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

ISRCTN ISRCTN63483122
DOI https://doi.org/10.1186/ISRCTN63483122
Secondary identifying numbers NTR251
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
19/12/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Ms Annelies Hartman
Scientific

Erasmus Medical Centre
Sophia Children's Hospital
Department of Paediatric Physiotherapy
P.O. Box 2060
Amsterdam
3000 CB
Netherlands

Email j.hartman@erasmusmc.nl

Study information

Study designRandomised single-blind active controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study hypothesisPhysiotherapy will diminish the development, extent and duration of motor problems in children with acute lymphoblastic leukaemia.
Ethics approval(s)Received from the local medical ethics committee
ConditionAcute lymphoblastic leukaemia (ALL)
InterventionChildren 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 typeOther
Primary outcome measureMotor 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 measuresObjective signs of polyneuropathy, i.e. decreased reflexes, sensory disturbance and muscle weakness are assessed.
Overall study start date01/03/2001
Overall study end date01/10/2006

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Year
Upper age limit18 Years
SexBoth
Target number of participants52
Participant inclusion criteriaChildren aged 1 - 18 years diagnosed with acute lymphoblastic leukaemia
Participant exclusion criteria1. Additional medical conditions known to have an effect on motor development
2. Cognitive impairment
Recruitment start date01/03/2001
Recruitment end date01/10/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Erasmus Medical Centre
Amsterdam
3000 CB
Netherlands

Sponsor information

Erasmus Medical Centre (Netherlands)
Hospital/treatment centre

Sophia Children's Hospital
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands

Website http://www.erasmusmc.nl/content/englishindex.htm
ROR logo "ROR" https://ror.org/018906e22

Funders

Funder type

Research organisation

Erasmus Medical Centre (The Netherlands) - Revolving Fund

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan