Condition category
Nervous System Diseases
Date applied
17/12/2015
Date assigned
18/12/2015
Last edited
18/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Trial website

https://www.zhaw.ch/de/forschung/personen-publikationen-projekte/detailansicht-projekt/projekt/2464/

Contact information

Type

Scientific

Primary contact

Dr Brigitte Elisabeth Gantschnig

ORCID ID

http://orcid.org/0000-0002-3069-6585

Contact details

Research and Development
Institute of Occupational Therapy
School of Health Professions
ZHAW Zurich University of Applied Sciences
Technikumstrasse 71
Postfach
Winterthur
8401
Switzerland

Additional identifiers

EudraCT number

2015-004581-28

ClinicalTrials.gov number

Protocol/serial number

EKSG 15/087

Study information

Scientific title

Powered mobility training in young children with cerebral palsy: A single-case 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

Ethics board of the Canton St. Gall, Switzerland, 02/07/2015, ref: EKSG 15/087

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

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/11/2015

Overall trial end date

28/02/2017

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

10

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

Trial participating centre

Eastern Swiss Children's Hospital
Centre of Neurology Development and Rehabilitation – KER-centre
St. Gall
9006
Switzerland

Sponsor information

Organisation

ZHAW Zurich University of Applied Sciences

Sponsor details

Research and Development
Institute of Occupational Therapy
School of Health Professions
ZHAW Zurich University of Applied Sciences
Technikumstrasse 71
Postfach
Winterthur
8401
Switzerland

Sponsor type

University/education

Website

https://www.zhaw.ch/de/gesundheit/

Funders

Funder type

Research organisation

Funder name

Foundation for occupational therapy Zurich (Stiftung für Ergotherapie Zürich)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cerebral Foundation (Stiftung Cerebral)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ebnet Foundation (Ebnet Stiftung)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Foundation for Western culture (Stiftung für Abendländische Kultur)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

01/06/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes