- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03409978
Smartphone App for Analysis of General Movements in Young Infants
February 18, 2020 updated by: St. Olavs Hospital
Feasibility of a Smartphone Application for Computer-based Movement Analysis During the Fidgety Period of General Movements
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 Overview
Study Type
Observational
Enrollment (Actual)
86
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 3 months (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
High-risk infants included in the regular clinical follow-up program comprising a standard examination at 3 months corrected age.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
mobile phone application for recording fidgety movements at home
|
What is the study measuring?
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
Time Frame: 17 weeks post term age
|
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
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/
|
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
Time Frame: 17 weeks
|
17 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lars Adde, PhD, Norwegian University of Science and Technology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 5, 2018
Primary Completion (ACTUAL)
December 20, 2019
Study Completion (ACTUAL)
December 20, 2019
Study Registration Dates
First Submitted
January 10, 2018
First Submitted That Met QC Criteria
January 17, 2018
First Posted (ACTUAL)
January 25, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 19, 2020
Last Update Submitted That Met QC Criteria
February 18, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/913
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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