Cerebral PalsyNCT00430131
Investigating Best Practices for Children With Cerebral Palsy: A Pilot Study of Two Approaches
A study testing Cognitive Orientation to Occupational Performance and Contemporary Treatment Approach in people with Cerebral Palsy, run by University of Toronto.
Trial summary
This project (CO-OP II) is the second in a series of three studies to validate a new treatment approach for children with cerebral palsy (CP). The initial study was comprised of a series of four single case studies with children with CP. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Cognitive Orientation to Occupational Performance and Contemporary Treatment Approach
- Type of treatment
- Surgery or procedure
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Sep 2009
- 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 7 to 12 years
- All sexes
- Child
Who may be able to join
- between 7 and 12 years of age
- diagnosis of cerebral palsy with hemiplegia or spastic diplegia
- Level 1,2 or 3 on the Gross Motor Function Classification Scale(GMFCS)
- normal intelligence (IQ> 85 on at least one scale (verbal or performance) of the Kaufman Brief Intelligence Test (KBIT-2)
- child assent and agreement to participate
- parental consent and agreement to participate
- sufficient language ability to communicate with and be understood during treatment
Who cannot join
- previously received or presently receiving a cognitive treatment for motor-based performance problems
- use of alternative communication system such as PECS or communication board
- regular use of BOTOX during intervention period
About this study
This project (CO-OP II) is the second in a series of three studies to validate a new treatment approach for children with cerebral palsy (CP). The initial study was comprised of a series of four single case studies with children with CP. It evaluated the potential of the Cognitive Orientation to Occupational Performance (CO-OP) approach to be used with children with CP and tested the procedures for CO-OP II. The overall objective of the full series of studies is to determine whether better functional outcomes are achieved for children with CP with CO-OP intervention than with contemporary occupational therapy treatment.
The primary objective of CO-OP II is to establish the feasibility of conducting a full scale randomize control trial (RCT) to discover if there are differences in functional outcomes (i.e., improvement in task performance, self efficacy) between a group of children with CP receiving CO-OP therapy and a group receiving a contemporary treatment approach (CTA). In order to meet this objective, a pilot RCT will be conducted to answer the specific research questions outlined below:
Read more
- Do children wiht CP acquire the skills they set as goals in each of the two treatment groups?
- Do the acquired skills generalize and transfer?
- Are the skills maintained at 4 months post intervention?
- Does the CO-OP approach produce a larger effect on skill acquisition and self efficacy than the CTA?
- Does amount of parent involvement have any effect on skill acquisition or self efficacy?
Completion of this pilot RCT will provide the necessary data to conduct a full study to test the following hypothesis:
- Children with CP who receive CO-OP treatment will be more successful than children receiving CTA in improving their performance on child-chosen skills and they self efficacy.
- Conditions
- Cerebral Palsy
- Being tested
- Cognitive Orientation to Occupational Performance, Contemporary Treatment Approach
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Orientation to Occupational PerformanceProcedure or surgery
Contemporary Treatment ApproachProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startDec 2006
- Study completionSep 2009 (estimated)
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 University of TorontoThe 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
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Holland Bloorview Kids Rehabilitation Hospital, ErinoakKids
- Investigators
- Debra L Cameron, PhD. O.T., Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430131
- Sponsor's protocol ID
- BKR-06-055
- Status last verified
- Aug 2009
- First submitted
- 30 Jan 2007
- Last updated
- 13 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Best Practices for Children With Cerebral Palsy: A Pilot Study of Two Approaches
- ClinicalTrials.gov ID
- NCT00430131
- Acronym / sponsor ID
- BKR-06-055
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Holland Bloorview Kids Rehabilitation Hospital, ErinoakKids
- Study start
- Dec 2006
- Study completion
- Sep 2009 (estimated)
- First posted
- 1 Feb 2007 (estimated)
- 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 project (CO-OP II) is the second in a series of three studies to validate a new treatment approach for children with cerebral palsy (CP). The initial study was comprised of a series of four single case studies with children with CP. It evaluated the potential of the Cognitive Orientation to Occupational Performance (CO-OP) approach to be used with children with CP and tested the procedures for CO-OP II. The overall objective of the full series of studies is to determine whether better functional outcomes are achieved for children with CP with CO-OP intervention than with contemporary occupational therapy treatment.
The primary objective of CO-OP II is to establish the feasibility of conducting a full scale randomize control trial (RCT) to discover if there are differences in functional outcomes (i.e., improvement in task performance, self efficacy) between a group of children with CP receiving CO-OP therapy and a group receiving a contemporary treatment approach (CTA). In order to meet this objective, a pilot RCT will be conducted to answer the specific research questions outlined below:
- Do children wiht CP acquire the skills they set as goals in each of the two treatment groups?
- Do the acquired skills generalize and transfer?
- Are the skills maintained at 4 months post intervention?
- Does the CO-OP approach produce a larger effect on skill acquisition and self efficacy than the CTA?
- Does amount of parent involvement have any effect on skill acquisition or self efficacy?
Completion of this pilot RCT will provide the necessary data to conduct a full study to test the following hypothesis:
- Children with CP who receive CO-OP treatment will be more successful than children receiving CTA in improving their performance on child-chosen skills and they self efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (7 listed)
- between 7 and 12 years of age
- diagnosis of cerebral palsy with hemiplegia or spastic diplegia
- Level 1,2 or 3 on the Gross Motor Function Classification Scale(GMFCS)
- normal intelligence (IQ> 85 on at least one scale (verbal or performance) of the Kaufman Brief Intelligence Test (KBIT-2)
- child assent and agreement to participate
Key exclusion criteria (3 listed)
- previously received or presently receiving a cognitive treatment for motor-based performance problems
- use of alternative communication system such as PECS or communication board
- regular use of BOTOX during intervention period
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 |
|---|---|---|
| Cognitive Orientation to Occupational Performance | Procedure or surgery | – |
| Contemporary Treatment Approach | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2009.
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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.
Debra L Cameron, PhD. O.T. principal investigator
University of Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Orientation to Occupational Performance and Contemporary Treatment Approach in people with Cerebral Palsy, run by University of Toronto.
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 7 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: status not confirmed, as of the sponsor's last update on 13 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
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 13 Aug 2009.