NCT06090383 Feasibility and Discriminant Validity of Monitoring Movement Behavior of Adolescents With Cerebral Palsy
| NCT ID | NCT06090383 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Cerebral Palsy (CP) |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2023-10-16 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2023-10-16 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A new artificial intelligence network has been developed to monitor real-world daytime and nighttime movement behavior of adolescents with cerebral palsy (CP). The network uses seven wearable sensors to recognize lying, sitting, and standing, as well as walking and movements of both arms and legs. This information can be useful for healthcare professionals to understand and influence change in movement behavior, leading to benefits for the health of adolescents with cerebral palsy. This study aims to examine the acceptability and technical dependability of monitoring the movement behavior of adolescents with cerebral palsy for 72 hours using wearable sensors. Additionally, the study aims to evaluate the network's ability to discriminate between control and individuals with CP, different subgroups of individuals with CP, as well as the incidence of sleep disturbance in the entire cohort.
Eligibility Criteria
Inclusion Criteria: * Clinical diagnosis of Cerebral Palsy at GMFCS-E\&R levels I-V and typically developed without neurological impairment. * Age range: 15-25 years * Capable of providing informed consent or have a legal guardian who can provide consent on their behalf. Exclusion Criteria: * Adolescents without the capacity to provide informed consent when another young adult with the capacity can provide the same or similar data. * Adolescents who have undergone musculoskeletal surgery or injury and have not resumed their normal movement behavior. * Presence of skin wounds in areas where sensors are to be attached.
Contact & Investigator
Jakob Lorentzen, Prof.
PRINCIPAL INVESTIGATOR
University of Copenhagen, Department of Neuroscience
Frequently Asked Questions
Who can join the NCT06090383 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 25 Years, studying Cerebral Palsy (CP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06090383 currently recruiting?
Yes, NCT06090383 is actively recruiting participants. Contact the research team at ivana.novosel@sund.ku.dk for enrollment information.
Where is the NCT06090383 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT06090383 clinical trial?
NCT06090383 is sponsored by Rigshospitalet, Denmark. The principal investigator is Jakob Lorentzen, Prof. at University of Copenhagen, Department of Neuroscience. The trial plans to enroll 25 participants.
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