Cerebral Palsy (CP)NCT06740006
Retrospective Study on the WalkOn AFO in Children or Teenagers With Neurological Pathologies
An observational study of Cerebral Palsy (CP) and Spastic Paraplegia, run by Otto Bock France SNC at 1 site in France.
Trial summary
The goal of this observational study is to assess the interest of prefabricated carbon fiber ankle foot orthoses (AFO) in children and teenagers with central or peripheral neurological pathologies. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Cerebral Palsy (CP), Spastic Paraplegia, Spinal Cord Injuries (SCI)
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2024to 28 Feb 2025
- 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 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children or tennagers whose gait is affected by central or peripheral motor impairments and who are followed in the rehabilitation center
Who may be able to join
- Patient, child or adolescent, whose gait is affected by central or peripheral motor impairments
- Patient who has carried out a one-off trial of a WalkOn AFO (Ankle-Foot Orthosis) within the last 3 years prior to the beginning of the study (inclusion period)
- Patient whose quantified gait analysis with the WalkOn AFO and without orthosis is available in the medical file and whose date is within the inclusion period
- The investigator has verified that the patient and the parental authorities have received the information note concerning the study
- The investigator has verified that the person and the parental authorities do not object to the processing of data necessary for the study
Who cannot join
- Patients or holders of parental authority objecting to the processing of data within the framework of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Prefabricated Carbon Orthoses in the Therapeutic Arsenal of Children and Adolescents Affected by Central or Peripheral Neurological Pathologies: Retrospective Study on Gait Parameters and Prescription Criteria
The goal of this observational study is to assess the interest of prefabricated carbon fiber ankle foot orthoses (AFO) in children and teenagers with central or peripheral neurological pathologies. The main question it aims to answer is:
Does prefabricated carbon AFO improve gait and provide user satisfaction? In current practice, all patients with gait impairments were fitted with this orthosis and had a 3D gait analysis with and without AFO. Biomecanical and follow-up data collected in current practice are analysed in this study in order to answer the question.
- Conditions
- Cerebral Palsy (CP), Spastic Paraplegia, Spinal Cord Injuries (SCI), Spina Bifida, Neuropathy (Disorder)
- Medical subject headings
- Cerebral Palsy, Paraplegia, Spinal Cord Injuries, Spinal Dysraphism
What is being measured
The primary outcome is the main question the study is designed to answer.
Stride length
Biomechanical parameter: the distance between successive points of initial contact of the same foot (m)
Measured: After 1 hour with the device
Secondary outcomes (11)
Walking speed
Biomechanical parameter: the walking speed is the time one takes to walk a specified distance on level surfaces over a short distance (m/s).
Measured: After 1 hour with the device
Walking cadence
Biomechanical parameter: the walking rate is equal to the walking speed divided by the stride lenth (steps/min).
Measured: After 1 hour with the device
Gait Profile Score
Biomechanical parameter: the Gait Profile Score (GPS) is a clinical index that can be used to measure the overall deviation of gait data relative to normative data (°).
Measured: After 1 hour with the device
Gait Variable Score for the Hip
Biomechanical parameter: the Gait Variable Score describes the joint specific measures of gait variability for the Hip (°).
Measured: After 1 hour with the device
Gait Variable Score for the Knee
Biomechanicl parameter: the Gait Variable Score describes the joint specific measures of gait variability for the Knee (°).
Measured: After 1 hour with the device
Gait Variable Score for the Ankle
Biomechanical parameter: the Gait Variable Score describes the joint specific measures of gait variability for the Ankle (°).
Measured: After 1 hour with the device
Walk ratio
Biomechanical parameter: the walk ration represents the relationship between the amplitude and frequency of rhythmic leg movement during walking (m/step/min).
Measured: After 1 hour with the device
Antero-posterior Ground Force Reaction
Biomechanical parameter: the antero-posterior Ground Force Reaction is the antero-posterior force exerted by the ground on a body in contact with it (N).
