A randomised controlled trial of different intensities of physiotherapy and collaborative goal-setting in children with cerebral palsy.

ISRCTN	ISRCTN88897355
DOI	https://doi.org/10.1186/ISRCTN88897355
Secondary identifying numbers	MCH 13-17

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 19/11/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Eva Bower
Scientific

Rehabilitation Research Unit
University of Southampton
Mailpoint 874
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom

Phone	+44 (0)1703 79 6466
Email	Evabower@talk21.com

Study information

Study design	Randomised controlled 2x2 factorial design trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study objectives	Does more intensive physiotherapy or collaborative goal-setting increase motor function or performance in children with cerebral palsy?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cerebral palsy
Intervention	Following 6 months baseline observation (A), the children were stratified and randomised into 4 treatment groups. A 2x2 factorial design was used to compare current amounts of physiotherapy with intensive amounts and the use of generalised aims with specific, measurable goals negotiated with each child, carer, teacher and the child's own physiotherapist. Following the 6 month treatment period (B),there was a further 6 month period of observation (A). Each child received one of four treatment regimes during the treatment period (B) provided by their own physiotherapist. 1. Current pattern of physiotherapy continued for each child as usual 2. Current pattern of physiotherapy provided more intensively 3. Physiotherapy guided by collaborative goal-setting at the current intensity 4. Physiotherapy guided by collaborative goal-setting and provided more intensively
Intervention type	Other
Primary outcome measure	Changes in motor function and performance were assessed using the Gross Motor Function Measure [Russell et al. 1993] and the Gross Motor Performance Measure [Boyce et al. 1998].
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/12/1996
Completion date	01/06/1999

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	56 (Added 19/11/09)
Key inclusion criteria	A convenience sample of children with bilateral cerebral palsy classified on the Gross Motor Function Classification System [Palisano et al. 1997] living in the community.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/12/1996
Date of final enrolment	01/06/1999

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Rehabilitation Research Unit

Southampton
SO16 6YD
United Kingdom

Sponsor information

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Mother and Child Health National Research and Development Programme (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2001		Yes	No