Cerebral PalsyNCT03409978
Smartphone App for Analysis of General Movements in Young Infants
An observational study of Cerebral Palsy, run by St. Olavs Hospital at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 weeks
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- in-Motion app
- Type of treatment
- Medical device
- How many people
- 86 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 5 Mar 2018to 20 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 weeks
- All sexes
- No healthy volunteers
- Child
Study population: High-risk infants included in the regular clinical follow-up program comprising a standard examination at 3 months corrected age.
Who may be able to join
- Infants referred to high-risk follow-up at the hospital
Who cannot join
- Unstable medical condition, progressive disorders, or diagnosis with a specific syndrome affecting motor development.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: 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.
- Conditions
- Cerebral Palsy
- Being tested
- in-Motion app
- Keywords
- Infants, newborn, General Movements, Video Recording, Mobile Applications, Prognosis, Parents
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-Motion appDevice
mobile phone application for recording fidgety movements at home
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: in-Motion app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of recordings that movement video recordings fulfil requirements needed for observation and classification of fidgety general movements
Measured: 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/
Measured: 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
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start5 Mar 2018
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, University of Illinois Chicago, Ann & Robert H Lurie Children's Hospital of Chicago, Christian Medical College, Vellore, India, University Ghent, Hillerod Hospital, Denmark
- Responsible party
- Sponsor
- Investigators
- Lars Adde, PhD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409978
- Sponsor's protocol ID
- 2017/913
- Status last verified
- Feb 2020
- First submitted
- 10 Jan 2018
- Last updated
- 19 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33664072
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Smartphone Application for Computer-based Movement Analysis During the Fidgety Period of General Movements
- ClinicalTrials.gov ID
- NCT03409978
- Acronym / sponsor ID
- 2017/913
- Conditions
- Cerebral Palsy
- Keywords
- Infants, newborn, General Movements, Video Recording, Mobile Applications, Prognosis, Parents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, University of Illinois Chicago, Ann & Robert H Lurie Children's Hospital of Chicago, Christian Medical College, Vellore, India, University Ghent, Hillerod Hospital, Denmark
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 25 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In-Motion app for movement analysis | – | Device: in-Motion appParticipants 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. |
Who may qualify
- Ages
- 12 to 17 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- High-risk infants included in the regular clinical follow-up program comprising a standard examination at 3 months corrected age.
Key inclusion criteria (1 listed)
- Infants referred to high-risk follow-up at the hospital
Key exclusion criteria (1 listed)
- Unstable medical condition, progressive disorders, or diagnosis with a specific syndrome affecting motor development.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| in-Motion appmobile phone application for recording fidgety movements at home | Device | In-Motion app for movement analysis |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Derived from this study: PubMed 33664072Adde 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Adde, PhD principal investigator
Norwegian University of Science and Technology
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by St. Olavs Hospital at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Denmark, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03409978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.