Neurologic DisordersMELMACNCT02236091
Monitoring Everyday Life Motor Activity in Children
An observational study of Neurologic Disorders, run by Rob Labruyere at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Neurologic Disorders
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2014to 21 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients will be inpatients from our rehabilitation center and will be recruited directly by researchers working on this project
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Rehabilitation Center of the Children's University Hospital
Affoltern am Albis, 8910
About this study
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:
Read more
- 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).
- Conditions
- Neurologic Disorders
- Keywords
- cerebral palsy, stroke, traumatic brain injury
- Medical subject headings
- Nervous System Diseases, Cerebral Palsy, Stroke, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inpatients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At T=0
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.
Measured: At T=1 (4 weeks after T=0)
Secondary outcomes (4)
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.
Measured: At T=0
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.
Measured: At T=0
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.
Measured: At T=1 (4 weeks after T=0)
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.
Measured: At T=1 (4 weeks after T=0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startOct 2014
- Primary completion14 Jul 2016
- Study completion21 Aug 2018
Why it stopped: Lacking algorithms led to abortion of project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurologic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rob Labruyere
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rob Labruyere, University Children's Hospital, Zurich
- Investigators
- Rob Labruyère, PhD, Principal investigator, Children's University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236091
- Sponsor's protocol ID
- MELMAC
- Acronym
- MELMAC
- Status last verified
- Oct 2018
- First submitted
- 1 Sep 2014
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23899401
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Everyday Life Motor Activity in Children
- ClinicalTrials.gov ID
- NCT02236091
- Acronym / sponsor ID
- MELMAC / MELMAC
- Conditions
- Neurologic Disorders
- Keywords
- cerebral palsy, stroke, traumatic brain injury
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lacking algorithms led to abortion of project
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rob LabruyereUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- 14 Jul 2016 (actual)
- Study completion
- 21 Aug 2018 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inpatients | – | – |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients will be inpatients from our rehabilitation center and will be recruited directly by researchers working on this project
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Counts per minute at time point T=0
Time frame: At 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.
Counts per minute at time point T=1
Time frame: At 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.
4 secondary outcomes
Motor assessment: Melbourne 2 at time point T=0
Time frame: At T=0
Parent questionnaire: Abilhand-Kids at time point T=0
Time frame: At T=0
Motor assessment: Melbourne 2 at time point T=1
Time frame: At T=1 (4 weeks after T=0)
Parent questionnaire: Abilhand-Kids at time point T=1
Time frame: At T=1 (4 weeks after T=0)
Results and safety
The study was stopped early (reason given: Lacking algorithms led to abortion of project). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Background: PubMed 23899401Strohrmann 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob Labruyère, PhD principal investigator
Children's University Hospital Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurologic Disorders, run by Rob Labruyere at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lacking algorithms led to abortion of project). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Counts per minute at time point T=0 (time frame: At T=0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02236091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.