Contact information
Type
Scientific
Primary contact
Dr Terry Pountney
ORCID ID
Contact details
Chailey Heritage Clinical Services
Research Department
Beggars Wood Road
North Chailey
Lewes
BN8 4JN
United Kingdom
terry.pountney@southdowns.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6817
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
Acronym
STATbiTR
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Paediatrics
Intervention
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 individuals 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
Other
Phase
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
01/10/2008
Overall trial end date
31/08/2010
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Not Specified
Gender
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
01/10/2008
Recruitment end date
31/08/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Chailey Heritage Clinical Services
Lewes
BN8 4JN
United Kingdom
Sponsor information
Organisation
Sussex NHS Research Consortium (UK)
Sponsor details
Research & Development Department
Worthing Hospital
Lyndhurst Road
Worthing
BN11 2DH
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme
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
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22850757
Publication citations
-
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.