Cerebral PalsyNCT06231901
Comparison of CO-OP and GDT on Occupational Performance and Functional Status in the CP
A study testing CO-OP, GDT and traditional occupational therapy in people with Cerebral Palsy and Occupational Problems, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This study was designed as a three-armed, single-blinded, randomized, controlled trial to examine the effectiveness of CO-OP and GDT interventions on occupational performance and functional status in children with CP compared with their usual care. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Cerebral Palsy, Occupational Problems, Cognitive Orientation
- What is being tested?
- CO-OP, GDT and traditional occupational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jan 2024to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- being between 5-10 years of age
- being diagnosed with CP
- having adequate language abilities to make contact with a therapist and be informed during intervention.
Who cannot join
- they were receiving any other treatment
- they had been diagnosed with mental retardation
- they had serious vision or hearing problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach and Goal-Directed Training on Occupational Performance and Functional Status in Children With Cerebral Palsy: A Three-Armed Randomized Controlled Trial
This study was designed as a three-armed, single-blinded, randomized, controlled trial to examine the effectiveness of CO-OP and GDT interventions on occupational performance and functional status in children with CP compared with their usual care.
Read the detailed description
Cerebral palsy (CP) is a group of neurological disorders that affect movement, muscle tone, and posture, causing activity limitations that originated in the developing fetal or infant brain that are attributed to non-progressive disorders. Symptoms such as spasticity and contracture in CP cause a decrease in functional skill level with limitations in daily living activities such as learning a new skill or self-dressing and handwriting. In this disease, the simultaneous presence of sensory, cognitive, perceptual, and behavioral impairments significantly undermines the acquisition and execution of functional skills, autonomy in daily living, and active engagement in leisure activities. This study was planned to investigate and compare the impact of CO-OP and GDT on the occupational performance and functional status of children with CP.
- Conditions
- Cerebral Palsy, Occupational Problems, Cognitive Orientation, Goals
- Being tested
- CO-OP, GDT, traditional occupational therapy
- Keywords
- cerebral palsy, occupational performance, functional status, CO-OP, goal directed training
- Medical subject headings
- Cerebral Palsy, Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO-OPOther
Also called Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach
With a task-specific and goal-focused CO-OP approach; it is aimed to increase one's skills, to teach to use self-generated cognitive strategies, and to encourage generalization and transfer to new situations and activities.
GDTOther
Also called goal directed training
Goal-directed training included the active implementation of task-specific activities related to the child's functional goals. Focusing on motor learning, GDT is an activity-based approach to therapy that uses meaningful, self-selected goals to provide opportunities for problem solving and indirectly guide the movements necessary to successfully meet task demands
traditional occupational therapyOther
The program included functional one-handed and two-handed training and consisted of advice and treatment aimed at reducing spasticity, improving hand function and activities of daily living, and providing appropriate orthoses. It also includes techniques aimed at improving impairment (e.g., stretching, sensory stimulation) and strengthening activities (e.g., motor training, environmental modification, performing specific target activities) to help participants achieve their individual goals.
| Study group | Role | What they receive |
|---|---|---|
| coop plus traditional occupational therapy | Experimental | This group received the traditional occupational therapy plus CO-OP approach. Receives: Other: CO-OP; Other: traditional occupational therapy |
| GDT plus traditional occupational therapy | Experimental | This group received the traditional occupational therapy plus Goal directed training. Receives: Other: GDT; Other: traditional occupational therapy |
| traditional occupational therapy | Other | This group only received the traditional occupational therapy . Receives: Other: traditional occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure (COPM)
COPM is used to help individuals describe occupational performance problems and precedence in the areas of self-care, productivity, and leisure, in which they have difficulty performing.
Measured: "up to 12 weeks"
Pediatric Evaluation of Disability Inventory (PEDI):
PEDI is a measurement tool used to evaluate the functional status of children.
