Condition category
Cancer
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
19/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.erasmusmc.nl/content/englishindex.htm

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

Publication citations

Additional files

Editorial Notes