Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
609136
Study information
Scientific title
Osteopathy for children with Cerebral Palsy: a randomised controlled trial of the effects of osteopathy on the health and well being of children with cerebral palsy
Acronym
OCP Trial
Study hypothesis
In children aged 5 - 12 years of age with a diagnosis of cerebral palsy does osteopathy, compared to treatment as usual, produce improved motor function, improved quality of life, improved sleep or a reduction in fits?
Ethics approval
Southwest Research Ethics Committee approved 23rd February 2006 (ref: 06/MRE06/1)
Study design
Multicentre randomised controlled single-blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cerebral palsy
Intervention
Intervention group: six sessions of between 30 - 45 minutes duration of osteopathic treatment administered by General Osteopathic Council registered osteopaths over a six month period
Control group: waiting list control receives no treatment
Participants in both arms were in the trial for a total of six months.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Gross Motor Function Measure assessed by a physiotherapist at 6 months, blinded to the childs allocation group
2. Child Health Questionnaire at baseline, 10 weeks and 6 months (please note that due to an update to this record on 03/02/2010, this outcome was upgraded from a secondary outcome to a primary outcome)
Secondary outcome measures
1. Paediatric Pain Profile at baseline, 10 weeks and 6 months
2. 36-item Short Form Health Survey (SF36) at at baseline, 10 weeks and 6 months
3. Sleep and Fit Diary at at baseline, 10 weeks and 6 months
4. Child Self-Report Pain Measure at at baseline, 10 weeks and 6 months
5. General Global Assessment of Health at 10 weeks and 6 months
Overall trial start date
01/04/2006
Overall trial end date
30/09/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children with moderate to severe cerebral palsy classified as categories 2 - 5 of the Gross Motor Function Classification System
2. Aged 5 - 12 years, either sex
3. Live in study area, i.e. Devon or Greater London
4. At least one English speaking and literate parent
5. Must live at home with their parents/carers
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Classified as category 1 of the Gross Motor Function Classification System
2. Those who have had osteopathy within the previous year
3. Those who live in residential school
Recruitment start date
01/04/2006
Recruitment end date
30/09/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Peninsula College of Medicine and Dentistry
Exeter
EX1 2LU
United Kingdom
Sponsor information
Organisation
Royal Devon and Exeter NHS Foundation Trust (UK)
Sponsor details
Royal Devon and Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
The Cerebra Foundation (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
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21349889
Publication citations
-
Results
Wyatt K, Edwards V, Franck L, Britten N, Creanor S, Maddick A, Logan S, Cranial osteopathy for children with cerebral palsy: a randomised controlled trial., Arch. Dis. Child., 2011, 96, 6, 505-512, doi: 10.1136/adc.2010.199877.