Condition category
Nervous System Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
19/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes