Protocol summary
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Study aim
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The comparison of (CO-OP)” with current treatment approach (CTA) on motivation and participation
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Design
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Clinical, Randomized, Tripple-blind trial with two parallel group
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Settings and conduct
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consent form will obtain from parents. children who eligible are randomly assigned to CO-OP and CTA groups. partcipant choose their three treatment goals based on COPM. pediatric volitional questionnaire in children are administered by an unaware therapist through video recording pre/post-test and follow-up. On thePediatric motivation" (PMOT) is completed by the child in sessions 1, 3, 7, 12 during intervention. "Dimensions of mastery questionnaire(DMQ), "Life habit questionnaire" (LIFE_H) GAS and COPM will be filled in pre/post test and follow-up. "
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age 8 and 12 years of age a; diagnosis of cerebral palsy that is determined by neurologist; level 1- 3 on the Gross Motor Function Classification Scale (GMFCS); level 1- 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
Exclusion criteria: dissuasion of parents and child ; child had previously received a cognitive treatment.
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Intervention groups
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CO-OP group: Children choose three goals based on COPM and with the approach of CO-OP", acquire skills, learn general problem-solving strategies (goal, planning, implementation, review and identification of strategies specific to the CO-OP). This study will be presented in 45 to 1 hour sessions twice a week for 12.
CTA : 45- to 1-hour sessions will be offered twice a week for 12 sessions.
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Main outcome variables
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Primary outcomes: Participation, motivation during rehabilitation,Mastery motivation to master, Volition
Secondary Outcomes: Satisfaction and Performance Score of COPM, Goal Attainment Scale(GAS)
General information
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Reason for update
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The results of the pilot study showed that the evaluation of the second stage (sixth session) is indeterminate due to interfere with intervention programs for performing second activity goals (we had three goals, each goal approximately required 4 sessions of intervention, the sixth session is one of the goals in the middle of which the results could not be analyzed) Therefore, the evaluation of the second stage was removed and replaced with a follow-up evaluation two months after the last session.
In order to assess the achievement of children's goals in the study, with a top-down approach and a client-centered approach, the Assessment of Goal Attainment Scale (GAS) and the Canadian occupational Performance Measurement(COPM) were included to the study as secondary outcomes.
The main reasons for not updating on time are: 1- Training of the therapist "Cognitive to daily work performance (CO_OP)" which lasted about four months, 2- The need to run a pilot, the results of which lasted six months, 3- Consequences of the Covid 19 pandemic.4: Edit and summerize the abstract due to word count limitation
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20120910010806N5
Registration date:
2018-02-14, 1396/11/25
Registration timing:
prospective
Last update:
2021-02-24, 1399/12/06
Update count:
1
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Registration date
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2018-02-14, 1396/11/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-02-12, 1396/11/23
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Expected recruitment end date
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2018-06-21, 1397/03/31
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Actual recruitment start date
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2018-12-22, 1397/10/01
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Actual recruitment end date
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2020-01-20, 1398/10/30
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Trial completion date
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2020-01-30, 1398/11/10
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Scientific title
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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
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Public title
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The effect of “Cognitive Orientation to daily Occupational Performance (CO-OP)” on motivation and participation of 8-12 years old children with cerebral palsy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 8 years old to 12 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
9
Actual sample size reached:
9
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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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.
Ethics committees
1
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Ethics committee
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Approval date
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2018-01-18, 1396/10/28
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Ethics committee reference number
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IR.IUMS.REC1396.9511355001
Health conditions studied
1
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Description of health condition studied
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Cerebral Palsy (CP)
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ICD-10 code
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G80
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ICD-10 code description
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Cerebral palsy
Primary outcomes
1
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Description
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participation
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Timepoint
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pretest , post test and follow-up (two months after last session)
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Method of measurement
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Life habit questionnaire(LIFE_H) for 5-13 years children with cerebral palsy
2
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Description
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Motivation during therapy
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Timepoint
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sessions 1, 3,7,11 and 12
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Method of measurement
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The Pediatric motivation scale for children rehabilitation
3
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Description
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Mastery motivation
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Timepoint
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pretest , post test and follow-up (two months after last session)
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Method of measurement
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Dimensions of mastery questionnaire (DMQ) The DMQ parent proxy-report
4
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Description
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Volition
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Timepoint
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pretest , post test and follow-up (two months after last session)
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Method of measurement
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Pediatric volitional questionnaire (PVQ)
Secondary outcomes
1
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Description
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Goal achievement
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Timepoint
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Pretest, post test and follow-up
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Method of measurement
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Goal Attainment scale (GAS)
2
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Description
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Performance and satisfaction scores of child-chosen goal
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Timepoint
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Pretest, post test and follow-up
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Method of measurement
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Canadian Occupational Performance Measurement (COPM)
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Research deputy of Iran university of medical sciences
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Article puplished
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When the data will become available and for how long
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March 2019
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To whom data/document is available
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The researcher and occupational therapists
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Under which criteria data/document could be used
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Other research, critics, check and clinical usage
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From where data/document is obtainable
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First person in article
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What processes are involved for a request to access data/document
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Send request by email
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Comments
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