Smartphone App for Analysis of General Movements in Young Infants

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03409978
• Other study ID #: 2017/913
• Status: Completed
• Start date: March 5, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: February 2020
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Weeks to 17 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• in-Motion app
mobile phone application for recording fidgety movements at home

Locations

Country	Name	City	State
Belgium	Ghent University	Ghent
Denmark	Hillerød Hospital	Copenhagen
Norway	St Olavs Hospital	Trondheim

Sponsors (7)

Lead Sponsor	Collaborator
St. Olavs Hospital	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

Countries where clinical trial is conducted

Belgium,  Denmark,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of recordings that movement video recordings fulfil requirements needed for observation and classification of fidgety general movements		17 weeks post term age
Primary	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	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/	2 weeks after received video recordings
Primary	Correlation between computer-based software estimates by smartphone videos performed by parents at home and standard videos performed at the hospital follow-up clinic		17 weeks