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Clinical Trials/NCT03409978
NCT03409978CompletedNot Applicable

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

St. Olavs Hospital3 sites in 3 countries86 target enrollmentStarted: March 5, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
86
Locations
3
Primary Endpoint
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

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
12 Weeks to 17 Weeks (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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/

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
St. Olavs Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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