ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12607000119493

Ethics application status

Approved

Date submitted

20/10/2006

Date registered

9/02/2007

Date last updated

22/04/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Therapy Intensity after BOTOX®

Scientific title

Comparing of Three Different Physiotherapy and Occupational Therapy Intensities Post Botulinum Toxin Injections for Children with Cerebral Palsy for Achieving Family Goal Outcomes

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cerebral Palsy

Condition category

Condition code

Neurological

Other neurological disorders

Physical Medicine / Rehabilitation

Physiotherapy

Physical Medicine / Rehabilitation

Occupational therapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Physiotherapy and Occupational Therapy. Group 1 will receive intense hands-on therapy 3 times per week for 4 weeks, then take a 4 week break with no therapy then repeat the 4 weeks intense therapy 3 times per week (12 weeks duration). Group 2 will receive regular therapy, 1 times per week for 4 weeks, then fortnightly for 4 weeks, then monthly (12 weeks duration). Group 3 will receive a individualised home program with 2 support appointments to be carried out for 12 weeks duration.

Intervention code [1]

Rehabilitation

Comparator / control treatment

As above

Control group

Active

Outcomes

Primary outcome [1]

Performance and Satisfaction scores as measured on the Canadian Occupational Performance Measure.

Timepoint [1]

Baseline, 4, 8, 12, 16 weeks

Secondary outcome [1]

Goal achievement T-Score as measured on the Goal Attainment Scale.

Timepoint [1]

Baseline, 4, 8, 12, 16 weeks

Eligibility

Key inclusion criteria

1. Diagnosis of cerebral palsy 2. Have received BOTOX® in the last 4 weeks from one of the children’s hospitals 3. Eligible for services from The Spastic Centre 4. Functional ability to use the affected limb/s for at least assisted ambulation, or attempts to grip a palm sized toy on request OR of BOTOX® was given for reduction of caregiver burden 5. Informed consent is given.

Minimum age

2 Years

Maximum age

18 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1. Diagnosis is not cerebral palsy2. Botulinum toxin is injected greater than 4 weeks prior to enrollment3. Consent is not given4. Client is not eligible for standard therapy services from The Spastic Centre of NSW.

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 and evaluators are blinded

Phase

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Stopped early

Data analysis

Reason for early stopping/withdrawal

Date of first participant enrolment

Anticipated

15/05/2006

Actual

16/05/2006

Date of last participant enrolment

Anticipated

Actual

18/02/2008

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Other

Name [1]

Cerebral Palsy Institute

Address [1]

PO Box 184
Brookvale NSW 2100

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

The Spastic Centre of NSW, Sydney

Address

PO Box 6427
Frenchs Forest
NSW 2086

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Spastic Centre HREC

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

15/03/2006

Ethics approval number [1]

EC00402

Summary

Brief summary

Cerebral palsy is the most common physical disability in childhood, with a significant lifelong impact on the person, their family and the community. It is estimated that 1:400 children are born with cerebral palsy (Stanley et al, 2000), with over 600 new cases diagnosed in Australia each year. At present there is no known cure for this condition (Stanley et al, 2000) however the methods for the treatment of its symptoms, such as muscle spasticity, are well documented. It is known that the combination of occupational therapy along with botulinum toxin (BOTOX) injections (Lowe, Novak & Cusick, 2005; Wallen, O’Flaherty & Waugh 2004) and best-practice home programs (Novak, Cusick & Lowe, 2005) can produce positive outcomes for improving function and manage the symptoms of spasticity in children with cerebral palsy (Corry & Graham, 1994; Delago, 2002; Leach, 1997; Russman, Tilton & Gromley, 1997). It is therefore worth investigating the nature and extent of parental input and determine whether or not intensive provider delivered therapy intervention following upper limb botulinum toxin injections will lead to greater desirable outcome in the daily functioning of a child with cerebral palsy. The results of this research project will provide valuable data for determining therapy intensity and the conditions and processes that affect the treatment process.  This will help inform decisions by health professionals and families regarding the type, amount, model and method of therapy to be used following BOTOX® injections, thus guiding best practice, use of time, resources and funding in the treatment of spasticity in children with cerebral palsy.  There is thus a clear gap in research literature regarding provider-based intense therapy effectiveness that needs to be filled.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Iona Novak

Address

Cerebral Palsy Alliance
PO Box 6427
Frenchs Forest 2086
NSW

Country

Australia

Phone

+61409078917

Fax

inovak@cerebralpalsy.org.au

Contact person for public queries

Name

Iona Novak

Address

Cerebral Palsy Alliance
PO Box 6427
Frenchs Forest 2086
NSW

Country

Australia

Phone

+61409078917

Fax

inovak@cerebralpalsy.org.au

Contact person for scientific queries

Name

Iona Novak

Address

Cerebral Palsy Alliance
PO Box 6427
Frenchs Forest 2086
NSW

Country

Australia

Phone

+61409078917

Fax

inovak@cerebralpalsy.org.au

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.

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