Condition category
Nervous System Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
08/12/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Zulficar Mughal

ORCID ID

Contact details

Department of Paediactrics
St Mary's Hospital for Women and Children
Hathersage Road
Manchester
M13 0JH
United Kingdom
+44 (0)161 276 6501

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes