Smartphone App for Analysis of General Movements in Young Infants

Completed

• Conditions: Cerebral Palsy
• Interventions: Device: in-Motion app

• Registration Number: NCT03409978
• Lead Sponsor: St. Olavs Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-25
• Study Start: 2018-03-05
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
In-Motion app for movement analysis	in-Motion app	Participants will be recruited from infants referred to the high-risk follow-up clinic at the hospital. These at-risk children are included in the regular clinical follow-up program comprising a standard examination at 3 months corrected age (fidgety general movements period). Infant/families from St. Olavs Hospital (n= 15), in Norway, Lurie Children's Hospital (n=15), Chicago, USA, Christian Medical College (n=15), Vellore, India, University of Ghent (n=15), Belgium, and Hillerød Hospital (n=30), Copenhagen, Denmark will be invited to participate.

Primary Outcome Measures

Name	Time	Method
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	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/
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
Percentage of recordings that movement video recordings fulfil requirements needed for observation and classification of fidgety general movements	17 weeks post term age

Trial Locations

Locations (3)

St Olavs Hospital; 🇳🇴 Trondheim, Norway

Ghent University; 🇧🇪 Ghent, Belgium

Hillerød Hospital; 🇩🇰 Copenhagen, Denmark