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 of protocol
Not provided at time of registration
Contact information
Ms Annelies Hartman
Scientific
Scientific
Erasmus Medical Centre
Sophia Children's Hospital
Department of Paediatric Physiotherapy
P.O. Box 2060
Amsterdam
3000 CB
Netherlands
| j.hartman@erasmusmc.nl |
Study information
| Study design | Randomised single-blind active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Physiotherapy 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/03/2001 |
| Completion date | 01/10/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Year |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 52 |
| Key inclusion criteria | Children aged 1 - 18 years diagnosed with acute lymphoblastic leukaemia |
| Key exclusion criteria | 1. Additional medical conditions known to have an effect on motor development 2. Cognitive impairment |
| Date of first enrolment | 01/03/2001 |
| Date of final enrolment | 01/10/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre
Amsterdam
3000 CB
Netherlands
3000 CB
Netherlands
Sponsor information
Erasmus Medical Centre (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Sophia Children's Hospital
Dr. Molewaterplein 60
Rotterdam
3015 GJ
Netherlands
| Website | http://www.erasmusmc.nl/content/englishindex.htm |
|---|---|
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
