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The effect of physiotherapy on development, extent and duration of motor problems in children with acute lymphoblastic leukaemia.


- candidate number1432
- NTR NumberNTR251
- ISRCTNISRCTN63483122
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR7-sep-2005
- Secondary IDsN/A 
- Public TitleThe effect of physiotherapy on development, extent and duration of motor problems in children with acute lymphoblastic leukaemia.
- Scientific TitleThe effect of physiotherapy on development, extent and duration of motor problems in children with acute lymphoblastic leukaemia.
- ACRONYMN/A
- hypothesisPhysiotherapy will diminish the development , extent and duration of motor problems in children with acute lymphoblastic leukaemia.
- Healt Condition(s) or Problem(s) studiedAcute Lymphoblastic Leukemia
- Inclusion criteriaChildren, aged 1-18 years diagnosed with acute lymphoblastic leukaemia.
- Exclusion criteria1. Additional medical conditions known to have an effect on motor development;
2. Cognitive impairment.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2001
- planned closingdate1-okt-2006
- Target number of participants52
- InterventionsChildren 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.
- Primary outcomeMotor 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 outcomeObjective signs of polyneuropathy i.e. decreased reflexes, sensory disturbance and muscle weakness are assessed.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES Annelies Hartman
- CONTACT for SCIENTIFIC QUERIES Annelies Hartman
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center Revolving Fund
- PublicationsN/A
- Brief summaryChildren 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.
- Main changes (audit trail)
- RECORD7-sep-2005 - 2-sep-2009


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