Early Remote At-risk Diagnosis for Cerebral Palsy in Follow-up Clinics for High-risk Infants

NCT04287166 | Active Not Recruiting

• 1 other identifier: REK 62240
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

Brief 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 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

Outcome Measures

Primary Outcomes (4)

• Scorable video for remote GMA

  1 week

• Correlation of computer software data between standard video set-up and handheld smartphone video.

  1 week

• Predictability of GMA and computer-based assessment for development of CP

  2 years

• Predictability of GMA and computer-based assessment for development of CP

  5 years

Eligibility Criteria

• Age: 0 Months - 2 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• Peripheral neuromotor disease e.g. brachial plexus injury
• iatrogenic restricted movements (e.g. cast for clubfoot)

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Alesund Hospital: collaborator
• Helse Nord-Trøndelag HF: collaborator

Study Sites (3)

Department of Pediatrics, Møre and Romsdal Hospital Trust

Ålesund, Norway

Location

Department of Pediatrics, Nord-Trøndelag Hospital Trust

Levanger, Norway

Location

Department of Pediatrics, St. Olav's Hospital Trust

Trondheim, Norway

Location

Related Publications (1)

• 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.

  PMID: 38987721 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Disease; Movement Disorders

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lise Støylen

  St Olavs Hospital, Clinic of Clinical Services

  STUDY DIRECTOR

• Torstein Rø IKOM

  Norwegian University of Science and Technology, IKOM

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 27, 2020
• Study Start: August 3, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (3)