Cerebral PalsyNCT04129749
Influence of Fatigue on the Walking Pattern in Cerebral Palsy Patients.
An observational study of Cerebral Palsy, run by Fondation Lenval at 1 site in France.
Trial summary
To date, studies do not study the influence of external disturbing factors on the market. The main hypothesis is that the stopping of walking in paralyzed cerebral patients is mainly due to an increase in the energy cost of walking. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Real-Time Analysis Interactive Lab
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 17 Nov 2019to Dec 2021
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: cerebral palsy patients
Who may be able to join
- children aged 7 to 18 years (diplegic, hemiparetic or tetraparetic) requiring treatment with botulinum toxin
- followed at the Lenval Foundation
- walking alone more than 6 minutes
- parental information and no disagreement
Who cannot join
- Modification of spasticity treatments within 6 months of evaluation: baclofen pump, oral baclofen, retraction surgery (tenotomy, tendon lengthening, arthrodesis ...)
- dyskinesia
- Cognitive disorders in children that do not allow the use of GRAIL
- Contraindication to Botulinum Toxin (myasthenia, hypersensitivity and infections)
- Contraindication to physical activity (intercurrent pathology)
Trial locations and contacts
1 site in 1 country.
About this study
To date, studies do not study the influence of external disturbing factors on the market.
The main hypothesis is that the stopping of walking in paralyzed cerebral patients is mainly due to an increase in the energy cost of walking.
The secondary objectives are to study the causes of the increase in the energy cost of walking (modification of muscle coordination / increase of co-activations, loss of strength, etc.).
This study will use the GRAIL combining an instrumented treadmill, a motion capture system (Vicon System), an electromyographic system as well as a virtual environment projected on a 180 ° screen
Read the detailed description
In most studies, the study of the gait of cerebral palsy patients is done through quantified walking analysis tests, objectively evaluating the kinetic and kinematic parameters, associated with the measurement of respiratory exchanges and heart rate.
Nevertheless this very objective evaluation does not really reflect the child's ability to perform the acts of everyday life that he wishes, and in particular, his ability to walk a long time.
It therefore appears that patients do not only want to walk better on an objective and analytical level but also aim to walk longer and improve their walking efficiency.
To date, studies do not study the influence of external disturbing factors on the market.
The main hypothesis is that the stopping of walking in paralyzed cerebral patients is mainly due to an increase in the energy cost of walking.
The main objective is to confirm this hypothesis. The secondary objectives are to study the causes of the increase in the energy cost of walking (modification of muscle coordination / increase of co-activations, loss of strength, etc.).
For that, the investigators will use a tool that is perfectly adapted: the GRAIL (Real-Time Analysis Interactive Lab). The GRAIL uses an instrumented treadmill, a motion capture system (Vicon System), an electromyographic system as well as a virtual environment is projected on a 180 ° screen. This equipment allows patients to walk spontaneously or at prescribed speeds to a standstill in a virtual and secure virtual reality environment. Throughout the duration of the test, the investigators will quantify the evolution of biomechanical (kinematic, kinetic and EMG) and physiological (gas analysis system) factors during walking.
This is a study conducted in a usual evaluation framework: market analysis is commonly indicated for paralyzed children, in order to assess their disability and to propose the best therapy. There was no inherent risk in the proposed study protocol, but possible fatigue is inevitably analyzed, which is not related to inclusion in this study.
- Conditions
- Cerebral Palsy
- Being tested
- Real-Time Analysis Interactive Lab
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-Time Analysis Interactive LabProcedure or surgery
The Real-Time Analysis Interactive Lab uses an instrumented treadmill, a motion capture system (Vicon System), an electromyographic system as well as a virtual environment is projected on a 180 ° screen. This equipment allows patients to walk spontaneously or at prescribed speeds to a standstill in a virtual and secure virtual reality environment.
| Study group | Role | What they receive |
|---|---|---|
| Real-Time Analysis Interactive Lab | walk spontaneously or at prescribed speeds of cerebral palsy patient to a standstill in a virtual and secure virtual reality environment. Receives: Procedure: Real-Time Analysis Interactive Lab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of energy cost during walk in cerebral palsy patients, by evolution of inter-segmental angle
Measure of energy cost during walk in cerebral palsy patients by quantify modification of muscle coordination / increase of co-activations, loss of strength of muscle.
This will be evaluated by the evolution of inter-segmental angles (degrees) during a 6 minutes walking test.
