Cerebral PalsyIn-MotionNCT04287166
Early Remote At-risk Diagnosis for Cerebral Palsy in Follow-up Clinics for High-risk Infants
An observational study of Cerebral Palsy, run by St. Olavs Hospital at 3 sites in Norway.
Trial summary
Cerebral Palsy (CP) is the most common motor dysfunction in childhood. Traditionally, diagnosis is set between 12 and 24 months of age. This study will evaluate feasibility of a new screening procedure for early detection of CP in high-risk infants and investigate how such a procedure can be implemented in the Central… Read more about this study
- Who is it for?
- Ages 0 to 2 months
- Conditions the study is for
- Cerebral Palsy
- How many people
- 100 participants
- Where
- 3 sitesNorway
- Study dates
- 3 Aug 2020to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 2 months
- All sexes
- Child
Study population: High-risk infants referred to high-risk follow-up at discharge from one of the participating Neonatal Intensive Care Units, are candidates for enrollment. Following review of the inclusion and exclusion criteria, eligible subjects will be invited to participate. All subjects (parents) must give written informed consent prior to any study procedures being carried out.
Who may be able to join
- hospitalized at a Neonatal Intensive Care Unit (NICU) within the Central Norway Regional Health Authority that is referred to follow-up in the Specialist Health Services containing a team of minimum a pediatrician and a physiotherapist.
- at high-risk for adverse neurological outcomes as considered by the pediatrician on the basis of clinical judgement (example: serious asphyxia, prematurity, stroke, brain hemorrhage)
Who cannot join
- Peripheral neuromotor disease e.g. brachial plexus injury
- iatrogenic restricted movements (e.g. cast for clubfoot)
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Department of Pediatrics, Møre and Romsdal Hospital Trust
Ålesund
Department of Pediatrics, Nord-Trøndelag Hospital Trust
Levanger
Department of Pediatrics, St. Olav's Hospital Trust
Trondheim
About this study
Official title: Feasibility of Remote Early At-risk Diagnosis for Cerebral Palsy in High-risk Infant Follow-up Clinics in The Central Norway Regional Health Authority
Cerebral Palsy (CP) is the most common motor dysfunction in childhood. Traditionally, diagnosis is set between 12 and 24 months of age. This study will evaluate feasibility of a new screening procedure for early detection of CP in high-risk infants and investigate how such a procedure can be implemented in the Central Norwegian Regional Health Authority (CNRHA).
The most accurate method to detect and predict CP at an early age is the General Movement Assessment (GMA). GMA is based upon expert observations of infant spontaneous movements in a video. In Central-Norway such expertise is today only present at St. Olavs Hospital, Trondheim University Hospital. Video recordings by health personnel and parents will be used in follow-up programs within CNRHA for remote expert based GMA. In addition, machine learning models will be applied for automatic detection of CP.
Early identification of CP will lead to improved function and increased possibility to direct health care resources to the patients who need it most, independent of geographical and expert based constraints.
- Conditions
- Cerebral Palsy
- Keywords
- Diagnosis, Videos, Smartphone app, Movement, Movement disorders, Infants
- Medical subject headings
- Cerebral Palsy, Disease, Movement Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Scorable video for remote GMA
Measured: 1 week
Correlation of computer software data between standard video set-up and handheld smartphone video.
Measured: 1 week
Predictability of GMA and computer-based assessment for development of CP
Measured: 2 years
Predictability of GMA and computer-based assessment for development of CP
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start3 Aug 2020
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alesund Hospital, Helse Nord-Trøndelag HF
- Responsible party
- Sponsor
- Investigators
- Lise Støylen, Study director, St Olavs Hospital, Clinic of Clinical ServicesTorstein Rø IKOM, Study director, Norwegian University of Science and Technology, IKOM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287166
- Sponsor's protocol ID
- REK 62240
- Acronym
- In-Motion
- Status last verified
- Jul 2026
- First submitted
- 25 Feb 2020
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adde L, Aberg KB, Fjortoft T, Grunewaldt KH, Lade R, Osland S, Piegsa F, Sandstrom PG, Stoen R, Storvold GV, Eriksen BH. Implementation of remote general movement assessment using the in-motion instructions in a high-risk norwegian cohort. BMC Pediatr. 2024 Jul 10;24(1):442. doi: 10.1186/s12887-024-04927-4.
