Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000120471
Ethics application status
Approved
Date submitted
20/10/2006
Date registered
9/02/2007
Date last updated
1/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Home Program Effectiveness
Scientific title
Effectiveness of Occupational Therapy Home Program Intervention for Children with Cerebral Palsy in Reaching Family Goals: A Double Blinded Randomised Controlled Trial
Secondary ID [1] 288908 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 1612 0
Condition category
Condition code
Neurological 1719 1719 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 1720 1720 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individualised occupational therapy home programs. Participants are randomised to 2intervention groups. Group 1 receives a home program for 8 weeks. Group 2 receives a home program for 4 weeks. A home program is a list of suggested exercises, environmental modifications and parent teaching strategies provided to the family as a treatment plan aimed at reaching the parent's goals for thier child's health. The parent can self-select how long they carry out the home program for and record this on a log book provided by the investigator. Ealier research shows that families typically choose between 5-40 minutes per day, with a mean of 13 minutes (Novak, Cusick & Lowe, 2005).
Intervention code [1] 1416 0
Rehabilitation
Comparator / control treatment
Group 3 is a control group and does not receive any intervention. They will be provided with a home program at the end of the 8 weeks of 'control period' so as to maintain their blinded allocation.
Control group
Placebo

Outcomes
Primary outcome [1] 2388 0
Performance and satisifaction scores on the Canadian Occuptional Performance Measure
Timepoint [1] 2388 0
Baseline, 4 weeks and 8 weeks
Secondary outcome [1] 4151 0
Goal achievement as measured on the Goal Attainment Scale
Timepoint [1] 4151 0
Baseline, 4 weeks, and 8 Weeks
Secondary outcome [2] 4152 0
Participation as measured on the Children's Assessment of Participation and Enjoyment
Timepoint [2] 4152 0
Baseline, 4 weeks, and 8 Weeks
Secondary outcome [3] 4153 0
Upper limb quality of movement as measured on the Quality of Upper Extremity SKills Test.
Timepoint [3] 4153 0
Baseline, 4 weeks, and 8 Weeks

Eligibility
Key inclusion criteria
1. Children with cerebral palsy, who are attending school from Kindergarten to Year Six, i.e. infants and primary school age. 2. Consent to participate given by parent or ‘person responsible’Child is on a waiting list for occupational therapy at The Spastic Centre of NSW, not involved in active therapy provision. 3. At time of study enrolment, the child is not currently receiving occupational therapy from any other service provider 4. Children who have greater than 4-week wait until they will receive an occupational therapy service from The Spastic Centre of NSW6. Children where the parent has some concern about the child’s arm use.
Minimum age
5 Months
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Consent not given by parent or ‘person responsible’2. Children waiting for Spastic Centre occupational therapy services that do not require or request an intervention program but rather require solely professional documentation or specialist equipment prescription, such as: letter of support for teaching assistant time in the classroom; letter of support for adaptive equipment funding; prescription of a new wheelchair or assistive technology3. Children who are receiving regular occupational therapy services from another service provider whilst they are on The Spastic Centre of NSW waiting list.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation (sequence generation) using block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The Participants are blind and the evaluators are blind
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/10/2006
Actual
8/02/2007
Date of last participant enrolment
Anticipated
Actual
24/07/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 1867 0
Other
Name [1] 1867 0
Cerebral Palsy Institute
Country [1] 1867 0
Australia
Primary sponsor type
Other
Name
Cerebral Palsy Institute
Address
Sydney NSW
Country
Australia
Secondary sponsor category [1] 1684 0
None
Name [1] 1684 0
N/A
Address [1] 1684 0
N/A
Country [1] 1684 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3476 0
The Spastic Centre HREC-University of Western Sydney
Ethics committee address [1] 3476 0
Ethics committee country [1] 3476 0
Australia
Date submitted for ethics approval [1] 3476 0
Approval date [1] 3476 0
15/03/2006
Ethics approval number [1] 3476 0
EC00402

Summary
Brief summary
Children with cerebral palsy benefit from therapy that is goal-directed in their daily activities and environment. It is hypothesised that their parent’s contribution via home exercise programming is also important for goal achievement. This hypothesis has not been tested in a randomised controlled trial, the appropriate research design for studying intervention effectiveness. Benefits of home programs have been shown in my earlier Masters pilot study, which lacked a controlled comparison group. When measuring children, any improvements observed may be due to maturation and therefore a control group is the preferable design. This study will address this gap
Trial website
Trial related presentations / publications
Novak, I., Cusick, A & Lannin, N. (2009). "Occupational Therapy Home Programs for Cerebral Palsy: Double-Blind, Randomized, Controlled Trial", Pediatrics, 124(4), e606-e614
Public notes

Contacts
Principal investigator
Name 27350 0
Prof Iona Novak
Address 27350 0
Cerebral Palsy Alliance
PO Box 6427 Frenchs Forest 2086
NSW
Country 27350 0
Australia
Phone 27350 0
0409078917
Fax 27350 0
Email 27350 0
[email protected]
Contact person for public queries
Name 10605 0
Prof Iona Novak
Address 10605 0
Cerebral Palsy Alliance
PO Box 6427 Frenchs Forest 2086
NSW
Country 10605 0
Australia
Phone 10605 0
0409078917
Fax 10605 0
Email 10605 0
[email protected]
Contact person for scientific queries
Name 1533 0
Prof Iona Novak
Address 1533 0
Cerebral Palsy Alliance
PO Box 6427 Frenchs Forest 2086
NSW
Country 1533 0
Australia
Phone 1533 0
+61409078917
Fax 1533 0
Email 1533 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.