Measured: "up to 12 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start17 Jan 2024
- Primary completion31 Mar 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZEYNEP KOLİT, Hacettepe University
- Investigators
- zeynep kolit, MSc, Principal investigator, Hacettepe UniversityRüya gül temel, MSc, Principal investigator, HATAY MUSTAFA KEMAL ÜNİVERSİTESİGamze ekici, PhD, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231901
- Sponsor's protocol ID
- CG24
- Status last verified
- Apr 2024
- First submitted
- 17 Jan 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach and Goal-Directed Training on Occupational Performance and Functional Status in Children With Cerebral Palsy: A Three-Armed Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06231901
- Acronym / sponsor ID
- CG24
- Conditions
- Cerebral Palsy, Occupational Problems, Cognitive Orientation, Goals
- Keywords
- cerebral palsy, occupational performance, functional status, CO-OP, goal directed training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed as a three-armed, single-blinded, randomized, controlled trial to examine the effectiveness of CO-OP and GDT interventions on occupational performance and functional status in children with CP compared with their usual care.
Detailed description
Cerebral palsy (CP) is a group of neurological disorders that affect movement, muscle tone, and posture, causing activity limitations that originated in the developing fetal or infant brain that are attributed to non-progressive disorders. Symptoms such as spasticity and contracture in CP cause a decrease in functional skill level with limitations in daily living activities such as learning a new skill or self-dressing and handwriting. In this disease, the simultaneous presence of sensory, cognitive, perceptual, and behavioral impairments significantly undermines the acquisition and execution of functional skills, autonomy in daily living, and active engagement in leisure activities. This study was planned to investigate and compare the impact of CO-OP and GDT on the occupational performance and functional status of children with CP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| coop plus traditional occupational therapy | Experimental | Other: CO-OP, Other: traditional occupational therapyThis group received the traditional occupational therapy plus CO-OP approach. |
| GDT plus traditional occupational therapy | Experimental | Other: GDT, Other: traditional occupational therapyThis group received the traditional occupational therapy plus Goal directed training. |
| traditional occupational therapy | Other | Other: traditional occupational therapyThis group only received the traditional occupational therapy . |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- being between 5-10 years of age
- being diagnosed with CP
- having adequate language abilities to make contact with a therapist and be informed during intervention.
Key exclusion criteria (3 listed)
- they were receiving any other treatment
- they had been diagnosed with mental retardation
- they had serious vision or hearing problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO-OPAlso: Cognitive Orientation to Daily Occupational Performance (CO-OP) ApproachWith a task-specific and goal-focused CO-OP approach; it is aimed to increase one's skills, to teach to use self-generated cognitive strategies, and to encourage generalization and transfer to new situations and activities. | Other | coop plus traditional occupational therapy |
| GDTAlso: goal directed trainingGoal-directed training included the active implementation of task-specific activities related to the child's functional goals. Focusing on motor learning, GDT is an activity-based approach to therapy that uses meaningful, self-selected goals to provide opportunities for problem solving and indirectly guide the movements necessary to successfully meet task demands | Other | GDT plus traditional occupational therapy |
| traditional occupational therapyThe program included functional one-handed and two-handed training and consisted of advice and treatment aimed at reducing spasticity, improving hand function and activities of daily living, and providing appropriate orthoses. It also includes techniques aimed at improving impairment (e.g., stretching, sensory stimulation) and strengthening activities (e.g., motor training, environmental modification, performing specific target activities) to help participants achieve their individual goals. | Other | GDT plus traditional occupational therapy, coop plus traditional occupational therapy, traditional occupational therapy |
Primary outcome
Canadian Occupational Performance Measure (COPM)
Time frame: "up to 12 weeks"
COPM is used to help individuals describe occupational performance problems and precedence in the areas of self-care, productivity, and leisure, in which they have difficulty performing.
Pediatric Evaluation of Disability Inventory (PEDI):
Time frame: "up to 12 weeks"
PEDI is a measurement tool used to evaluate the functional status of children.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zeynep kolit, MSc principal investigator
Hacettepe University
Rüya gül temel, MSc principal investigator
HATAY MUSTAFA KEMAL ÜNİVERSİTESİ
Gamze ekici, PhD study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO-OP, GDT and traditional occupational therapy in people with Cerebral Palsy and Occupational Problems, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Canadian Occupational Performance Measure (COPM) (time frame: "up to 12 weeks"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.