Osteopathy for children with Cerebral Palsy

ISRCTN ISRCTN45840554
DOI https://doi.org/10.1186/ISRCTN45840554
Secondary identifying numbers 609136
Submission date
29/01/2009
Registration date
10/02/2009
Last edited
14/07/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Stuart Logan
Scientific

Peninsula College of Medicine and Dentistry
St Luke's Campus
Exeter
EX1 2LU
United Kingdom

Study information

Study designMulticentre randomised controlled single-blind trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleOsteopathy 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
Study acronymOCP Trial
Study objectivesIn 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(s)Southwest Research Ethics Committee approved 23rd February 2006 (ref: 06/MRE06/1)
Health condition(s) or problem(s) studiedCerebral palsy
InterventionIntervention 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 typeOther
Primary outcome measure1. Gross Motor Function Measure assessed by a physiotherapist at 6 months, blinded to the child’s 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 measures1. 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 study start date01/04/2006
Completion date30/09/2008

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit5 Years
Upper age limit12 Years
SexAll
Target number of participants150
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/04/2006
Date of final enrolment30/09/2008

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Peninsula College of Medicine and Dentistry
Exeter
EX1 2LU
United Kingdom

Sponsor information

Funders

Funder type

Charity

The Cerebra Foundation (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2011 Yes No
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