Condition category
Nervous System Diseases
Date applied
19/03/2017
Date assigned
20/03/2017
Last edited
21/03/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

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

Sponsor information

Organisation

Centre Hospitalier Universitaire Vaudois (CHUV)

Sponsor details

Hôpital Nestlé CHUV
Lausanne
1011
Switzerland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Fondation Leenaards

Alternative name(s)

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

Results - basic reporting

Publication summary

Publication citations

Editorial Notes

21/03/2017: Participant information sheets uploaded.