Condition category
Nervous System Diseases
Date applied
29/01/2009
Date assigned
10/02/2009
Last edited
14/07/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.pms.ac.uk/ocp/

Contact information

Type

Scientific

Primary contact

Prof Stuart Logan

ORCID ID

Contact details

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

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 measures

1. 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 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

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

http://www.rdehospital.nhs.uk/

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21349889

Publication citations

  1. 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.

Additional files

Editorial Notes