No registrations found.
Source
Brief title
Health condition
Acute lymphoblastic leukaemia.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
Objective signs of polyneuropathy i.e. decreased reflexes, sensory disturbance and muscle weakness are assessed.
Background summary
Children diagnosed with acute lymphoblastic leukaemia are randomised to a physiotherapy (PT) group or to a control group.
Children who are randomised to the PT group receive a standardised exercise program, which starts in week 1 of their chemotherapy treatment, is carried out at home and monitered by a physiotherapist.
Children who are randomised to the control group, only receive physiotherapy if motor problems occur.
This is current standard practice. Motor performance of the children is measured at the onset of chemotherapy, after six weeks, one year after starting chemotherapy, on completion of chemotherapy.
Objective signs of polyneuropathy, i.e. decreased reflexes, sensory disturbance and muscle weakness are assessed.
The assessor is kept blind to the group to which the children are randomised.
Study objective
Physiotherapy will diminish the development , extent and duration of motor problems in children with acute lymphoblastic leukaemia.
Study design
N/A
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.
P.O. Box 2060
Annelies Hartman
Amsterdam 3000 CB
The Netherlands
j.hartman@erasmusmc.nl
P.O. Box 2060
Annelies Hartman
Amsterdam 3000 CB
The Netherlands
j.hartman@erasmusmc.nl
Inclusion criteria
Children, aged 1-18 years diagnosed with acute lymphoblastic leukaemia.
Exclusion criteria
1. Additional medical conditions known to have an effect on motor development;
2. Cognitive impairment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL213 |
NTR-old | NTR251 |
Other | : N/A |
ISRCTN | ISRCTN63483122 |