A randomised controlled pilot study of weight-bearing standing programmes on bone mineral density in non-ambulant cerebral palsy children.
| ISRCTN | ISRCTN90325334 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90325334 |
| Secondary identifying numbers | PCD2/A1/306 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 08/12/2009
- 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
Dr Zulficar Mughal
Scientific
Scientific
Department of Paediactrics
St Mary's Hospital for Women and Children
Hathersage Road
Manchester
M13 0JH
United Kingdom
| Phone | +44 (0)161 276 6501 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The overall objective of this randomised pilot intervention study is to determine whether participation in a weight-bearing standing programme (approximately 50% increase in vertical or prone standing for one year) will lead to an improvement in volumetric bone mineral density of non-ambulant children with cerebral palsy. Please note that as of 26/11/09 this record has been updated. All updates can be found in the relevant field with the above update date. Updated information was taken from 2004 publication (link below). |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cerebral palsy |
| Intervention | Added 26/11/09 A heterogeneous group of 26 pre-pubertal children with CP (14 boys, 12 girls; age 4.3-10.8 years) participated in this randomised controlled trial. Subjects were matched into pairs using baseline vertebral vTBMD standard deviation scores. Children within the pairs were randomly allocated to either intervention (50% increase in the regular standing duration) or control (no increase in the regular standing duration) groups. Pre- and post-trial vertebral and proximal tibial vTBMD was measured by quantitative computed tomography (QCT) |
| Intervention type | Other |
| Primary outcome measure | Change in volumetric bone mineral density |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/11/1997 |
| Completion date | 31/10/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 26 |
| Key inclusion criteria | Non-ambulant cerebral palsy children who are able to weight-bear in a standing frame. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/11/1997 |
| Date of final enrolment | 31/10/2001 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Paediactrics
Manchester
M13 0JH
United Kingdom
M13 0JH
United Kingdom
Sponsor information
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
NHS National Physical and Complex Disabilities Programme (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 | 01/02/2004 | Yes | No |
