Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Terry Pountney


Contact details

Chailey Heritage Clinical Services
Research Department
Beggars Wood Road
North Chailey
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Effectiveness and feasibility of intensive short-term graded exercise programmes, using either treadmill or static exercise bicycle for non-ambulant children and young people with cerebral palsy in improving functional motor ability and quality of life



Study hypothesis

Effectiveness and feasibility of intensive short-term graded exercise programmes, using either treadmill or static exercise bicycle for non-ambulant children and young people with cerebral palsy in improving functional motor ability and quality of life.

Ethics approval

Brighton West Research Ethics Committee approved on the 20th June 2008 (ref: 08/H1111/30)

Study design

Multicentre randomised interventional process of care trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Paediatrics


A mixed methodology comprising the following two sub-studies:
1. Parallel arm randomised controlled trial evaluating programme effectiveness
2. A focus group-based qualitative study evaluating programme acceptability and feasibility

1. Parallel arm randomised controlled trial:
Primary outcome measure: Gross Motor Function Measure (GMFM)-88E
Secondary outcome measures: GMFM-88D, GMFM-66, Kidscreen-52 Quality of Life Health Questionnaire for Children and Young People

Outline of measures:
The GMFM-88D and GMFM-88E measure functional activity in children with CP. It is a standardised measure for use in children between the ages of 5 months and 16 years old. The GMFM-66 is a shorter version of the GMFM-88 and provides facility to convert scores to an interval scale. However, it can be insensitive at low levels and hence both measures will be administered. KIDSCREEN-52 A quality of life questionnaire will be completed by each child before and after the study. This Health-Related Quality of Life Measure is one of the 4 questionnaires, highly evaluated in the Asqme report and has been shown to provide valid results for health status, functional limitations and well-being.

Young people taking part in the focus groups are likely to use alternative and/or augmentative communication and this will require novel approaches to facilitate the groups and the use of pictures and models to aid discussion. The child's Speech & Language Therapist will be consulted regarding his/her form of communication. Advocates who know a child will be used to help children communicate if they wish. Eligible children/young people who consent to participate will be randomised to receive either:
1.1. Continuation of individual’s standard physiotherapy programme (control arm).
1.2. 6 week intensive graded exercise programme using a static bicycle
1.3. 6 week intensive graded exercise programme using a treadmill

Assessment of all outcome measures will be taken at baseline, immediately post-intervention, 6 and 12 weeks post-intervention, by a researcher blinded to the study arm allocations. All assessments and interventions will be carried out in physiotherapy departments at participating sites, to minimise costs and inconvenience to participants.

Intervention type



Not Applicable

Drug names

Primary outcome measure

1. Gross Motor Function Measure-66, 88D and 88E
2. Kidscreen 27 (quality of life measure)

Secondary outcome measures

No secondary outcome measures

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Children and young people cerebral palsy at Gross Motor Function Classification System (GMFCS) levels IV and V as this is the population for which exercise to be used
2. Aged 8 to 17 years - 8 years as tall enough to use trike and 17 years as research is taking place largely in schools and this would be upper limit to complete the study
3. Ability to pedal on a static bicycle and take steps on the treadmill when given additional postural support
4. Ability to follow the instructions needed for different aspects of graded exercise

Participant type


Age group

Not Specified


Not Specified

Target number of participants

Planned sample size: 36

Participant exclusion criteria

1. History of fracture to legs - may be vulnerable to further fracture
2. Cardiovascular disease - risk of heart/respiratory problems

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Chailey Heritage Clinical Services
United Kingdom

Sponsor information


Sussex NHS Research Consortium (UK)

Sponsor details

Research & Development Department
Worthing Hospital
Lyndhurst Road
BN11 2DH
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2013 results in:

Publication citations

  1. Results

    Bryant E, Pountney T, Williams H, Edelman N, Can a six-week exercise intervention improve gross motor function for non-ambulant children with cerebral palsy? A pilot randomized controlled trial., Clin Rehabil, 2013, 27, 2, 150-159, doi: 10.1177/0269215512453061.

Additional files

Editorial Notes