Cerebral PalsyNCT06505499
Gait Profile Score in Children With Cerebral Palsy (CP): Influence of the CP Type, Treatment With Botulinum Injection and Multilevel Surgery
An observational study of Cerebral Palsy and Gait Disorders in Children, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Instrumented three dimensional gait analysis (3DGA) permits to record spatial, temporal, kinetics, kinematics and electromyographic (EMG) parameters in order to understand gait impairment in children and teenagers with cerebral palsy (CP). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy, Gait Disorders in Children
- What is being tested?
- Gait Profile Score and Gait Visual Score
- How many people
- 51 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2024to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents with cerebral palsy treated at the Saint-Etienne University Hospital will be included.
Who may be able to join
- Etiology of cerebral palsy
- Unilateral, bilateral, triplegic or quadriplegic forms of cerebral palsy.
- 6 to 18 years old
- GMFCS (Gross Motor Function Classification System) I to III
- Instrumented gait analysis of the laboratory of St-Etienne
- Absence of botulinum toxin injection or serial casting in the three months after a first instrumented gait analysis.
Who cannot join
- Etiology others than cerebral palsy as defined classically (ex: ischemic infarcts in a child older than two years).
- Previous surgery in lower-limb.
Trial locations and contacts
1 site in 1 country.
About this study
Instrumented three dimensional gait analysis (3DGA) permits to record spatial, temporal, kinetics, kinematics and electromyographic (EMG) parameters in order to understand gait impairment in children and teenagers with cerebral palsy (CP). Nowadays, single-event multilevel surgery in subjects with CP cannot be performed without 3DGA. However, interpretation of multiple and interdependent data remains complex for the clinician. To address this issue, gait statistical index have been developed to give a single measure of the quality of the gait pattern. Among actual index, the Gait Profile Score (GPS), developed by Baker et al (2009), measure the deviation of kinematics parameters from a controlled dataset. The GPS can be divided in nine Gait Variable Score (GVS), corresponding to major lower limb joints: the MAP (Movement Analysis Profile). Many studies have reported the interest of the GPS to analysis gait of subjects with CP: good inter-session reliability, predictor of postoperative kinematic improvement, minimal clinical threshold calculated at 1.6°, significant relationship with clinical data (joint contractures), and sensibility to change after a single-event multilevel surgery.
- Conditions
- Cerebral Palsy, Gait Disorders in Children
- Being tested
- Gait Profile Score, Gait Visual Score
- Keywords
- Cerebral palsy, Gait profile score, Botulinum toxin injection, Multilevel surgery
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait Profile ScoreOther
Gait Profile Score in degrees, calculated from kinematic raw data with the Gdi_GPS_calculator spreadsheet developed by Baker (2009).
Gait Visual ScoreOther
Gait Visual Score in degrees, calculated from kinematic raw data with the Gdi_GPS_calculator spreadsheet developed by Baker (2009)
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL GROUP | Children and teenagers with CP with an instrumented gait analysis performed since 2019. Receives: Other: Gait Profile Score; Other: Gait Visual Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degrees of Gait Profile Score overall
Analyze Degrees of Gait Profile Score overall
Measured: Day 1
Secondary outcomes (2)
Gait Profile Score right
Analyze Gait Profile Score right.
Measured: Month 2
Gait Profile Score left
Analyze Gait Profile Score left.
Measured: Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start6 Mar 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
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.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- 51 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clément BOULARD, physiotherapist, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505499
- Sponsor's protocol ID
- IRBN402024/CHUSTE
- Status last verified
- Jan 2025
- First submitted
- 11 Jul 2024
- Last updated
- 10 Jan 2025
- 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 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Profile Score in Children With Cerebral Palsy (CP): Influence of the CP Type, Treatment With Botulinum Injection and Multilevel Surgery
- ClinicalTrials.gov ID
- NCT06505499
- Acronym / sponsor ID
- IRBN402024/CHUSTE
- Conditions
- Cerebral Palsy, Gait Disorders in Children
- Keywords
- Cerebral palsy, Gait profile score, Botulinum toxin injection, Multilevel surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 17 Jul 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.
Instrumented three dimensional gait analysis (3DGA) permits to record spatial, temporal, kinetics, kinematics and electromyographic (EMG) parameters in order to understand gait impairment in children and teenagers with cerebral palsy (CP). Nowadays, single-event multilevel surgery in subjects with CP cannot be performed without 3DGA. However, interpretation of multiple and interdependent data remains complex for the clinician. To address this issue, gait statistical index have been developed to give a single measure of the quality of the gait pattern. Among actual index, the Gait Profile Score (GPS), developed by Baker et al (2009), measure the deviation of kinematics parameters from a controlled dataset. The GPS can be divided in nine Gait Variable Score (GVS), corresponding to major lower limb joints: the MAP (Movement Analysis Profile). Many studies have reported the interest of the GPS to analysis gait of subjects with CP: good inter-session reliability, predictor of postoperative kinematic improvement, minimal clinical threshold calculated at 1.6°, significant relationship with clinical data (joint contractures), and sensibility to change after a single-event multilevel surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL GROUP | – | Other: Gait Profile Score, Other: Gait Visual ScoreChildren and teenagers with CP with an instrumented gait analysis performed since 2019. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents with cerebral palsy treated at the Saint-Etienne University Hospital will be included.
Key inclusion criteria (6 listed)
- Etiology of cerebral palsy
- Unilateral, bilateral, triplegic or quadriplegic forms of cerebral palsy.
- 6 to 18 years old
- GMFCS (Gross Motor Function Classification System) I to III
- Instrumented gait analysis of the laboratory of St-Etienne
Key exclusion criteria (2 listed)
- Etiology others than cerebral palsy as defined classically (ex: ischemic infarcts in a child older than two years).
- Previous surgery in lower-limb.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait Profile ScoreGait Profile Score in degrees, calculated from kinematic raw data with the Gdi_GPS_calculator spreadsheet developed by Baker (2009). | Other | EXPERIMENTAL GROUP |
| Gait Visual ScoreGait Visual Score in degrees, calculated from kinematic raw data with the Gdi_GPS_calculator spreadsheet developed by Baker (2009) | Other | EXPERIMENTAL GROUP |
Primary outcome
Degrees of Gait Profile Score overall
Time frame: Day 1
Analyze Degrees of Gait Profile Score overall
2 secondary outcomes
Gait Profile Score right
Time frame: Month 2
Gait Profile Score left
Time frame: Year 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- 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. This study is not recruiting at the moment.
Clément BOULARD, physiotherapist principal investigator
CHU de Saint-Etienne
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 and Gait Disorders in Children, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 10 Jan 2025. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Degrees of Gait Profile Score overall (time frame: Day 1). 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 10 Jan 2025.