Monitoring Everyday Life Motor Activity in Children

Neurologic Disorders Clinical Trial

— MELMAC  

Official title:

Monitoring Everyday Life Motor Activity in Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02236091
• Other study ID #: MELMAC
• Status: Terminated
• Start date: October 2014
• Est. completion date: August 21, 2018

Study information

• Verified date: October 2018
• Source: University Children's Hospital, Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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).

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurologic Disorders

Locations

Country	Name	City	State
Switzerland	Rehabilitation Center of the Children's University Hospital	Affoltern am Albis

Sponsors (1)

Lead Sponsor	Collaborator
Rob Labruyere

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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

Outcome

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)