Plain English Summary
Background and study aims
Cerebral palsy is the general term for a number of conditions caused by problems in the brain and nervous system that affect movement and co-ordination. The condition can occur if the brain develops abnormally or is damaged before, during or shortly after birth. Clinicians need a feasible and precise evaluation of motor (movement) impairments, as well as their causes and their consequences for daily life, not only to establish treatment strategies but also to measure the effectiveness of treatment. The aim of this study is to measure the motor performance of children during their daily life using portable and unobtrusive movement sensors. On the basis of these measures, specific goals are set, an individualized treatment plan is made, and the treatment outcome is measured for each participant.
Who can participate?
Children and adolescents aged 7-18 with a diagnosis of cerebral palsy
What does the study involve?
All participants are tested on four occasions. The first evaluation (week 0) is carried out over two days. On the first day, the participant is equipped with the movement sensors and carries them for 10 hours. On the second day, the participant’s motor capacity is tested and goals are set on what the participant would like to achieve. The second evaluation (week 4) includes another 10 hour measurement with the sensors. In the same week, the participant receives an individualized treatment plan with exercises and behavioural patterns they should perform during the following 4 weeks. This treatment plan is followed at home and in the community with the goal to increase the time spent walking and/or the level of physical activity and/or gait (walking) quality. The third evaluation (week 8) is again performed on two days. The first assessment is another 10 hour measurement with the sensors, while the second assessment comprises the motor capacity test (same as week 0) and the attainment of the goals set at week 0. At the last evaluation (week 12), participants again wear the sensors during one day (10 hours) and the attainment of the goals is checked a second time.
What are the possible benefits and risks of participating?
The results will show whether data from the movement sensors are appropriate for motivating participants and for making individualized physical training programs that improve participants’ physical performance in daily life. There is only minimal risk associated with this study, there are no known undesirable effects with inertial sensors, and there is no pain involved in this study. However, potential unknown risks cannot be excluded. The risk of unauthorized data access and/or unwanted identification of participants is very low, as all the data will be encoded.
Where is the study run from?
Centre Hospitalier Universitaire Vaudois (CHUV) (Switzerland)
When is the study starting and how long is it expected to run for?
February 2017 to December 2017
Who is funding the study?
Fondation Leenaards (Switzerland)
Who is the main contact?
Dr Corinna Gerber
corinna.gerber@chuv.ch
Trial website
Contact information
Type
Scientific
Primary contact
Dr Corinna Gerber
ORCID ID
http://orcid.org/0000-0002-3353-0038
Contact details
CHUV
UNRP
Hôpital Nestle
Lausanne
1011
Switzerland
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2016-01831
Study information
Scientific title
Performance during daily life assessed with wearable motion sensors to guide therapy in children with cerebral palsy: a pilot study
Acronym
CP_Perform
Study hypothesis
An effective training plan can be developed based on the results of the baseline performance, measured with inertial sensors. Furthermore, the improvements due to the intervention are measurable with the same assessment method.
Ethics approval
Commission cantonale d'éthique de la recherche sur l'être humain (CER-VD), Switzerland - Cantonal ethics committee for research with human beings, Vaud, Switzerland, 20/02/2017, ref: 2016.01831
Study design
Single-center longitudinal multiple single-case ABA design
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Community
Trial type
Treatment
Patient information sheet
See additional files
Condition
Cerebral palsy
Intervention
All participants will be tested on four occasions (six visits): Baseline (week 0), pre (week 4), post (week 8), follow-up (week 12). Between the baseline and the pre, as well as between the post and the follow-up, participants will follow their usual treatments. In the middle of the study, from week 5 until the end of week 8, participants will perform an individualized treatment plan in their community setting additionally to their usual treatments.
Assessments:
The study will take place over 12 weeks with four evaluation time-points including six visits.
The first evaluation (week 0) will be done on two days. The first day, the patient will be equipped with the inertial sensors and carry them for 10 consecutive hours. On the second day, the participants motor capacity will be tested with the Gross Motor Function Measure (GMFM, lasting about 45 minutes) and goals will be set on what the patient would like to achieve with the help of the intervention (duration approximately 15 minutes).
