Contact information
Type
Scientific
Primary contact
Dr Eva Bower
ORCID ID
Contact details
Rehabilitation Research Unit
University of Southampton
Mailpoint 874
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
+44 (0)1703 79 6466
Evabower@talk21.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MCH 13-17
Study information
Scientific title
Acronym
Study hypothesis
Does more intensive physiotherapy or collaborative goal-setting increase motor function or performance in children with cerebral palsy?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled 2x2 factorial design trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/12/1996
Overall trial end date
01/06/1999
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
56 (Added 19/11/09)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/12/1996
Recruitment end date
01/06/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Rehabilitation Research Unit
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Mother and Child Health National Research and Development Programme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11201422
Publication citations
-
Results
Bower E, Michell D, Burnett M, Campbell MJ, McLellan DL, Randomized controlled trial of physiotherapy in 56 children with cerebral palsy followed for 18 months., Dev Med Child Neurol, 2001, 43, 1, 4-15.