Neurologic Disorders Clinical Trial
— MELMACOfficial title:
Monitoring Everyday Life Motor Activity in Children
NCT number | NCT02236091 |
Other study ID # | MELMAC |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | October 2014 |
Est. completion date | August 21, 2018 |
Verified date | October 2018 |
Source | University Children's Hospital, Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Terminated |
Enrollment | 40 |
Est. completion date | August 21, 2018 |
Est. primary completion date | July 14, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 18 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Rehabilitation Center of the Children's University Hospital | Affoltern am Albis |
Lead Sponsor | Collaborator |
---|---|
Rob Labruyere |
Switzerland,
Strohrmann C, Labruyère R, Gerber CN, van Hedel HJ, Arnrich B, Tröster 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Counts per minute at time point 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. | At T=0 | |
Primary | Counts per minute at time point T=1 | 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. | At T=1 (4 weeks after T=0) | |
Secondary | Motor assessment: Melbourne 2 at time point 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. |
At T=0 | |
Secondary | Parent questionnaire: Abilhand-Kids at time point 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. | At T=0 | |
Secondary | Motor assessment: Melbourne 2 at time point T=1 | 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. |
At T=1 (4 weeks after T=0) | |
Secondary | Parent questionnaire: Abilhand-Kids at time point T=1 | 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. | At T=1 (4 weeks after T=0) |
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