Protocol summary
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Study aim
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The Adaptation of Cognitive Orientation to daily Occupational Performance (CO-OP) approach by adding self-controlled video feedback and investigating its effect on the upper limb Occupational Performance of children with spastic cerebral palsy
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Design
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This is a randomized controlled trial with blinded assessors and is a superiority trial. 39 participants in this study will be assigned to one of three groups after stratified block randomization: control group, CO-OP approach, and adapted CO-OP approach.
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Settings and conduct
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Interventions will be carried out in governmental and non-governmental occupational therapy clinics and exceptional schools in Zanjan. All assessments will be conducted by an occupational therapist and blinded to the allocation of participants.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Diagnosis of spastic cerebral palsy by a neurologist
Age range between 8 and 11 years
A level 3-1 on the GMFCS, MACS, BFMF, VFCS, CFCS
Achieving an age-appropriate educational level or a score above 70 on the Sparkle Intelligence Estimation Scale
Exclusion criteria
History of orthopedic-reconstructive surgeries within the past six months
History of Botox injections within the past three months
Hearing impairments that cannot be corrected with assistive devices.
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Intervention groups
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Control group: conventional occupational therapy treatments (such as various techniques such as Neurodevelopmental treatment, positioning, etc.).
Interventions Group One: Occupational therapy Cognitive Orientation to daily Occupational Performance Approach
Interventions Group Two: Occupational therapy with an adapted Cognitive Orientation to daily Occupational Performance Approach
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Main outcome variables
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Canadian Occupational Performance Measure
Performance Quality Rating Scale Operational definition
Goal Attainment Scaling
Box and Block Test
ABILHAND-Kids
Pediatric Motivation Scale
General information
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Reason for update
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The location of sample collection has been changed from Tehran to Zanjan. Other details of the study remain unchanged.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20241123063805N1
Registration date:
2024-12-08, 1403/09/18
Registration timing:
prospective
Last update:
2025-10-07, 1404/07/15
Update count:
1
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Registration date
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2024-12-08, 1403/09/18
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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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2025-01-20, 1403/11/01
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Expected recruitment end date
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2026-05-21, 1405/02/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of adapted Cognitive Orientation to daily Occupational Performance (CO-OP) approach by adding self-controlled video feedback on the upper limb Occupational Performance of children with spastic cerebral palsy
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Public title
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Effect of adapted Cognitive Orientation to daily Occupational Performance approach on spastic cerebral palsy children
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diagnosis of spastic cerebral palsy by a neurologist
The age range is between 8 and 11 years
level 1-3 of gross motor function based on GMFCS scale
level 1-3 of hand function based on MACS scale
level of 1-3 of bimanual fine motor function on BFMF scale
level of 1-3 of visual function on the VFCS scale
level of 1-3 of verbal communication ability using Persian language based on the CFCS scale
Placement in the education level according to age or a score higher than 70 based on Sparkle's IQ estimation criteria
Exclusion criteria:
History of orthopedic-reconstructive surgeries within the past six months
History of botox injection during the last three months
Hearing impairments that cannot be corrected with the use of assistive devices.
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Age
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From 8 years old to 11 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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Sample size
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Target sample size:
39
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Considering that Manual Ability Classification System (MACS) levels one to three have been determined as the criteria for entering the research, and on the other hand, it is the main dependent variable of studying the occupational performance of the upper limb therefore for the random allocation of samples, stratified block randomization method will be used. (MACS 1), (MACS 2) and (MACS 3) are considered as randomization layers. In this regard, a random sequence will be created using blocks of 6 (proportion of sample sizes in three groups during the sampling period) and the online program randomization.com. In fact, for each class, there is a specific blocked sequence in which the samples are entered into the desired sequence after evaluation according to the MACS level. To conceal the random sequence, the SNSOE method (Sequentially Numbered, Selected, Opaque Envelops ) will be used, and in the implementation, the person who creates the random sequence process is separate from the person who assigns the participants to the groups.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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All assessments (primary, secondary, and follow-up) in all three intervention groups (intervention one, intervention two, and control group) will be conducted by an experienced and trained occupational therapist (with at least three years of clinical experience in children) outside the research group and blinded to the allocation of participants to the control and intervention groups (intervention one and two).
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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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Ethics committees
1
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Ethics committee
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Approval date
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2024-11-09, 1403/08/19
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Ethics committee reference number
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IR.IUMS.REC.1403.682
Health conditions studied
1
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Description of health condition studied
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Cerebral palsy
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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
2
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Description of health condition studied
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Spastic diplegic cerebral palsy
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ICD-10 code
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G80.1
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ICD-10 code description
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Spastic diplegic cerebral palsy
3
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Description of health condition studied
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Spastic quadriplegic cerebral palsy
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ICD-10 code
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G80.0
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ICD-10 code description
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Spastic quadriplegic cerebral palsy
4
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Description of health condition studied
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Spastic hemiplegic cerebral palsy
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ICD-10 code
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G80.2
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ICD-10 code description
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Spastic hemiplegic cerebral palsy
Primary outcomes
1
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Description
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Occupational performance, which is the score that participants report on the performance and satisfaction of their chosen occupations based on a semi-structured interview based on the Canadian Occupational Performance Measure.
