NCT02236091

Brief 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. 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. 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. 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. 4.To conduct a responsiveness study to assess whether or not the sensor output is able to highlight changes over time during rehabilitation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
21 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2016

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 21, 2018

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

1.8 years

First QC Date

September 1, 2014

Last Update Submit

October 15, 2018

Conditions

Neurologic Disorders

Keywords

cerebral palsystroketraumatic brain injury

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Motor assessment: Melbourne 2 at time point T=0

    At T=0

  • Parent questionnaire: Abilhand-Kids at time point T=0

    At T=0

  • Motor assessment: Melbourne 2 at time point T=1

    At T=1 (4 weeks after T=0)

  • Parent questionnaire: Abilhand-Kids at time point T=1

    At T=1 (4 weeks after T=0)

Study Arms (1)

Inpatients

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients will be inpatients from our rehabilitation center and will be recruited directly by researchers working on this project

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Center of the Children's University Hospital

Affoltern am Albis, 8910, Switzerland

Location

Related Publications (1)

  • 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: 23899401BACKGROUND

MeSH Terms

Conditions

Nervous System DiseasesCerebral PalsyStrokeBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Rob Labruyère, PhD

    Children's University Hospital Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 1, 2014

First Posted

September 10, 2014

Study Start

October 1, 2014

Primary Completion

July 14, 2016

Study Completion

August 21, 2018

Last Updated

October 17, 2018

Record last verified: 2018-10

Locations

CH(1)