physiotherapy interventions, and the intervention group received 12 sessions of occupation-based AO interventions in addition to physical therapy. The interventions are 3 sessions per week for 45-60 minutes.
Main outcome variables
hand function, strength, and fatigue in individuals with MS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240302061148N1
Registration date:2024-06-04, 1403/03/15
Registration timing:registered_while_recruiting
Last update:2024-06-04, 1403/03/15
Update count:0
Registration date
2024-06-04, 1403/03/15
Registrant information
Name
Fatemeh Savaedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4822 6676
Email address
f-savaedi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-25, 1403/03/05
Expected recruitment end date
2024-07-26, 1403/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Action Observation Training on hand function, strength and fatigue in individuals with Multiple Sclerosis
Public title
Effect of Action Observation Training on hand function, strength and fatigue in individuals with Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with MS between the ages of 18 and 63
have problems with hand function and performing daily activities.
According to the EDSS scale, they receive a score of 6.
Patients who have more weakness on one side of their body feel weaker and are unable to do things with that hand
The duration of the disease is less than 10 years.
Do not have neurological problems, other related diseases, or issues with sensation, comprehension (apraxia), vision, or hearing.
The patient can participate in the study if their vision is corrected with glasses and their hearing is corrected with hearing aids.
Obtaining a score of at least 23 on the MMSE test
Exclusion criteria:
Incomplete information in demographic information forms or evaluation questionnaires
Non-referral and lack of cooperation from the patient throughout the treatment
Absence from more than three treatment sessions
Experiencing MS attacks during treatment
Age
From 18 years old to 63 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome evaluator is blinded to whether the individual is in the intervention group or the control group. The data analyst is also blinded to whether the information is related to the control group or the intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz JondiShapour University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences Campus, Faculty of Rehabilitation
City
Ahvaz
Province
Khouzestan
Postal code
6471764544
Approval date
2024-04-24, 1403/02/05
Ethics committee reference number
IR.AJUMS.REC.1403.020
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G37.3
ICD-10 code description
Acute transverse myelitis in demyelinating disease of central nervous system
Primary outcomes
1
Description
The hand function score; a higher score on this questionnaire indicates greater impairment in hand function
Timepoint
At the beginning of the study and after 12 intervention sessions
Method of measurement
Arm Function in Multiple Sclerosis Questionnaire (AMSQ): This questionnaire contains 31 items assessing hand and upper limb function, utilizing a 6-point scale from 1 (no limitation in activity at all) to 6 (not able to perform the activity). A higher score on this questionnaire indicates greater impairment in hand function.
2
Description
Fatigue Severity Scale - The Fatigue Severity Scale (FSS) is a 9-item scale that measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders.
Timepoint
At the beginning of the study and after 12 intervention sessions
Method of measurement
FSS: This scale evaluates the intensity of fatigue in people with MS on a 7-point scale from 1 (completely disagree) to 7 (completely agree). According to the scoring system outlined in this questionnaire, a score below 36 indicates no fatigue, while a score of 36 and above requires evaluation by a doctor.
3
Description
grip power
Timepoint
At the beginning of the study and after 12 intervention sessions
Method of measurement
Dynamometer
4
Description
Pinch strength (strength between thumb and forefinger)
Timepoint
At the beginning of the study and after 12 intervention sessions
Method of measurement
Pinch gauge
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine physiotherapy interventions, patients in the intervention group receive Action Observation treatment for 12 sessions, with each session lasting 1 hour.
Category
Rehabilitation
2
Description
Control group: Patients in the control group only received routine physiotherapy interventions for 12 sessions, with each session lasting 1 hour.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Khuzestan MS Association
Full name of responsible person
DR. Nastaran Majdinasab
Street address
Ahvaz Jundishapur University of Medical Sciences Campus, Faculty of Rehabilitation
City
Ahvaz
Province
Khouzestan
Postal code
6135733133
Phone
+98 61 3374 3660
Email
ahvaz-rehab@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehrnoush Zakerkish
Street address
Golestan Blvd., University City, Jundishapur University of Medical Sciences, Ahvaz Research and Technology Development Vice
City
Ahvaz
Province
Khouzestan
Postal code
6135715756
Phone
+98 61 3373 8383
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mahsa Fadavi-Ghaffari
Position
Faculty member of Ahuz University of Medical Sciences (Lecturer))
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Ahvaz Jundishapur University of Medical Sciences Campus, Faculty of Rehabilitation
City
Ahvaz
Province
Khouzestan
Postal code
6136843847
Phone
+98 61 3374 3101
Email
mahsafadavimsc93@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahsa Fadavi-Ghaffari
Position
Member of the academic faculty of Jundishapur Ahvaz University of Medical Sciences (lecturer))
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Ahvaz Jundishapur University of Medical Sciences Campus, Faculty of Rehabilitation
City
Ahvaz
Province
Khouzestan
Postal code
6136843847
Phone
+98 61 3374 3101
Email
mahsafadavimsc93@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Savaedi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Ahvaz Jundishapur University of Medical Sciences Campus, Faculty of Rehabilitation
City
Ahvaz
Province
Khouzestan
Postal code
6471764544
Phone
+98 61 3374 3101
Email
fatemeh.savaedi2000@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available