Smartphone App for Analysis of General Movements in Young Infants

Study Overview
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Brief Summary
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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.

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

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Device: in-Motion app


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Weeks
Maximum Age: 17 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| In-Motion app for movement analysis<br>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. | Device: in-Motion app<br>* mobile phone application for recording fidgety movements at home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of recordings that movement video recordings fulfil requirements needed for observation and classification of fidgety general movements |  | 17 weeks post term age | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parents, Infants, newborn, General Movements, Video Recording, Mobile Applications, Prognosis