Measured: Afer 1 hour with the device
Time of Stance
Biomechanical parameter: the time of stance is the time one spend with the foot on the floor (s)
Measured: After 1 hour with the device
Stance percentage
Biomechanical parameter: the stance percentage is the percentage of time one spend with the foot on the floor during the gait cycle (%)
Measured: After 1 hour with the device
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
Questionnaire: the QUEST measures the user satisfaction. It contains an evaluation part regarding the technology of the device on 8 items and one regarding services around the device on 4 items. It allows the patient to express himself on the criteria that are most important to him. An average satisfaction value can be calculated on a scale going from 1 to 5, with 1= "Not at all satisfied", 2="Not very satisfied", 3="more or less satisfied", 4="Quite satisfied" or 5="Very satisfied". The final QUEST score is the average obtained over all 12 items. Technology and services sub-scores can also be calculated.
In this study, the french version ESAT (Evaluation des la Satisfaction envers une Aide Technique) is used.
This questionnaire only concerns patients who purchase the orthosis, and was administered during a follow-up visit of the patient in the rehabilitation center.
Measured: Between 3 to 18 months after the fitting with the device / Long-term follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start3 Sep 2024
- Primary completion6 Dec 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otto Bock France SNC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740006
- Sponsor's protocol ID
- BP-11-PT008
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2024
- Last updated
- 24 Sep 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 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Prefabricated Carbon Orthoses in the Therapeutic Arsenal of Children and Adolescents Affected by Central or Peripheral Neurological Pathologies: Retrospective Study on Gait Parameters and Prescription Criteria
- ClinicalTrials.gov ID
- NCT06740006
- Acronym / sponsor ID
- BP-11-PT008
- Conditions
- Cerebral Palsy (CP), Spastic Paraplegia, Spinal Cord Injuries (SCI), Spina Bifida, Neuropathy (Disorder)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Otto Bock France SNCIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 18 Dec 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 the interest of prefabricated carbon fiber ankle foot orthoses (AFO) in children and teenagers with central or peripheral neurological pathologies. The main question it aims to answer is:
Does prefabricated carbon AFO improve gait and provide user satisfaction? In current practice, all patients with gait impairments were fitted with this orthosis and had a 3D gait analysis with and without AFO. Biomecanical and follow-up data collected in current practice are analysed in this study in order to answer the question.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children or tennagers whose gait is affected by central or peripheral motor impairments and who are followed in the rehabilitation center
Key inclusion criteria (5 listed)
- Patient, child or adolescent, whose gait is affected by central or peripheral motor impairments
- Patient who has carried out a one-off trial of a WalkOn AFO (Ankle-Foot Orthosis) within the last 3 years prior to the beginning of the study (inclusion period)
- Patient whose quantified gait analysis with the WalkOn AFO and without orthosis is available in the medical file and whose date is within the inclusion period
- The investigator has verified that the patient and the parental authorities have received the information note concerning the study
- The investigator has verified that the person and the parental authorities do not object to the processing of data necessary for the study
Key exclusion criteria (1 listed)
- Patients or holders of parental authority objecting to the processing of data within the framework of the study
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
Stride length
Time frame: After 1 hour with the device
Biomechanical parameter: the distance between successive points of initial contact of the same foot (m)
11 secondary outcomes
Walking speed
Time frame: After 1 hour with the device
Walking cadence
Time frame: After 1 hour with the device
Gait Profile Score
Time frame: After 1 hour with the device
Gait Variable Score for the Hip
Time frame: After 1 hour with the device
Gait Variable Score for the Knee
Time frame: After 1 hour with the device
Gait Variable Score for the Ankle
Time frame: After 1 hour with the device
Walk ratio
Time frame: After 1 hour with the device
Antero-posterior Ground Force Reaction
Time frame: Afer 1 hour with the device
Time of Stance
Time frame: After 1 hour with the device
Stance percentage
Time frame: After 1 hour with the device
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
Time frame: Between 3 to 18 months after the fitting with the device / Long-term follow-up visit
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 24 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
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 (CP) and Spastic Paraplegia, run by Otto Bock France SNC 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 5 inclusion and 1 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 24 Sep 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?
Stride length (time frame: After 1 hour with the device). 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 24 Sep 2025.