Measured: at baseline Day 0
Measure of energy cost during walk in cerebral palsy patients, by evolution of articular force
Measure of energy cost during walk in cerebral palsy patients by quantify modification of muscle coordination / increase of co-activations, loss of strength of muscle.
Also evaluated by the evolution of articular force (N/kg) during a 6 minutes walking test.
Measured: at baseline Day 0
Measure of energy cost during walk in cerebral palsy patients by evolution of articular moment
Measure of energy cost during walk in cerebral palsy patients by quantify modification of muscle coordination / increase of co-activations, loss of strength of muscle.
Also evaluated by the evolution of articular moment (N.m/kg) during a 6 minutes walking test.
Measured: at baseline Day 0
Measure of energy cost during walk in cerebral palsy patients by evolution of articular power
Measure of energy cost during walk in cerebral palsy patients by quantify modification of muscle coordination / increase of co-activations, loss of strength of muscle.
Also evaluated by the evolution of articular power (W/kg) during a 6 minutes walking test
Measured: at baseline Day 0
Secondary outcomes (6)
quantification of biomechanical factors during walking by evolution of inter-segmental angles
Measure of kinematic and kinetic parameters during walk in cerebral palsy patients.
This will be evaluated by the evolution of inter-segmental angles (degrees) during a 6 minutes walking test.
Measured: at baseline Day 0
quantification of biomechanical factors during walking by evolution of articular force
Measure of kinematic and kinetic parameters during walk in cerebral palsy patients.
This will be evaluated by the evolution of articular force (N/kg) during a 6 minutes walking test.
Measured: at baseline Day 0
quantification of biomechanical factors during walking by evolution of articular moment
Measure of kinematic and kinetic parameters during walk in cerebral palsy patients.
This will be evaluated by the evolution of articular moment (N.m/kg) during a 6 minutes walking test.
Measured: at baseline Day 0
quantification of biomechanical factors during walking by evolution of of articular power
Measure of kinematic and kinetic parameters during walk in cerebral palsy patients.
This will be evaluated by the evolution of of articular power (W/kg) during a 6 minutes walking test.
Measured: at baseline Day 0
measure of physiological factors during walking by evolution of oxygen consummation
measure of O2 consummation during walk in cerebral palsy patients by a gas system analysis.
This will be evaluated by the evolution of O2 consummation during walk during a 6 minutes walking test.
Measured: at baseline Day 0
measure of physiological factors during walking by evolution of carbon dioxide consummation
measure of CO2 consummation during walk in cerebral palsy patients by a gas system analysis.
This will be evaluated by the evolution of CO2 consummation during walk during a 6 minutes walking test..
Measured: at baseline Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start17 Nov 2019
- Primary completionJun 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: cancelled study
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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RAMPAL Virginie, MD, Principal investigator, Fondation Lenval - Nice Children Hôpitaux Pédiatriques de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04129749
- Sponsor's protocol ID
- 19-HPNCL-01
- Status last verified
- Jul 2021
- First submitted
- 4 Apr 2019
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Fatigue on the Walking Pattern in Cerebral Palsy Patients.
- ClinicalTrials.gov ID
- NCT04129749
- Acronym / sponsor ID
- 19-HPNCL-01
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: cancelled study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- 17 Nov 2019 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 17 Oct 2019 (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.
To date, studies do not study the influence of external disturbing factors on the market.
The main hypothesis is that the stopping of walking in paralyzed cerebral patients is mainly due to an increase in the energy cost of walking.
The secondary objectives are to study the causes of the increase in the energy cost of walking (modification of muscle coordination / increase of co-activations, loss of strength, etc.).
This study will use the GRAIL combining an instrumented treadmill, a motion capture system (Vicon System), an electromyographic system as well as a virtual environment projected on a 180 ° screen
Detailed description
In most studies, the study of the gait of cerebral palsy patients is done through quantified walking analysis tests, objectively evaluating the kinetic and kinematic parameters, associated with the measurement of respiratory exchanges and heart rate.
Nevertheless this very objective evaluation does not really reflect the child's ability to perform the acts of everyday life that he wishes, and in particular, his ability to walk a long time.
It therefore appears that patients do not only want to walk better on an objective and analytical level but also aim to walk longer and improve their walking efficiency.
To date, studies do not study the influence of external disturbing factors on the market.
The main hypothesis is that the stopping of walking in paralyzed cerebral patients is mainly due to an increase in the energy cost of walking.
The main objective is to confirm this hypothesis. The secondary objectives are to study the causes of the increase in the energy cost of walking (modification of muscle coordination / increase of co-activations, loss of strength, etc.).
