History
# Registration date Revision Id
2 2021-02-24, 1399/12/06 172500
1 2018-02-14, 1396/11/25 37028
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
The comparison of “cognitive orientation to daily occupational performance (CO-OP)” with current treatment approach (CTA) on motivation and participation of 8-12 years old children with cerebral palsy
Design
Clinical, Randomized, Tripple-blind trial with two parallel group
Settings and conduct
After approval of the proposal, the ethical code is drawn up. Iran univercity of medical science introduce the researcher to exceptional education organization for recieving license to enter to schools. We will communicate with the families and invite them to examine the child condition and inclusion criteria by Gross motor function classification system (GMFCS), The Manual Ability Classification System (MACS) and colored Raven intelligence scale. we randomize children to groups of A & B (A: CO-OP and B: CTA). people in group A, will choose three intervention goal with parent and child by using Candian Occupational Performance Model (COPM) and will receive twelve 45-minute sessions of intervention on average twice per week. In group B, children recieve 12 sessions of traditional treatment of occupational therapy. To assess volition, we will use "pediatric volitional questionnaire 2.1" that is an observational questionnaire, will fill by a blinded assessor in Pre and post treatment & session 6. This assessor will observe child behavior in the film recorded. The "Pediatric motivation" (PMOT) scale, assesses motivation from children perspective during therapy session. The questionnaire will be filled by the child in sessions 1, 3,7,11 and 12. "Dimensions of mastery questionnaire(DMQ) parent proxy-report" and "Life habit questionnaire" (LIFE_H) for 5-13-years children with cerebral palsy to assess participation will fill at pre and post session by parents.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 8 and 12 years of age at the time of intake; diagnosis of cerebral palsy that is determined by neurologist; level 1, 2, or 3 on the Gross Motor Function Classification Scale (GMFCS); level 1, 2 or 3 on The Manual Ability Classification System (MACS); normal intelligence that is determined by Raven test; normal or corrected to normal, hearing and vision; sufficient language ability to communicate with and beunderstood during treatment. Exclusion criteria: dissuasion of parents in making response to questions of measurements or bringing students to the intervention sessions; dissuasion of students in making response to questions of measurements or coming to the intervention sessions; child had previously received, or were presently receiving, a cognitive treatment.
Intervention groups
Cognitive orientation to daily occupational performance (CO-OP): is a well-explicated top-down, problem solving approach that has been shown to support skill acquisition and a client-centered approach. The CO-OP approach differ from traditional bottom-up interventions in that it is situated in a learning paradigm and use cognitive strategies to facilitate skill acquisition at the ICF activity rather than structure and function level, and draw on motor learning principle to help children discover how to perform everyday activities. The main objective of CO-OP are skill acquisition, the learning of global problem solving strategy (goal, plan, do, check) and the identification of domain-specific strategies to support generalization to the other environment and transfer to other motor-based tasks. CO-OP can be used to enable the achievement of occupation-based goal while simultaneously promoting self-efficacy. “9 child with inclusion criteria will enter to CO-OP group., Each sample will receive the intervention two days a week and 2 hours in every day. Each sample will receive 12 hours treatment. Current approach for children with cerebral palsy: this treatment typically focus on remediation or bottom-up approaches. Many of this therapeutic approaches to managing cerebral palsy are based on neuromaturational models of motor development which focus on improving motor movement (bottom-up approaches) and do not emphasize performance in every day activities. Other approaches implementing these bottom-up strategies, such as casting and positioning techniques, can be effective in achieving in anatomical goals such as increase range of motion and enhancing postural tone. Little evidence exists that achieving these anatomical goals translates into improved task performance or motor-based skill acquisition among children with cp.
Main outcome variables
Participation; Mastery motivation; Volition; Motivation during therapy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120910010806N5
Registration date: 2018-02-14, 1396/11/25
Registration timing: registered_while_recruiting

Last update: 2018-02-14, 1396/11/25
Update count: 1
Registration date
2018-02-14, 1396/11/25
Registrant information
Name
Malahat Akbarfahimi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
akbarfahimi.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-12, 1396/11/23
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of “Cognitive Orientation to daily Occupational Performance (CO-OP)” with Current Treatment Approach (CTA) on motivation and participation of 8-12 years old children with cerebral palsy
Public title
The effect of “Cognitive Orientation to daily Occupational Performance (CO-OP)” on motivation and participation of 8-12 years old children with cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 8 and 12 years at the time of sampling Diagnosis of cerebral palsy that is determined by a neurologist Level 1, 2, or 3 on the Gross Motor Function Classification Scale (GMFCS) Level 1,2 or 3 on The Manual Ability Classification System (MACS) Normal intelligence Normal or near to normal in hearing and vision Sufficient language ability to communicate with the therapist and be understood during treatment
Exclusion criteria:
Dissuasion of parents in making response to questions of measurements or bringing students to the intervention sessions Dissuasion of students in making response to questions of measurements or coming to the intervention sessions Child had previously received, or is presently receiving, a cognitive treatment
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 9
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will select by covenience sampling. Randomizing participants in CO-OP & CTA groups will done with randomization digits table by a blind person to the study.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants will not aware of the group that are randomized. In this study the assesments will performed by parent, the child and trained assessor who are blind to the study. The data will enter in SPSS and statistically analysis by a blind statistician.
Placebo
Not used
Assignment
Parallel
Other design features
Cognitive Orientation to Daily Occupational Performance (CO-OP): is a well-explicated top-down, problem solving approach that has been shown to support skill acquisition and a client-centered approach. The CO-OP approach differ from traditional bottom-up interventions in that it is situated in a learning paradigm and use cognitive strategies to facilitate skill acquisition at the ICF activity rather than structure and function level, and draw on motor learning principle to help children discover how to perform everyday activities. The main objective of CO-OP are skill acquisition, the learning of global problem solving strategy (goal, plan, do, check) and the identification of domain-specific strategies to support generalization to the other environment and transfer to other motor-based tasks. CO-OP can be used to enable the achievement of occupation-based goal while simultaneously promoting self-efficacy. “9 child with inclusion criteria will enter to CO-OP group., Each sample will receive the intervention two days a week and 2 hours in every day. Each sample will receive 12 hours treatment. Current Treatment Approach(CTA) for children with cerebral palsy: this treatment typically focus on remediation or bottom-up approaches. Many of this therapeutic approaches to managing cerebral palsy are based on neuromaturational models of motor development which focus on improving motor movement (bottom-up approaches) and do not emphasize performance in every day activities. Other approaches implementing these bottom-up strategies, such as casting and positioning techniques, can be effective in achieving in anatomical goals such as increase range of motion and enhancing postural tone. Little evidence exists that achieving these anatomical goals translates into improved task performance or motor-based skill acquisition among children with cp.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی و خدمات درمانی ایران
Street address
iran univercity of medical science- shahid Hemmat highway- Tehran- Iran
City
tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-01-18, 1396/10/28
Ethics committee reference number
IR.IUMS.REC1396.9511355001

