Contact information
Type
Scientific
Primary contact
Ms Annelies Hartman
ORCID ID
Contact details
Erasmus Medical Centre
Sophia Children's Hospital
Department of Paediatric Physiotherapy
P.O. Box 2060
Amsterdam
3000 CB
Netherlands
j.hartman@erasmusmc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR251
Study information
Scientific title
Acronym
Study hypothesis
Physiotherapy will diminish the development, extent and duration of motor problems in children with acute lymphoblastic leukaemia.
Ethics approval
Received from the local medical ethics committee
Study design
Randomised single-blind active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Acute lymphoblastic leukaemia (ALL)
Intervention
Children who are randomised to the physiotherapy group receive a standardised exercise program, which starts in week 1 of their chemotherapy treatment, is carried out at home and monitored by a physiotherapist.
Children who are randomised to the control group, only receive physiotherapy if motor problems occur. This is current standard practice.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Motor performance is measured with the Motor Assessment Battery for Children - a standardised test for motor performance - at the onset of chemotherapy, after six weeks, one year after starting chemotherapy and on completion of therapy.
Secondary outcome measures
Objective signs of polyneuropathy, i.e. decreased reflexes, sensory disturbance and muscle weakness are assessed.
Overall trial start date
01/03/2001
Overall trial end date
01/10/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Children aged 1 - 18 years diagnosed with acute lymphoblastic leukaemia
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
52
Participant exclusion criteria
1. Additional medical conditions known to have an effect on motor development
2. Cognitive impairment
Recruitment start date
01/03/2001
Recruitment end date
01/10/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus Medical Centre
Amsterdam
3000 CB
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (Netherlands)
Sponsor details
Sophia Children's Hospital
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Erasmus Medical Centre (The Netherlands) - Revolving Fund
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