- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02236091
Monitoring Everyday Life Motor Activity in Children (MELMAC)
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:
- 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.
- 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.
- 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.
- 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).
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Affoltern am Albis, Switzerland, 8910
- Rehabilitation Center of the Children's University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Inpatients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Counts per minute at time point T=0
Time Frame: At T=0
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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.
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At T=0
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Counts per minute at time point T=1
Time Frame: At T=1 (4 weeks after T=0)
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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.
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At T=1 (4 weeks after T=0)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor assessment: Melbourne 2 at time point T=0
Time Frame: At T=0
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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
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Parent questionnaire: Abilhand-Kids at time point T=0
Time Frame: At T=0
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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.
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At T=0
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Motor assessment: Melbourne 2 at time point T=1
Time Frame: At T=1 (4 weeks after T=0)
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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)
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Parent questionnaire: Abilhand-Kids at time point T=1
Time Frame: At 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.
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At T=1 (4 weeks after T=0)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rob Labruyère, PhD, Children's University Hospital Zurich
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MELMAC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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