Condition category
Nervous System Diseases
Date applied
18/06/2010
Date assigned
18/06/2010
Last edited
29/08/2013
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 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 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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

http://www.sxrc.nhs.uk/

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22850757

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