NCT06448065

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Apr 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Apr 2024Nov 2027

Study Start

First participant enrolled

April 20, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

June 7, 2024

Status Verified

May 1, 2024

Enrollment Period

3.4 years

First QC Date

June 3, 2024

Last Update Submit

June 3, 2024

Conditions

Keywords

cerebral palsygait pattern classification

Outcome Measures

Primary Outcomes (2)

  • Inter-rater reliability

    Assess inter-rater reliability between multiple raters assessing video recordings of gait in children with cerebral palsy

    approximately 12 months

  • Concurrent validity

    Assess concurrent validity between outcome classifications from video recordings and from three-dimensional gait kinematics children with cerebral palsy

    approximately 12 months

Study Arms (1)

Children and adults with cerebral palsy

Children and adults with cerebral palsy who attented the gait lab for a gait analysis are included in this study.

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Cecilia Lidbeck, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2024

First Posted

June 7, 2024

Study Start

April 20, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

June 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations