Clinical trial NCT06448065: Gait Classification in Children With Cerebral Palsy, a Reliability Study
Official title: A Reliability Study of Gait Classification in Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Cerebral Palsy
Keywords: cerebral palsy
gait pattern classification
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska University Hospital
name: Karolinska Institutet
First posted: 2024-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population from which the study participants are recruited are ambulatory children and young adults with cerebral palsy. All individuals with cerebral palsy that visited the gait lab over the past 20 years are eligible to be included in the current study.

Brief summary: The goal of this observational study is to assess whether gait classification patterns can be reliably obtained from video recordings in comparison with three-dimensional kinematic data.

The main questions it aims to answer are:

Are gait classifications from video recordings reliable between raters? Are gait classifications from video recordings valid in comparison with three-dimensional kinematic data?

Gait analysis data from participants who visited the gait lab in the Karolinska Hospital will be used for this purpose.

Detailed description: Current retrospective observational study aims to assess the reliability and validity of gait pattern classification systems in ambulatory children with CP. Gait classification is often performed using kinematic gait data obtained via a three dimensional (3D) data captured in a specialized gait lab using infra-red cameras. However, not all hospitals and clinical centers have access to such a specialized gait lab, and therefore often use video recordings as an alternative for gait classification. It is currently not known whether such a classification based on solely video recordings is equally reliable in comparison with kinematic gait data. For this purpose, current study aims to assess the reliability and validity of video recordings to classify children with CP according to predefined gait classifications. Sagittal plane video recordings during barefoot walking in children with CP will be used to classify the study participants into seven different gait classification patterns. For reliability, inter-rater reliability between raters scoring the video recordings will be assessed. To evaluate whether video recordings could serve as a valid alternative for kinematic gait data, the agreement between the classifications from the video recordings and the kinematic data additionally will be assessed.

Eligibility criteria: Inclusion Criteria:

* Main diagnosis of spastic cerebral palsy
* Age 3 to 18 at the time of gait analysis
* Availability of barefoot walking data collected at the Karolinska Hospital gait lab
* Written informed consent of both parents to use the clinically collected data as research data

Exclusion Criteria:

* Main diagnosis of dyskinetic or ataxic cerebral palsy
* No barefoot walking trials available
* No kinematic data available
* BTX-A injections 6 months prior to gait analysis
* Orthopaedic surgery one year prior to gait analysis

Primary outcomes:
measure: Inter-rater reliability
timeFrame: approximately 12 months
measure: Concurrent validity
timeFrame: approximately 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Cecilia Lidbeck, PhD
role: PRINCIPAL_INVESTIGATOR
References: