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
Contact information
Prof Stuart Logan
Scientific
Scientific
Peninsula College of Medicine and Dentistry
St Luke's Campus
Exeter
EX1 2LU
United Kingdom
Study information
| Study design | Multicentre randomised controlled single-blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/04/2006 |
| Completion date | 30/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Peninsula College of Medicine and Dentistry
Exeter
EX1 2LU
United Kingdom
EX1 2LU
United Kingdom
Sponsor information
Royal Devon and Exeter NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Royal Devon and Exeter Hospital (Wonford)
Barrack Road
Exeter
EX2 5DW
England
United Kingdom
| Website | http://www.rdehospital.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/03085z545 |
Funders
Funder type
Charity
The Cerebra Foundation (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
