Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PCD2/A1/306
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
Change in volumetric bone mineral density
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/1997
Overall trial end date
31/10/2001
Reason abandoned
Eligibility
Participant inclusion criteria
Non-ambulant cerebral palsy children who are able to weight-bear in a standing frame.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
26
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/11/1997
Recruitment end date
31/10/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Paediactrics
Manchester
M13 0JH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS National Physical and Complex Disabilities Programme (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
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14736627
Publication citations
-
Results
Caulton JM, Ward KA, Alsop CW, Dunn G, Adams JE, Mughal MZ, A randomised controlled trial of standing programme on bone mineral density in non-ambulant children with cerebral palsy., Arch. Dis. Child., 2004, 89, 2, 131-135.