Clinical trial NCT02236091: Monitoring Everyday Life Motor Activity in Children
Official title: Monitoring Everyday Life Motor Activity in Children
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Neurologic Disorders
Keywords: cerebral palsy
stroke
traumatic brain injury
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2014-09-10
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be inpatients from our rehabilitation center and will be recruited directly by researchers working on this project

Brief summary: The overall aim of this project is to monitor everyday life activity of children with neurological disorders undergoing rehabilitation using wearable sensors capable of accurate and unobtrusive long-term measurement.

Specific objectives:

1. To adapt the sensors for the use by children with neurological disorders. The focus lies on the exact positioning and the investigation of the needed amount of IMUs.
2. To validate the sensor data with collected video recordings and to develop specific algorithms to automatically extract specific movements and to analyze long-term sensor recordings.
3. To perform a cross-sectional study to assess intensity, task-specificity and duration of upper and lower limb activity during rehabilitation. There, we aim to gain objective information about levels and types of activity during rehabilitation in relation to age, gender and disorder.
4. To conduct a responsiveness study to assess whether or not the sensor output is able to highlight changes over time during rehabilitation.

Therefore, at time point T=0 (shortly after admission to our center), participants are equipped with 3 inertial measurement units (1 at each wrist and 1 at the sternum). Additionally, a small wearable camera is mounted to the chest. The participants then return to their everyday life for 4 hours (no therapies, measurement period is in the evening). Afterwards, the equipment is removed again. To investigate responsiveness, the same protocol is being repeated 4 weeks later (time point T=1).


Eligibility criteria: Inclusion Criteria:

* Various neuro-orthopedic diagnoses. Broad inclusion criteria are required to better generalize study results to the patient population of our center.
* Both walking or in wheelchair, but mobility independent from assisting people
* Cognitive ability to be able to follow simple verbal instructions.
* Signed informed consent from legal guardians and also from adolescents aged 15 years or older before study onset.

Primary outcomes:
measure: Counts per minute at time point T=0
timeFrame: At T=0
measure: Counts per minute at time point T=1
timeFrame: At T=1 (4 weeks after T=0)
Secondary outcomes:
measure: Motor assessment: Melbourne 2 at time point T=0
timeFrame: At T=0
measure: Parent questionnaire: Abilhand-Kids at time point T=0
timeFrame: At T=0
measure: Motor assessment: Melbourne 2 at time point T=1
timeFrame: At T=1 (4 weeks after T=0)
measure: Parent questionnaire: Abilhand-Kids at time point T=1
timeFrame: At T=1 (4 weeks after T=0)
Other outcomes:
Locations:
city: Affoltern am Albis
country: Switzerland
facility: Rehabilitation Center of the Children's University Hospital
Study officials:
affiliation: Children's University Hospital Zurich
name: Rob Labruyère, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Strohrmann C, Labruyere R, Gerber CN, van Hedel HJ, Arnrich B, Troster G. Monitoring motor capacity changes of children during rehabilitation using body-worn sensors. J Neuroeng Rehabil. 2013 Jul 30;10:83. doi: 10.1186/1743-0003-10-83.