The second evaluation (week 4) will include the repetition of the 10 hours measurement with the inertial sensors. In the same week, the participant will receive an individualized treatment plan with exercises and desired behavioral patterns they should perform during the following four weeks.
The third evaluation (week 8) will again be performed on two days. The first assessment will be again a repetition of the 10 hours measurement with the inertial sensors, while the second one comprises the GMFM (same at week 0) and the control of attainment of the goals set at baseline (week 0).
At the last evaluation time-point (week 12), participants will again wear the inertial sensors during one day (10 hours) and the attainment of the goals set at baseline (week 0) will be checked a second time.
Intervention:
On the basis of the capacity (GMFM) and performance (inertial sensors) measures at baseline (week 0), the patient’s habitual physiotherapist will elaborate an individual treatment plan for the patient. This treatment plan will be followed at home and in the community with the goal to augment the time spent walking and/or the level of physical activity and/or gait quality. Participants will follow this treatment plan during four weeks (weeks 5-8). During this treatment phase, participants will follow the usual quantity of therapies. However, during usual these therapies, the physiotherapists will focus on the same goals that were established individually for each patient at the baseline measure of the study.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Daily life gait performance corresponding to the individual goals of each participant (e.g. improvement in gait symmetry)
2. Physical activity levels (i.e. amount of time spent walking and/or in moderate to intensive physical activity)
Both measured using a 10h measurement of daily activity using inertial motion sensors, the Physilog(R) 4 sensors (GaitUp, Switzerland), at baseline (BL) (week 0), pre (BL + 4 weeks), post (BL + 8 weeks), follow-up (BL + 12 weeks)
Secondary outcome measures
1. Gross motor capacity, measured using the Gross Motor Function Measure 66 (GMFM-66) at BL and post
2. Goal attainment, measured using Goal Attainment Scaling (GAS) at BL, post and follow-up
3. Time taken for donning and doffing of sensors, recorded in the CRF at all four time-points (baseline, pre, post, follow-up)
4. Sensor data analysis within the two weeks after the baseline measurement of each patient
5. Feasibility of using the Physilog® inertial sensors for treatment planning in an outpatient setting, assessed with a semi-structured interview with physiotherapists after the follow-up measurement
Overall trial start date
20/02/2017
Overall trial end date
31/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Informed consent as documented by signature (Appendix Informed Consent Form)
2. Diagnosis of cerebral palsy
3. Gross Motor Function Classification System (GMFCS) level I-III
4. Aged 7 to 18 years
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Surgery at the trunk or lower limb level within the last six months
2. Botulinum toxin injection in the trunk or lower limbs within the last three months
3. Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc)
4. Known or suspected non-compliance
5. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders etc of the participant
6. Participation in another study including intensive therapy of the lower limbs within the 30 days preceding and during the present study
7. Intensive gait therapy within the 30 days preceding and during the present study
8. Inpatient rehabilitation stay aimed at improving gait within the 30 days preceding and during the present study
9. Previous enrolment into the current study
10. Mental age < 7 years
11. Severe visual impairments
Recruitment start date
23/03/2017
Recruitment end date
20/10/2017
Locations
Countries of recruitment
Switzerland
Trial participating centre
Centre Hospitalier Universitaire Vaudois
Lausanne
1011
Switzerland
Funders
Funder type
Charity
Funder name
Fondation Leenaards
Alternative name(s)
Leenaards Foundation
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Switzerland
Results and Publications
Publication and dissemination plan
The trialists plan to publish the results of the trial in a high-impact peer reviewed rehabilitation journal by the end of 2018.
IPD sharing plan
As these are patient related data and patients as well as their legal guardians only give informed consent to use data for this specific study, the trialists cannot provide any study data. All data will be stored at the Department Woman-Mother-Child at CHUV in Lausanne.
Intention to publish date
31/12/2018
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN11365830_PIS_20Mar17__caregivers.docx Uploaded 21/03/2017
- ISRCTN11365830_PIS_20Mar17_11-13.docx Uploaded 21/03/2017
- ISRCTN11365830_PIS_20Mar17_14 and older.docx Uploaded 21/03/2017