Health conditions studied

1

Description of health condition studied
Cerebral Palsy (CP)
ICD-10 code
G80-G83
ICD-10 code description
Cerebral palsy and other paralytic syndromes

Primary outcomes

1

Description
participation
Timepoint
pre and post treatment
Method of measurement
Life habit questionnaire(LIFE_H) for 5-13 years children with cerebral palsy

2

Description
Motivation during therapy
Timepoint
sessions 1, 3,7,11 and 12
Method of measurement
The Pediatric motivation scale for children rehabilitation

3

Description
Mastery motivation
Timepoint
Pre and post treatment + session 6
Method of measurement
Dimensions of mastery questionnaire (DMQ) The DMQparent proxy-report

4

Description
Volition
Timepoint
Pre and post treatment + session 6
Method of measurement
Pediatric volitional questionnaire (PVQ)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Cognitive orientation to daily occupational performance (CO-OP): is a well-explicated top-down, problem solving approach that has been shown to support skill acquisition and a client-centered approach. The CO-OP approach differ from traditional bottom-up interventions in that it is situated in a learning paradigm and use cognitive strategies to facilitate skill acquisition at the ICF activity rather than structure and function level, and draw on motor learning principle to help children discover how to perform everyday activities. The main objective of CO-OP are skill acquisition, the learning of global problem solving strategy (goal, plan, do, check) and the identification of domain-specific strategies to support generalization to the other environment and transfer to other motor-based tasks. CO-OP can be used to enable the achievement of occupation-based goal while simultaneously promoting self-efficacy. in this study participant will choose three treatment goals by use of Candian Occupational Performance Model (COPM). Primary sessions of CO-OP include to review the child's "daily activity log", setting goals and teaching general strategies. Middle sessions include facilitating the learning and use of domain specific strategy and family education . In the final sessions, the suppportive role of therapist is reduced and the child is prepared for the transfer of general and specific strategies to other tasks.
Category
Rehabilitation

2

Description
Control group: Current treatment approach (CTA)Current approach for children with cerebral palsy: this treatment typically focus on remediation or bottom-up approaches. Many of this therapeutic approaches to managing cerebral palsy are based on neuromaturational models of motor development which focus on improving motor movement (bottom-up approaches) and do not emphasize performance in every day activities. Other approaches implementing these bottom-up strategies, such as casting and positioning techniques, can be effective in achieving in anatomical goals such as increase range of motion and enhancing postural tone. Little evidence exists that achieving these anatomical goals translates into improved task performance or motor-based skill acquisition among children with cp. 9 children between age 8-12 will receive twelve 45-minute sessions of intervention on average twice per week.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
sourosh school (for physical disabilities)
Full name of responsible person
Mr saeid reisi
Street address
9th Boostan ave / Pasdaran Blv
City
tehran
Province
Tehran
Postal code
1666643134
Phone
+98 21 2257 5566
Email
saeedreese1@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. malahat akbarfahimi
Street address
Occupational Therapy department- School of Rehabilitation Sciences- Madadkaran alley- Shah-Nazari street- Madar square- Mirdamad avenue
City
tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
akbarfahimi.m@iums.ac.ir
Grant name
Research deputy of Iran university of medical sciences
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
zahra poorzamani dehkordi
Position
master candidate of Occupational Therapy
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Occupational Therapy department- School of Rehabilitation Sciences- Madadkaran alley- Shah-Nazari street- Madar square- Mirdamad avenue
City
tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 2059
Email
poorzamani_zp@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
dr malahat akbarfahimi
Position
PhD in neuroscience- Faculty of Iran Univercity of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Occupational Therapy department- School of Rehabilitation Sciences- Madadkaran alley- Shah-Nazari street- Madar square- Mirdamad avenue
City
tehran
Province
Tehran
Postal code
1545913478
Phone
+98 21 2222 2059
Email
akbarfahimi.m@iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
zahra poorzamani dehkordi
Position
master candidate of Occupational Therapy
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
Occupational Therapy department- School of Rehabilitation Sciences- Madadkaran alley- Shah-Nazari street- Madar square- Mirdamad avenue
City
tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
poorzamani_zp@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is 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
Article puplished
When the data will become available and for how long
March 2019
To whom data/document is available
The researcher and occupational therapists
Under which criteria data/document could be used
Other research, critics, check and clinical usage
From where data/document is obtainable
First person in article
What processes are involved for a request to access data/document
Send request by email
Comments
Loading...