Cerebral PalsyGCPNCT06448065
Gait Classification in Children With Cerebral Palsy, a Reliability Study
An observational study of Cerebral Palsy, run by Region Stockholm at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 20 Apr 2024to 30 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Reliability Study of Gait Classification in Children With Cerebral Palsy
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, gait pattern classification
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-rater reliability
Assess inter-rater reliability between multiple raters assessing video recordings of gait in children with cerebral palsy
Measured: approximately 12 months
Concurrent validity
Assess concurrent validity between outcome classifications from video recordings and from three-dimensional gait kinematics children with cerebral palsy
Measured: approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start20 Apr 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska University Hospital, Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Cecilia Lidbeck, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448065
- Sponsor's protocol ID
- K00005123
- Acronym
- GCP
- Status last verified
- May 2024
- First submitted
- 3 Jun 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Reliability Study of Gait Classification in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06448065
- Acronym / sponsor ID
- GCP / K00005123
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, gait pattern classification
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska University Hospital, Karolinska Institutet
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inter-rater reliability
Time frame: approximately 12 months
Assess inter-rater reliability between multiple raters assessing video recordings of gait in children with cerebral palsy
Concurrent validity
Time frame: approximately 12 months
Assess concurrent validity between outcome classifications from video recordings and from three-dimensional gait kinematics children with cerebral palsy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cecilia Lidbeck, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-rater reliability (time frame: approximately 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024; AzTrials last refreshed its copy on 30 Oct 2026.