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

NCT ID: NCT06090383

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2025-12-31

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.

Detailed Description

Cerebral palsy (CP) is a non-progressive disorder resulting from injuries or abnormalities in fetal or early infant brain development. According to registries from European countries, the condition affects 2-3 out of every 1000 live births. An individual with CP typically presents with motor development disorders that cause abnormal patterns of movement and posture due to impaired coordination of movements and muscle tone regulation. People with cerebral palsy can also have various other problems, including sensory and cognitive problems and sleep disturbances. These symptoms result in limitations in activity level and societal participation throughout the individual's life. Adolescents and even children as young as seven may experience a decline in motor ability, leading to changes in their movement behavior. Healthcare professionals rely on various observations and measurements performed in clinical and hospital settings to assess and treat individuals with CP. However, there is some uncertainty about whether these assessments truly reflect real-life movement behaviors, as using an impaired extremity in everyday life frequently deviates from its motor capacity. There is an absence of robust tools that capture daytime and nighttime movement behavior in real-world settings rather than in clinical or controlled environments. Hemiparesis is the most common marker of CP, making asymmetrical deficits a target for intensive interventions such as physical and occupational therapy. Yet, no clinical tools are available that document asymmetrical differences in the real world in children and adolescents with CP. An objective method to measure real-world movement patterns would allow therapists to identify individuals who need a more comprehensive evaluation and to target interventions and other management strategies more precisely. This would help children and adolescents with CP gain motor skills to maximize independence. Further, objectively observing individuals with CP in their daily lives is essential to gain insights into functional decline. It has been observed that children and adolescents with CP are more likely to experience sleep-related difficulties such as difficulty initiating sleep, frequent nocturnal awakenings, discomfort while in bed, and early morning awakenings. As sleep quality plays a vital role in health-related quality of life, it is crucial to have objective methods to evaluate and monitor potential sleep problems in a real-world context.

A deep-learning convolutional neural network has been modeled to recognize postures lying, sitting, and standing the activity of walking, and movements of the right and left extremities. The network uses accelerometer and gyroscope data from 7 wearable sensors. Testing of the network´s performance found that it surpasses human annotators in accurately classifying the movement behavior of healthy and typically developed adults. These findings are currently under review and have yet to be published. The present protocol details the methodology for assessing the feasibility of real-world movement behavior monitoring and the discriminant validity of the network in adolescents with CP and controls.

The feasibility evaluation examines the technology used, e.g., potential data loss and the credibility of data output, as well as user acceptance, e.g., sensor wear time and adverse events. The networks' discriminant ability will be assessed by the network's ability to differentiate between controls and CP severity, e.g., scores on the Gross Motor Functional Classification Scale - Expanded and revised (GMFCS-E&R), different types of CP, differently affected body parts of the participating adolescents with CP, as well as individuals who have and have not sleep problems in the entire cohort.

Conditions

Cerebral Palsy (CP)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adolescents with CP and typically developed adolescents.

No interventions assigned to this group

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Jan Christensen

Senior researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jakob Lorentzen, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen, Department of Neuroscience

Locations

University Hospital Copenhagen, Rigshospitalet

Copenhagen, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Ivana Bardino Novosel, Ph.d. student

Role: CONTACT

ivana.novosel@sund.ku.dk

+4527328961

Jakob Lorentzen, Prof.

Role: CONTACT

j.lorentzen@sund.ku.dk

31521131

Facility Contacts

Ivana Bardino Novosel, PhD. student

Role: primary

ivana.novosel@sund.ku.dk

+4527328961

Jakob Lorentzen

Role: backup

j.lorentzen@sund.ku.dk

31521131

References

Wimalasundera N, Stevenson VL. Cerebral palsy. Pract Neurol. 2016 Jun;16(3):184-94. doi: 10.1136/practneurol-2015-001184. Epub 2016 Feb 2.

Reference Type: BACKGROUND

PMID: 26837375 (View on PubMed)

Hanna SE, Rosenbaum PL, Bartlett DJ, Palisano RJ, Walter SD, Avery L, Russell DJ. Stability and decline in gross motor function among children and youth with cerebral palsy aged 2 to 21 years. Dev Med Child Neurol. 2009 Apr;51(4):295-302. doi: 10.1111/j.1469-8749.2008.03196.x.

Reference Type: BACKGROUND

PMID: 19391185 (View on PubMed)

Hulst RY, Gorter JW, Obeid J, Voorman JM, van Rijssen IM, Gerritsen A, Visser-Meily JMA, Pillen S, Verschuren O. Accelerometer-measured physical activity, sedentary behavior, and sleep in children with cerebral palsy and their adherence to the 24-hour activity guidelines. Dev Med Child Neurol. 2023 Mar;65(3):393-405. doi: 10.1111/dmcn.15338. Epub 2022 Jul 14.

Reference Type: BACKGROUND

PMID: 35833425 (View on PubMed)

Palisano RJ, Rosenbaum P, Bartlett D, Livingston MH. Content validity of the expanded and revised Gross Motor Function Classification System. Dev Med Child Neurol. 2008 Oct;50(10):744-50. doi: 10.1111/j.1469-8749.2008.03089.x.

Reference Type: BACKGROUND

PMID: 18834387 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Sensor-H-22032100

Identifier Type: -

Identifier Source: org_study_id