Smartphone App for Analysis of General Movements in Young Infants

NCT ID: NCT03409978

Last Updated: 2020-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-05

Study Completion Date

2019-12-20

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.

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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In-Motion app for movement analysis

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.

in-Motion app

Intervention Type DEVICE

mobile phone application for recording fidgety movements at home

Interventions

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in-Motion app

mobile phone application for recording fidgety movements at home

Intervention Type DEVICE

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.
Minimum Eligible Age

12 Weeks

Maximum Eligible Age

17 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role collaborator

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role collaborator

Christian Medical College, Vellore, India

OTHER

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role collaborator

Hillerod Hospital, Denmark

OTHER

Sponsor Role collaborator

St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars Adde, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

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Ghent University

Ghent, , Belgium

Site Status

Hillerød Hospital

Copenhagen, , Denmark

Site Status

St Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Belgium Denmark Norway

References

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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.

Reference Type DERIVED
PMID: 33664072 (View on PubMed)

Other Identifiers

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2017/913

Identifier Type: -

Identifier Source: org_study_id

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