Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000749606
Ethics application status
Approved
Date submitted
17/10/2005
Date registered
17/11/2005
Date last updated
17/11/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Motor Skills Project
Scientific title
The effect of a motor skills training program for children with physical diabilities on motor skills acquisition and self perception
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children with physical disabilities - cerebral palsy 901 0
Down's syndrome 902 0
Spina bifida 903 0
Condition category
Condition code
Neurological 969 969 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 970 970 0 0
Down's syndrome

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children will be randomised into one of two groups:
Group A: Weekly occupational therapy for 6 weeks followed by weekly physiotherapy for a further 6 weeks.
Group B: Twice weekly physiotherapy for 6 weeks followed by twice weekly occupational therapy for 6 weeks.

Occupational therapy will consist of upper limb dexterity training
Physiotherapy will consist of lower limb strength and endurance training
Intervention code [1] 721 0
Treatment: Other
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1289 0
Change in Self Perception
Timepoint [1] 1289 0
Measures will be taken at baseline, at 6 weeks, at 12 weeks and one and three months post completion of both physiotherapy and occupational therpay programs
Primary outcome [2] 1290 0
Change in motor skills acquisition
Timepoint [2] 1290 0
Measures will be taken at baseline, at 6 weeks, at 12 weeks and one and three months post completion of both physiotherapy and occupational therpay programs
Secondary outcome [1] 2317 0
A questionnaire will be distributed upon completion of the occupational therapy program and the physiotherapy program. This will be used to elicit the parents and children's perceptions in participating in the program.
Timepoint [1] 2317 0

Eligibility
Key inclusion criteria
Children attending state schools, children that have applied for but not assessed as eligible for the program for students with disabilities (PSD), children with a movement disorder such as cerebral palsy, spina bifida, Down's Syndrome and acquired brain injury, Rating on Functional Mobility Scale of four, five or six when ambulating minimum of 50m.
Minimum age
6 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children who have not applied to the PSD, Children who are receiving assistance under the PSD, Rating on Functional Mobility Scale of 3 or less when ambulating a minimum of 50m.

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 will be used
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random numbers table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1067 0
Charities/Societies/Foundations
Name [1] 1067 0
Australian Physiotherapy Association
Country [1] 1067 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Physiotherapy Association
Address
Country
Australia
Secondary sponsor category [1] 929 0
None
Name [1] 929 0
None
Address [1] 929 0
Country [1] 929 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36392 0
Address 36392 0
Country 36392 0
Phone 36392 0
Fax 36392 0
Email 36392 0
Contact person for public queries
Name 9910 0
Michelle Vu
Address 9910 0
Australian Physiotherapy Association
PO Box 6465
St Kilda Rd Central
St Kilda VIC 8008
Country 9910 0
Australia
Phone 9910 0
+61 3 95349400
Fax 9910 0
+61 3 95349199
Email 9910 0
[email protected]
Contact person for scientific queries
Name 838 0
Michelle Vu
Address 838 0
Australian Physiotherapy Association
PO Box 6465
St Kilda Rd Central
St Kilda VIC 8008
Country 838 0
Australia
Phone 838 0
+61 3 95349400
Fax 838 0
+61 3 95349199
Email 838 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.