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Monitoring Everyday Life Motor Activity in Children

Monitoring Everyday Life Motor Activity in Children

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02236091
Acronym
MELMAC
Enrollment
40
Registered
2014-09-10
Start date
2014-10-31
Completion date
2018-08-21
Last updated
2018-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurologic Disorders

Keywords

cerebral palsy, stroke, traumatic brain injury

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).

Interventions

None listed

Sponsors

Rob Labruyere
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Counts per minute at time point T=0At T=0From the wearable sensors at the wrist, a count/minute statistic is calculated that reflects the amount of activity the child performs during that time.
Counts per minute at time point T=1At T=1 (4 weeks after T=0)From the wearable sensors at the wrist, a count/minute statistic is calculated that reflects the amount of activity the child performs during that time.

Secondary

MeasureTime frameDescription
Motor assessment: Melbourne 2 at time point T=0At T=0The Melbourne Assessment 2: a test of unilateral upper limb function is a validated and reliable tool for evaluating quality of upper limb movement in children with neurological conditions aged 2.5 to 15 years. For ease of use the assessment's full title is simplified to The Melbourne Assessment 2 or MA2. The MA2 is a criterion-referenced test that extends and refines the scale properties of the original Melbourne Assessment. The MA2 measures four elements of upper limb movement quality: movement range, accuracy, dexterity and fluency. It comprises 14 test items of reaching to, grasping, releasing and manipulating simple objects. Each child's test performance is videorecorded for subsequent scoring.
Parent questionnaire: Abilhand-Kids at time point T=0At T=0The ABILHAND-Kids is a measure of manual ability for children with upper limb impairments. The scale measures a person's ability to manage daily activities that require the use of the upper limbs, whatever the strategies involved.
Motor assessment: Melbourne 2 at time point T=1At T=1 (4 weeks after T=0)The Melbourne Assessment 2: a test of unilateral upper limb function is a validated and reliable tool for evaluating quality of upper limb movement in children with neurological conditions aged 2.5 to 15 years. For ease of use the assessment's full title is simplified to The Melbourne Assessment 2 or MA2. The MA2 is a criterion-referenced test that extends and refines the scale properties of the original Melbourne Assessment. The MA2 measures four elements of upper limb movement quality: movement range, accuracy, dexterity and fluency. It comprises 14 test items of reaching to, grasping, releasing and manipulating simple objects. Each child's test performance is videorecorded for subsequent scoring.
Parent questionnaire: Abilhand-Kids at time point T=1At T=1 (4 weeks after T=0)The ABILHAND-Kids is a measure of manual ability for children with upper limb impairments. The scale measures a person's ability to manage daily activities that require the use of the upper limbs, whatever the strategies involved.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026