Gait Classification in Children With Cerebral Palsy, a Reliability Study

Cerebral Palsy Clinical Trial

— GCP  

Official title:

A Reliability Study of Gait Classification in Children With Cerebral Palsy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06448065
• Other study ID #: K00005123
• Status: Enrolling by invitation
• Start date: April 20, 2024
• Est. completion date: November 30, 2027

Study information

• Verified date: May 2024
• Source: Region Stockholm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: November 30, 2027
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Region Stockholm	Karolinska Institutet, Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter-rater reliability	Assess inter-rater reliability between multiple raters assessing video recordings of gait in children with cerebral palsy	approximately 12 months
Primary	Concurrent validity	Assess concurrent validity between outcome classifications from video recordings and from three-dimensional gait kinematics children with cerebral palsy	approximately 12 months