<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02236091</url>
  </required_header>
  <id_info>
    <org_study_id>MELMAC</org_study_id>
    <nct_id>NCT02236091</nct_id>
  </id_info>
  <brief_title>Monitoring Everyday Life Motor Activity in Children</brief_title>
  <acronym>MELMAC</acronym>
  <official_title>Monitoring Everyday Life Motor Activity in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rob Labruyere</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Children's Hospital, Zurich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall aim of this project is to monitor everyday life activity of children with&#xD;
      neurological disorders undergoing rehabilitation using wearable sensors capable of accurate&#xD;
      and unobtrusive long-term measurement.&#xD;
&#xD;
      Specific objectives:&#xD;
&#xD;
        1. To adapt the sensors for the use by children with neurological disorders. The focus lies&#xD;
           on the exact positioning and the investigation of the needed amount of IMUs.&#xD;
&#xD;
        2. To validate the sensor data with collected video recordings and to develop specific&#xD;
           algorithms to automatically extract specific movements and to analyze long-term sensor&#xD;
           recordings.&#xD;
&#xD;
        3. To perform a cross-sectional study to assess intensity, task-specificity and duration of&#xD;
           upper and lower limb activity during rehabilitation. There, we aim to gain objective&#xD;
           information about levels and types of activity during rehabilitation in relation to age,&#xD;
           gender and disorder.&#xD;
&#xD;
        4. To conduct a responsiveness study to assess whether or not the sensor output is able to&#xD;
           highlight changes over time during rehabilitation.&#xD;
&#xD;
      Therefore, at time point T=0 (shortly after admission to our center), participants are&#xD;
      equipped with 3 inertial measurement units (1 at each wrist and 1 at the sternum).&#xD;
      Additionally, a small wearable camera is mounted to the chest. The participants then return&#xD;
      to their everyday life for 4 hours (no therapies, measurement period is in the evening).&#xD;
      Afterwards, the equipment is removed again. To investigate responsiveness, the same protocol&#xD;
      is being repeated 4 weeks later (time point T=1).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lacking algorithms led to abortion of project&#xD;
  </why_stopped>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">August 21, 2018</completion_date>
  <primary_completion_date type="Actual">July 14, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Counts per minute at time point T=0</measure>
    <time_frame>At T=0</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Counts per minute at time point T=1</measure>
    <time_frame>At T=1 (4 weeks after T=0)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Motor assessment: Melbourne 2 at time point T=0</measure>
    <time_frame>At T=0</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent questionnaire: Abilhand-Kids at time point T=0</measure>
    <time_frame>At T=0</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor assessment: Melbourne 2 at time point T=1</measure>
    <time_frame>At T=1 (4 weeks after T=0)</time_frame>
    <description>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.&#xD;
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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent questionnaire: Abilhand-Kids at time point T=1</measure>
    <time_frame>At T=1 (4 weeks after T=0)</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Neurologic Disorders</condition>
  <arm_group>
    <arm_group_label>Inpatients</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be inpatients from our rehabilitation center and will be recruited directly&#xD;
        by researchers working on this project&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Various neuro-orthopedic diagnoses. Broad inclusion criteria are required to better&#xD;
             generalize study results to the patient population of our center.&#xD;
&#xD;
          -  Both walking or in wheelchair, but mobility independent from assisting people&#xD;
&#xD;
          -  Cognitive ability to be able to follow simple verbal instructions.&#xD;
&#xD;
          -  Signed informed consent from legal guardians and also from adolescents aged 15 years&#xD;
             or older before study onset.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rob Labruyère, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's University Hospital Zurich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rehabilitation Center of the Children's University Hospital</name>
      <address>
        <city>Affoltern am Albis</city>
        <zip>8910</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <reference>
    <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.</citation>
    <PMID>23899401</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Children's Hospital, Zurich</investigator_affiliation>
    <investigator_full_name>Rob Labruyere</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>cerebral palsy</keyword>
  <keyword>stroke</keyword>
  <keyword>traumatic brain injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nervous System Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02236091
org study id: MELMAC
nct id: NCT02236091
lead sponsor: 
has dmc: Yes
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).
observational model: Case-Only
time perspective: Cross-Sectional
measure: Counts per minute at time point T=0
time frame: At T=0
description: 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.
measure: Counts per minute at time point T=1
time frame: At T=1 (4 weeks after T=0)
description: 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.
measure: Motor assessment: Melbourne 2 at time point T=0
time frame: At T=0
description: 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.
measure: Parent questionnaire: Abilhand-Kids at time point T=0
time frame: At T=0
description: 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.
measure: Motor assessment: Melbourne 2 at time point T=1
time frame: At T=1 (4 weeks after T=0)
description: 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.
measure: Parent questionnaire: Abilhand-Kids at time point T=1
time frame: At T=1 (4 weeks after T=0)
description: 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.
arm group label: Inpatients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: No
last name: Rob Labruyère, PhD
role: Principal Investigator
affiliation: Children's University Hospital Zurich
facility: 
country: Switzerland
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.
PMID: 23899401
responsible party type: Sponsor-Investigator
investigator affiliation: University Children's Hospital, Zurich
investigator full name: Rob Labruyere
investigator title: PhD
mesh term: Nervous System Diseases