Skip to main content
OpenTrials
Completed

NCT Number: NCT03409978

Smartphone App for Analysis of General Movements in Young Infants

Analysis of spontaneous movements in young infants from video recordings is recommended as an early medical assessment tool for prediction of cerebral palsy in high-risk infants. Such video recording have previously been performed in follow-up programs at hospitals using semi standardized video set-ups. The research group behind this study develops a smart-phone application that makes it possible for parents to video film their infant spontaneous movements at home, upload and send the video for analysis at the hospital provided by experts. The objectives of the study are to assess the feasibility of the In-Motion app for video recording of infant spontaneous movements, upload and send the video to St. Olavs Hospital in Trondheim, Norway, for assessment, and how parents experience this. 90-120 high-risk infants from Norway, Denmark, Belgium, USA, Great Britain and India will participate. Parents will record their infant spontaneous movements and answer questionnaires. Video quality will be evaluated by experts within the field and their use for computer-based assessment will be evaluated.

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 week–17 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Ghent University, Ghent, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants referred to high-risk follow-up at the hospital

Exclusion criteria

  • Unstable medical condition, progressive disorders, or diagnosis with a specific syndrome affecting motor development.

Treatment and study plan

in-Motion app

Device

mobile phone application for recording fidgety movements at home

Primary outcomes

  1. Percentage of recordings that movement video recordings fulfil requirements needed for observation and classification of fidgety general movements

    Time frame: 17 weeks post term age

  2. Ease of use of the In-Motion App in score on the Software usability scale (SUS) as part of a questionnaire sent to users two weeks after received video recordings

    Time frame: 2 weeks after received video recordings

    SUS is a 10 item questionnaire with 5 response options between 'strongly disagree' and 'strongly agree'. All values are scaled from 0 to 4 (with four being the most positive response). The range of possible values is converted from 0 to 100. A SUS score above a 68 would be considered above average. See https://measuringu.com/sus/

  3. Correlation between computer-based software estimates by smartphone videos performed by parents at home and standard videos performed at the hospital follow-up clinic

    Time frame: 17 weeks

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Christian Medical College, Vellore, India
  • Hillerod Hospital, Denmark
  • Norwegian University of Science and Technology
  • University Ghent
  • University of Illinois at Chicago

Registry information

Official study title

Feasibility of a Smartphone Application for Computer-based Movement Analysis During the Fidgety Period of General Movements

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 25, 2018
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.