Clinical trial NCT03409978: Smartphone App for Analysis of General Movements in Young Infants
Official title: Feasibility of a Smartphone Application for Computer-based Movement Analysis During the Fidgety Period of General Movements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: Infants, newborn
General Movements
Video Recording
Mobile Applications
Prognosis
Parents
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
name: University of Illinois at Chicago
name: Ann & Robert H Lurie Children's Hospital of Chicago
name: Christian Medical College, Vellore, India
name: University Ghent
name: Hillerod Hospital, Denmark
First posted: 2018-01-25
Enrollment: 86
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High-risk infants included in the regular clinical follow-up program comprising a standard examination at 3 months corrected age.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of recordings that movement video recordings fulfil requirements needed for observation and classification of fidgety general movements
timeFrame: 17 weeks post term age
measure: 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
timeFrame: 2 weeks after received video recordings
measure: Correlation between computer-based software estimates by smartphone videos performed by parents at home and standard videos performed at the hospital follow-up clinic
timeFrame: 17 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
city: Copenhagen
country: Denmark
facility: Hillerød Hospital
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Lars Adde, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adde L, Brown A, van den Broeck C, DeCoen K, Eriksen BH, Fjortoft T, Groos D, Ihlen EAF, Osland S, Pascal A, Paulsen H, Skog OM, Sivertsen W, Stoen R. In-Motion-App for remote General Movement Assessment: a multi-site observational study. BMJ Open. 2021 Mar 4;11(3):e042147. doi: 10.1136/bmjopen-2020-042147.