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Timepoint
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Occupational performance will be assessed at the beginning of the study (before the start of the interventions), after the end of the intervention sessions, and in order to assess the follow-up period six weeks after the end of the interventions.
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Method of measurement
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Canadian Occupational Performance Measure
2
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Description
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The actual performance of the selected occupations is determined from the score that participants obtain from a video-based observational tool called the Performance Quality Rating Scale (operational definition), which is intended to measure the actual performance of the selected activities of the subjects.
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Timepoint
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The actual performance of the selected occupations will be assessed at the beginning of the study (before the start of the interventions), after the end of the intervention sessions, and in order to assess the follow-up period six weeks after the end of the interventions.
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Method of measurement
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Performance Quality Rating Scale (Operational Definition)
3
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Description
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Goal attainment is a method of assessing progress toward individual goals that is used in occupational therapy, physiotherapy, and speech therapy across a wide range of clinical populations, including children, adults, and the elderly.
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Timepoint
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Goal attainment will be assessed at the beginning of the study (before the start of the interventions), after the end of the intervention sessions, and in order to assess the follow-up period six weeks after the end of the interventions.
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Method of measurement
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Goal Attainment Scaling
Secondary outcomes
1
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Description
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Manual ability
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Timepoint
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Manual ability will be assessed at the beginning of the study (before the start of the interventions), after the end of the intervention sessions, and in order to assess the follow-up period six weeks after the end of the interventions.
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Method of measurement
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ABILHAND-Kids
2
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Description
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Gross manual dexterity
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Timepoint
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Gross manual dexterity will be assessed at the beginning of the study (before the start of the interventions), after the end of the intervention sessions, and in order to assess the follow-up period six weeks after the end of the interventions.
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Method of measurement
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Box and Block Test
3
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Description
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Pediatric Motivation
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Timepoint
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To measure changes in motivation during the implementation of interventions, the test was repeated in sequence every three sessions (first, fourth, seventh, and tenth sessions).
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Method of measurement
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Pediatric Motivation Scale
Intervention groups
1
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Description
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Control group: Conventional occupational therapy treatments (such as a variety of techniques such as Neurodevelopmental treatment, positioning, etc.). Therefore, these children were exposed to a broad range of intervention modalities. Intervention techniques included those aimed at improving impairment (eg, stretching) and enhancing activities (eg, motor learning exercises). In control group, as in the other two groups, the child sets four goals using the Canadian Occupational Performance Measure and work on the set treatment goals continues based on the clinical reasoning of the control group therapist who has no training in Cognitive Orientation to Daily Occupational Performance. The number and duration of conventional occupational therapy sessions in the control group will include at least 2 sessions per week for at least 45 minutes. Treatment in the control group will be provided by occupational therapists with at least two years of clinical experience in the field of children with cerebral palsy and outside the research group and will not be aware of the allocation of samples to the control and intervention groups.
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Category
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Rehabilitation
2
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Description
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Intervention group: Occupational therapy with Cognitive Orientation to daily Occupational Performance (CO-OP) Approach. According to the established format, (CO-OP) will be conducted in a clinic setting over eleven sessions (one preparatory session followed by ten therapy sessions), twice a week (each session 45 minutes). In the initial introductory session, the therapist will introduce the child to the global problem-solving strategy (goal-plan-do-check), which will be used when working to achieve the goals. Therefore, in the interventions of this group, each child will be taught a Global Cognitive Strategy, and then the therapist will guide to discover Domain Specific Strategies (DSSs) to improve motor-based occupational performance problems. The therapist will guide the child in discovering his/her plan for functioning, and the child will implement this plan and then check whether the action taken is effective or needs to be modified. Intervention will be done on a single goal first (the goal selected by the child as the first priority during the goal-setting phase), and then second and third goals will be gradually added. The interventions in this group will be conducted by an occupational therapist experienced in using CO-OP in the treatment of children with cerebral palsy.
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Category
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Rehabilitation
3
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Description
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Intervention group: Occupational therapy with an adapted Cognitive Orientation to daily Occupational Performance (CO-OP) Approach. After preparing an adapted version of the (CO-OP) Approach with the addition of self-controlled video feedback, in the preparation session of this group, in addition to explanations about the (CO-OP) approach and the strategies used, necessary training will be provided on how to use self-controlled video feedback. The training provided will be about the importance of benefiting from video feedback and its impact on performance, determining the appropriate time to receive video feedback, how to work with the user interface and manage images, and giving real and practical examples in the form of a case study, and finally the participant will practice how to use it in practice. In the preparation session and before each session, the therapist will remind the participant that at least two or more times should be used self-controlled video feedback and naturally, determining its time, sequence, and number is up to the participant. In fact, participants in this group are able to use elf-controlled video feedback to obtain appropriate cognitive solutions to solve upper limb occupational performance problems. The number of times self-controlled video feedback is received during the sessions will be recorded by the intervention provider. The interventions of this group will be conducted by the main researcher.
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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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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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be 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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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.
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When the data will become available and for how long
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.
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To whom data/document is available
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.
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Under which criteria data/document could be used
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From where data/document is obtainable
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What processes are involved for a request to access data/document
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Comments
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