For that, the investigators will use a tool that is perfectly adapted: the GRAIL (Real-Time Analysis Interactive Lab). The GRAIL uses an instrumented treadmill, a motion capture system (Vicon System), an electromyographic system as well as a virtual environment is projected on a 180 ° screen. This equipment allows patients to walk spontaneously or at prescribed speeds to a standstill in a virtual and secure virtual reality environment. Throughout the duration of the test, the investigators will quantify the evolution of biomechanical (kinematic, kinetic and EMG) and physiological (gas analysis system) factors during walking.
This is a study conducted in a usual evaluation framework: market analysis is commonly indicated for paralyzed children, in order to assess their disability and to propose the best therapy. There was no inherent risk in the proposed study protocol, but possible fatigue is inevitably analyzed, which is not related to inclusion in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Real-Time Analysis Interactive Lab | – | Procedure: Real-Time Analysis Interactive Labwalk spontaneously or at prescribed speeds of cerebral palsy patient to a standstill in a virtual and secure virtual reality environment. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- cerebral palsy patients
Key inclusion criteria (4 listed)
- children aged 7 to 18 years (diplegic, hemiparetic or tetraparetic) requiring treatment with botulinum toxin
- followed at the Lenval Foundation
- walking alone more than 6 minutes
- parental information and no disagreement
Key exclusion criteria (5 listed)
- Modification of spasticity treatments within 6 months of evaluation: baclofen pump, oral baclofen, retraction surgery (tenotomy, tendon lengthening, arthrodesis ...)
- dyskinesia
- Cognitive disorders in children that do not allow the use of GRAIL
- Contraindication to Botulinum Toxin (myasthenia, hypersensitivity and infections)
- Contraindication to physical activity (intercurrent pathology)
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 |
|---|---|---|
| Real-Time Analysis Interactive LabThe Real-Time Analysis Interactive Lab uses an instrumented treadmill, a motion capture system (Vicon System), an electromyographic system as well as a virtual environment is projected on a 180 ° screen. This equipment allows patients to walk spontaneously or at prescribed speeds to a standstill in a virtual and secure virtual reality environment. | Procedure or surgery | Real-Time Analysis Interactive Lab |
Primary outcome
Measure of energy cost during walk in cerebral palsy patients, by evolution of inter-segmental angle
Time frame: at baseline Day 0
Measure of energy cost during walk in cerebral palsy patients by quantify modification of muscle coordination / increase of co-activations, loss of strength of muscle. This will be evaluated by the evolution of inter-segmental angles (degrees) during a 6 minutes walking test.
Measure of energy cost during walk in cerebral palsy patients, by evolution of articular force
Time frame: at baseline Day 0
Measure of energy cost during walk in cerebral palsy patients by quantify modification of muscle coordination / increase of co-activations, loss of strength of muscle. Also evaluated by the evolution of articular force (N/kg) during a 6 minutes walking test.
Measure of energy cost during walk in cerebral palsy patients by evolution of articular moment
Time frame: at baseline Day 0
Measure of energy cost during walk in cerebral palsy patients by quantify modification of muscle coordination / increase of co-activations, loss of strength of muscle. Also evaluated by the evolution of articular moment (N.m/kg) during a 6 minutes walking test.
Measure of energy cost during walk in cerebral palsy patients by evolution of articular power
Time frame: at baseline Day 0
Measure of energy cost during walk in cerebral palsy patients by quantify modification of muscle coordination / increase of co-activations, loss of strength of muscle. Also evaluated by the evolution of articular power (W/kg) during a 6 minutes walking test
6 secondary outcomes
quantification of biomechanical factors during walking by evolution of inter-segmental angles
Time frame: at baseline Day 0
quantification of biomechanical factors during walking by evolution of articular force
Time frame: at baseline Day 0
quantification of biomechanical factors during walking by evolution of articular moment
Time frame: at baseline Day 0
quantification of biomechanical factors during walking by evolution of of articular power
Time frame: at baseline Day 0
measure of physiological factors during walking by evolution of oxygen consummation
Time frame: at baseline Day 0
measure of physiological factors during walking by evolution of carbon dioxide consummation
Time frame: at baseline Day 0
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
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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.
RAMPAL Virginie, MD principal investigator
Fondation Lenval - Nice Children Hôpitaux Pédiatriques de Nice
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 Fondation Lenval 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 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: withdrawn, as of the sponsor's last update on 21 Jul 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
Measure of energy cost during walk in cerebral palsy patients, by evolution of inter-segmental angle (time frame: at baseline Day 0). The study lists 4 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 21 Jul 2021.