Osteopathy for children with Cerebral Palsy

ISRCTN	ISRCTN45840554
DOI	https://doi.org/10.1186/ISRCTN45840554
Protocol serial number	609136
Sponsor	Royal Devon and Exeter NHS Foundation Trust (UK)
Funder	The Cerebra Foundation (UK)

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

Contact information

Prof Stuart Logan
Scientific

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

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled single-blind trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	OCP Trial
Study objectives	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(s)	Southwest Research Ethics Committee approved 23rd February 2006 (ref: 06/MRE06/1)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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
Completion date	30/09/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Years
Upper age limit	12 Years
Sex	All
Target sample size at registration	150
Key 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
Key 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
Date of first enrolment	01/04/2006
Date of final enrolment	30/09/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Peninsula College of Medicine and Dentistry

Exeter
EX1 2LU
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes