Powered mobility training for young children with disability
| ISRCTN | ISRCTN34030148 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34030148 |
| EudraCT/CTIS number | 2015-004581-28 |
| Secondary identifying numbers | EKSG 15/087 |
- Submission date
- 17/12/2015
- Registration date
- 18/12/2015
- Last edited
- 18/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Cerebral palsy (CP) is a condition which affects movement, posture and coordination. It is caused by an injury to the parts of the brain responsible for controlling muscles, usually before or very soon after birth. Children who are suffering from CP struggle to control movement which can affect their mobility (ability to walk) and stop them from taking part in certain activities at home and at school. Many studies have shown that helping children to regain their mobility using electric wheelchairs (powered mobility) can be extremely beneficial for their development, independence and self-esteem. Although many older children can access powered mobility training (sessions where they learn how to use their electric wheelchair), programs for very young children are currently lacking. The aim of this study is to test the effectiveness of powered mobility training in very young children with CP.
Who can participate?
Children aged between 2 and 4 who have been diagnosed with CP within the last 6 months and are able to sit up and control their head movements without support.
What does the study involve?
At the start of the study, the children’s functioning abilities (mobility and independence) are tested using a number of assessments. Questionnaires are also filled in by parents in order to measure the children’s quality of life and social interaction with other children. The participants then continue for 4 months without any powered mobility training (control phase). After four months, the initial assessments are repeated. The children then receive weekly powered mobility training sessions lasting for 45-60 minutes over a period of four months, teaching them how to use electric wheelchairs. After 4 months, the children are assessed again to evaluate the effectiveness of the powered mobility training. The measurements are also taken at 12 and 16 months to look at the long term effects of taking part in the mobility training.
What are the possible benefits and risks of participating?
The children taking part in the study can directly benefit, as the powered mobility training will help with their mobility. There are no notable risks of taking part in this study.
Where is the study run from?
Eastern Swiss Children’s Hospital (Switzerland)
When is the study starting and how long is it expected to run for?
November 2015 to February 2017
Who is funding the study?
1. Foundation for occupational therapy Zurich (Switzerland)
2. Cerebral Foundation (Switzerland)
3. Ebnet Foundation (Switzerland)
4. Foundation for Western culture (Switzerland)
Who is the main contact?
Dr Brigitte Elisabeth Gantschnig
Contact information
Scientific
Research and Development
Institute of Occupational Therapy
School of Health Professions
ZHAW Zurich University of Applied Sciences
Technikumstrasse 71, Postfach
Winterthur
8401
Switzerland
 ORCID ID |
0000-0002-3069-6585 |
|---|
Study information
| Study design | Single-centre single-case study using time series A-B-A-B-design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Single case study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | Powered mobility training in young children with cerebral palsy: A single-case study |
| Study acronym | Powered mobility for children |
| Study hypothesis | The aim of this study is to evaluate the effectiveness of early powered mobility training in children with cerebral palsy between the ages of 2 and 4 years. The specific research question is: How effective is early powered mobility training in children with cerebral palsy on: 1. Moving distance 2. Learning to use a powered wheelchair 3. Quality of ADL task performance 4. Quality of social interaction 5. Quality of life |
| Ethics approval(s) | Ethics board of the Canton St. Gall, Switzerland, 02/07/2015, ref: EKSG 15/087 |
| Condition | Cerebral palsy |
| Intervention | A time series design (A-B-A-B-design) with repeated measures is used for this single case study. Thus, the participants act as their own controls. After baseline evaluation (i.e. the first measure at time 1 [t1]), participants start with phase A (control phase). Participants receive no powered mobility training during this control phase that lasts 4 months. Then, another evaluation is implemented (i.e. the second measure at time 2 [t2]), followed by an intervention phase B. During the phase B participants receive powered mobility training. The powered mobility training is implemented in weekly session, 45 to 60 minutes each, over 4 months. It is based on Nilsson’s work about the Driving to Learn method and the works of Durkin and Nilsson involving outcome assessment and facilitating strategies of learning powered mobility use. We use their work as an intervention protocol that supports occupational therapists with general (e.g. provide participants with activities with the right challenge) and specific (e.g. use specific langue in different learning phases) facilitating strategies as they implement powered mobility training. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Mobility is assessed using the driving distance (meters/session) at baseline, 4, 8, 12 and 16 months. |
| Secondary outcome measures | 1. Quality of ADL task performance is determined using the Assessment of Motor and Process Skills (AMPS), is a standardised observational assessment at baseline, 4, 8, 12 and 16 months 2. Level of mastery and independence in specific ADL tasks is measured using the Pediatric Evaluation of Disability Inventory (PEDI) completed by parents at baseline, 4, 8, 12 and 16 months 3. Quality of social interaction in children with CP is measured using the Evaluation of Social Interaction (ESI), a standardised observational assessment, at baseline, 4, 8, 12 and 16 months 4. Children’s process of learning powered mobility use is measured using the Assessment of Learning Powered mobility use (ALP), an observational assessment, at baseline, 4, 8, 12 and 16 months |
| Overall study start date | 01/11/2015 |
| Overall study end date | 28/02/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 4 Years |
| Sex | Both |
| Target number of participants | 10 |
| Participant inclusion criteria | 1. Aged between 2 and 4 years 2. diagnosed within the last 6 months with infantile cerebral palsy according to ICD-10 G80 criteria 3. GMFCS level II to IV 4. MACS Level II to IV 5. Able to sit in the seat with physical support 6. Able to control their head and no risk of hurting themselves 7. Good general health condition |
| Participant exclusion criteria | 1. Those who are not able to sit without support 2. Those who cannot control their head position 3. Those who have a instable health status 4. Those whose parents did not agree to participate in the study |
| Recruitment start date | 01/11/2015 |
| Recruitment end date | 31/12/2015 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Development and Rehabilitation – KER-centre
St. Gall
9006
Switzerland
Sponsor information
University/education
Research and Development
Institute of Occupational Therapy
School of Health Professions
ZHAW Zurich University of Applied Sciences
Technikumstrasse 71, Postfach
Winterthur
8401
Switzerland
| Website | https://www.zhaw.ch/de/gesundheit/ |
|---|---|
"ROR" |
https://ror.org/05pmsvm27 |
Funders
Funder type
Research organisation
No information available
No information available
No information available
No information available
Results and Publications
| Intention to publish date | 01/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication of study results in at least one international journal, with other publication in national journals and at national and international congresses. The results will also be shared with stakeholders, such as parents of children with CP, neuropaediatricians, physical therapists, other rehabilitation professionals, and the CP foundation in Switzerland. |
| IPD sharing plan |
