NCT03409978

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 25, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

March 5, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

January 10, 2018

Last Update Submit

February 18, 2020

Conditions

Cerebral Palsy

Keywords

Infants, newbornGeneral MovementsVideo RecordingMobile ApplicationsPrognosisParents

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

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.

Device: in-Motion app

Interventions

in-Motion appDEVICE

mobile phone application for recording fidgety movements at home

In-Motion app for movement analysis

Eligibility Criteria

Age12 Weeks - 17 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

High-risk infants included in the regular clinical follow-up program comprising a standard examination at 3 months corrected age.

You may qualify if:

  • Infants referred to high-risk follow-up at the hospital

You may not qualify if:

  • Unstable medical condition, progressive disorders, or diagnosis with a specific syndrome affecting motor development.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ghent University

Ghent, Belgium

Location

Hillerød Hospital

Copenhagen, Denmark

Location

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (1)

  • 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.

    PMID: 33664072DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Lars Adde, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 25, 2018

Study Start

March 5, 2018

Primary Completion

December 20, 2019

Study Completion

December 20, 2019

Last Updated

February 19, 2020

Record last verified: 2020-02

Locations

NO(1)BE(1)DK(1)