|
ISRCTN
|
ISRCTN77274716
|
|
DOI
|
10.1186/ISRCTN77274716
|
|
ClinicalTrials.gov identifier
|
|
|
EudraCT number
|
|
|
Public title
|
The effects of a functional fitness training in children with cerebral palsy
|
|
Scientific title
|
|
|
Acronym
|
FITPRO-CP
|
|
Serial number at source
|
05-092
|
|
Study hypothesis
|
Children with cerebral palsy will benefit from functional fitness training.
|
|
Lay summary
|
|
|
Ethics approval
|
Ethics approval received from the local medical ethics committee
|
|
Study design
|
Multicentre, randomised, single blinded, active controlled, parallel group trial
|
|
Countries of recruitment
|
Netherlands
|
|
Disease/condition/study domain
|
Cerebral parese (cerebral palsy)
|
|
Participants - inclusion criteria
|
1. Cerebral palsy
2. Gross Motor Function Classification System (GMFCS) I or II
3. Age 7 - 20 years
4. Informed consent
|
|
Participants - exclusion criteria
|
1. Cardiac or respiratory conditions that may be affected by exercise
2. Surgical or orthopaedic procedures during or up to three months prior to the study
|
|
Anticipated start date
|
15/10/2005
|
|
Anticipated end date
|
15/06/2006
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
100
|
|
Interventions
|
Fitness programme that consists of functional exercises. 45 minutes fitness training twice a week for 8 months.
|
|
Primary outcome measure(s)
|
Aerobic capacity.
|
|
Secondary outcome measure(s)
|
1. Activities of daily life
2. Participation
3. Competence
4. Quality of life
|
|
Sources of funding
|
Dr WM Phelps-Stichting Voor Spastici (The Netherlands)
|
|
Trial website
|
http://www.netchild.nl
|
|
Publications
|
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17984410
|
|
Contact name
|
Dr
Olaf
Verschuren
|
|
Address
|
Revalidatiecentrum De Hoogstraat
Rembrandtkade 10
|
|
City/town
|
Utrecht
|
|
Zip/Postcode
|
3583 TM
|
|
Country
|
Netherlands
|
|
Tel
|
+31 (0)30 2561211
|
|
Email
|
o.verschuren@dehoogstraat.nl
|
|
Sponsor
|
University Medical Center Utrecht (The Netherlands)
|
|
Address
|
WKZ, Department of Pediatric Physiotherapy
Lundlaan 6
|
|
City/town
|
Amsterdam
|
|
Zip/Postcode
|
3584 EA
|
|
Country
|
Netherlands
|
|
Tel
|
+31 (0)30 2504030
|
|
Fax
|
+31 (0)30 2505333
|
|
Email
|
p.j.m.helders@umcutrecht.nl
|
|
Sponsor website:
|
http://www.umcutrecht.nl/zorg/
|
|
Date applied
|
20/12/2005
|
|
Last edited
|
07/11/2007
|
|
Date ISRCTN assigned
|
20/12/2005
|
