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Clinical Trials in Denmark / NCT06090383
Recruiting Observational

Feasibility and Discriminant Validity of Monitoring Movement Behavior of Adolescents With Cerebral Palsy

NCT06090383 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Observational
Started
2023-10-16
Last updated
2025-06-22

Condition(s) studied

Cerebral Palsy (CP)

Study 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

Sex
ALL
Min age
15 Years
Max age
25 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Gross Motor Functional Classification Scale - Expanded and revised (GMFCS-E&R) — Day one
    The GMFCS-E\&R is a classification system comprising five levels that aims to describe the gross motor function of children and adolescents with CP. This system considers five age bands; in this case, we use the 12-18-year-old age band. Individuals with CP are classified as level I when capable of walking without limitations, while those with non-ambulatory functions are classified as levels IV and V
  • Jenkins Sleep Evaluation Questionnaire (JSEQ) - Danish version — Day one
    The JSEQ evaluates the frequency and intensity of sleep difficulties in the past month. The questions pertain to difficulty falling asleep, frequent awakenings during the night, trouble remaining asleep, and subjective feelings of fatigue and sleepiness despite a typical night's rest. Respondents rate their experiences using a Likert-type scale, with the following response alternatives: not at all (1), 1 to 3 days (2), 4 to 7 days (3), 8 to 14 days (4), 15 to 21 days (5), and 22 to 28 days (6).

Trial sites (1)

FacilityCityRegionStatus
University Hospital Copenhagen, Rigshospitalet Copenhagen Denmark Recruiting

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Other trials for the same condition

Monitoring Fatigue In Daily Life In Adults With Cerebral Palsy or Acquired Brain Injury Recruiting
Whole Body Metabolism in Children With Cerebral Palsy With Low Skeletal Muscle Mass Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06090383 on ClinicalTrials.gov ↗ ← All trials in Denmark