PubMed 38987721
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Remote Early At-risk Diagnosis for Cerebral Palsy in High-risk Infant Follow-up Clinics in The Central Norway Regional Health Authority
- ClinicalTrials.gov ID
- NCT04287166
- Acronym / sponsor ID
- In-Motion / REK 62240
- Conditions
- Cerebral Palsy
- Keywords
- Diagnosis, Videos, Smartphone app, Movement, Movement disorders, Infants
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Alesund Hospital, Helse Nord-Trøndelag HF
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 27 Feb 2020 (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.
Cerebral Palsy (CP) is the most common motor dysfunction in childhood. Traditionally, diagnosis is set between 12 and 24 months of age. This study will evaluate feasibility of a new screening procedure for early detection of CP in high-risk infants and investigate how such a procedure can be implemented in the Central Norwegian Regional Health Authority (CNRHA).
The most accurate method to detect and predict CP at an early age is the General Movement Assessment (GMA). GMA is based upon expert observations of infant spontaneous movements in a video. In Central-Norway such expertise is today only present at St. Olavs Hospital, Trondheim University Hospital. Video recordings by health personnel and parents will be used in follow-up programs within CNRHA for remote expert based GMA. In addition, machine learning models will be applied for automatic detection of CP.
Early identification of CP will lead to improved function and increased possibility to direct health care resources to the patients who need it most, independent of geographical and expert based constraints.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 2 months
- Sex
- All
- Age groups
- Child
- Study population
- High-risk infants referred to high-risk follow-up at discharge from one of the participating Neonatal Intensive Care Units, are candidates for enrollment. Following review of the inclusion and exclusion criteria, eligible subjects will be invited to participate. All subjects (parents) must give written informed consent prior to any study procedures being carried out.
Key inclusion criteria (2 listed)
- hospitalized at a Neonatal Intensive Care Unit (NICU) within the Central Norway Regional Health Authority that is referred to follow-up in the Specialist Health Services containing a team of minimum a pediatrician and a physiotherapist.
- at high-risk for adverse neurological outcomes as considered by the pediatrician on the basis of clinical judgement (example: serious asphyxia, prematurity, stroke, brain hemorrhage)
Key exclusion criteria (2 listed)
- Peripheral neuromotor disease e.g. brachial plexus injury
- iatrogenic restricted movements (e.g. cast for clubfoot)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Scorable video for remote GMA
Time frame: 1 week
Correlation of computer software data between standard video set-up and handheld smartphone video.
Time frame: 1 week
Predictability of GMA and computer-based assessment for development of CP
Time frame: 2 years
Predictability of GMA and computer-based assessment for development of CP
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Derived from this study: PubMed 38987721Adde L, Aberg KB, Fjortoft T, Grunewaldt KH, Lade R, Osland S, Piegsa F, Sandstrom PG, Stoen R, Storvold GV, Eriksen BH. Implementation of remote general movement assessment using the in-motion instructions in a high-risk norwegian cohort. BMC Pediatr. 2024 Jul 10;24(1):442. doi: 10.1186/s12887-024-04927-4.
- Individual participant dataSharing planned: No
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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.
Lise Støylen study director
St Olavs Hospital, Clinic of Clinical Services
Torstein Rø IKOM study director
Norwegian University of Science and Technology, IKOM
3 sites in 1 country: 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 Norway.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Scorable video for remote GMA (time frame: 1 week). The study lists 4 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 NCT04287166, 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 21 Jul 2026.