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

NCT06090383 | Recruiting

• 1 other identifier: Sensor-H-22032100
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy (CP)

Keywords

Real-world; Movement Behavior; Adolescents; Cerebral Palsy; Wearables; Feasibility; Validity

Outcome Measures

Primary Outcomes (2)

• Gross Motor Functional Classification Scale - Expanded and revised (GMFCS-E&R)

  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

  Day one

• Jenkins Sleep Evaluation Questionnaire (JSEQ) - Danish version

  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).

  Day one

Study Arms (1)

Adolescents with CP and typically developed adolescents.

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic and community sample

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• University of Copenhagen: collaborator

Study Sites (1)

University Hospital Copenhagen, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (4)

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

  PMID: 26837375 BACKGROUND

• 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.

  PMID: 19391185 BACKGROUND

• 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.

  PMID: 35833425 BACKGROUND

• 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.

  PMID: 18834387 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jakob Lorentzen, Prof.

  University of Copenhagen, Department of Neuroscience

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ivana Bardino Novosel, Ph.d. student

CONTACT

+4527328961; ivana.novosel@sund.ku.dk

Jakob Lorentzen, Prof.

CONTACT

31521131; j.lorentzen@sund.ku.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 19, 2023
• Study Start: October 16, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

DK (1)