Evaluating the effect of the Functionally Oriented Music Therapy on motor and cognitive skills in children with specific learning disability.
Design
Randomized clinical trial with a with blinded outcome assessment
Settings and conduct
Through interview with parents whose children has been registered in learning disability centers , samples with inclusion criteria and a letter of consent will be selected. Using random digit tables, samples will be divided into experimental and control group. Assessments includes Clinical Observation of Motor and Postural Skills, Bruininks-Oseretsky Test of Motor Proficiency, Wechsler Memory Scale and Continuous Performance Test will be taken from 26 participants. Behavior Rating Inventory of Executive Function will be answered by parents. The assessments is conducted by blinded/trained elevators.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Specific learning disability diagnosed by experts,
َAge 7- 11 years,
Education at least fifth grade and ability of reading, writing and speaking in Persian for respondent parent.
Exclusion criteria:
Untreated physical, visual and auditory impairments,
Co-morbidity of attention deficit-hyper activity disorder,
Co-morbidity of problem behaviors
Intervention groups
The experimental group will receive the Functionally Oriented Music Therapy (FMT) in which specific melody structures are played on a piano by the therapist and the client plays on certain drums and cymbals. Treatment will be implemented individually and there is no oral instruction. The sessions will take 4 months, 16 sessions and 1 day per week for 20 minutes per session. The control group will not receive any intervention.
The effect of Functionally Oriented Music Therapy on motor and cognitive skills in children with specific learning disability
Public title
Functionally Oriented Music Therapy in Learning disability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Specific learning disability diagnosed by expert
Age 7- 11 years
Education at least fifth grade and ability of reading, writing and speaking in Persian for respondent parent
Exclusion criteria:
Untreated physical, visual and auditory impairments
Co-morbidity of attention deficit-hyper activity disorder
Co-morbidity of problem behaviors
Age
From 7 years old to 11 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling is convenience and based on inclusion criteria. Then samples are assigned randomly into two groups of experimental and control through random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessors who are allocated to gather data.
Placebo
Not used
Assignment
Parallel
Other design features
Functionally Oriented Music Therapy, FMT, belongs to Sweden. It will be utilized with the permission of its developers and by providing the maximum principles of original version out of Sweden.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sceinces
Street address
School of Rehabilitation Sciences, Iran University of Medical Sciences, Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
15459-13487
Approval date
2019-12-16, 1398/09/25
Ethics committee reference number
IR.IUMS.REC.1398.974
Health conditions studied
1
Description of health condition studied
Specific Learning Disability
ICD-10 code
R48
ICD-10 code description
Dyslexia and other symbolic dysfunctions, not elsewhere classified
Primary outcomes
1
Description
Changes in sustained attention, ability to maintain consistent behavioral response during a repetitive or continues task.
Timepoint
Before and after the intervention
Method of measurement
Continuous performance Test (CPT), software version
2
Description
Changes in memory capacity (7+/-2)
Timepoint
Before and after the intervention
Method of measurement
Wechsler Working Memory Scale (WMS)
3
Description
Changes in executive function
Timepoint
Before and after the intervention
Method of measurement
Behavior Rating Inventory of Executive Function( BRIEF)
4
Description
Changes in motor- postural skills
Timepoint
Before and after the intervention
Method of measurement
Clinical Observation of Motor and Postural Skills (COMPS)
5
Description
Changes in gross and fine motor skills
Timepoint
Before and after the intervention
Method of measurement
Bruininks-Oseretsky Test of Motor Proficiency (BOT), Sub scale of gross and fine motor skills
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group will receive FMT approach in which specific melody structures are played on acoustic piano by the therapist to stimulate the overall natural development of fundamental function in the body of the client. Treatment is implemented individually and thr client will be developed in motor, cognitive, perception and emotion areas by playing on certain drums and cymbals. The approach has no oral instruction at all, instead melody structures are used to stimulate the client's natural development. The length of each session is 20 minutes which will be done for 16 sessions weekly.
Category
Treatment - Other
2
Description
Control group: This group will not receive any specific intervention
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The center of education and rehabilitation for specific learning disabilities 1, Due to the SNEO
School of Rehabilitation Sciences, Iran University of Medical Sciences, Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
kamyab.m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Samaneh Karamali Esmaili
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
School of Rehabilitation Sciences, Iran University of Medical Sciences, Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
esmaeili.s@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mitra Khalafbeigi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
School of Rehabilitation Sciences, Iran University of Medical Sciences, Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
khalafbeigi.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mitra Khalafbeigi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
School of Rehabilitation Sciences, Iran University of Medical Sciences, Maddadkaran St., Shahid Nazari St., Mother Square, Mirdamad Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 7124
Email
khalafbeigi.m@iums.ac.ir
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
There is no more information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data that are related to primary outcome will be available.
When the data will become available and for how long
Immediately after publication.
To whom data/document is available
Researchers working in academic institutions.
Under which criteria data/document could be used
With permission of developers of approach in Sweden.
From where data/document is obtainable
The head director of FMT education center.
Elin Svanström
info@fmtutbildning.se
What processes are involved for a request to access data/document