CP (Cerebral Palsy)EOMEC/CPNCT02669160
Tolerance of a Motorized Orthosis Reproducing Walking Movement vs Conventional Standing-up Devices in Child With CP
A study testing PC Innowalk and Conventional passive stander in people with CP (Cerebral Palsy), run by Lille Catholic University at 4 sites in France.
Trial summary
Cerebral palsy (CP) includes all the sensorimotor development disorders leading to balance, gait and movement disruptions. These disorders are related to lesions of the central nervous system (CNS) that occurs at birth or during the early childhood. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- CP (Cerebral Palsy)
- What is being tested?
- PC Innowalk and Conventional passive stander
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesFrance
- Study dates
- Nov 2015to 18 Nov 2018
- Phase
- Interventional
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- CP children from 6 to 16 years old, and being less than 150 cms, able to receive a 30 minutes verticalization session (standard practice) without sign of discomfort or intolerance
- Communicating children
- Children who had never walked
Who cannot join
- Children presenting uncontrolled epileptic seizures
- No social insurance affiliation
- Refuse to participate in the study
- Orthopaedic surgery in 6 months which precede the inclusion.
- Injection of botulinum toxin in the 6 months which precede the inclusion.
- Previous neurotomy
Trial locations and contacts
4 sites in 1 country.
France4 sites
IEM Sévigné
Béthune, Hauts-de-France, 62400
IEM Vent de Bise
Liévin, Hauts-de-France, 62803
IEM Ellen Poidatz
Saint-Fargeau-Ponthierry, 77310
IEM Christian Dabbadie
Villeneuve-d'Ascq, Hauts-de-France, 59653
About this study
Official title: Tolerance of a Motorized Orthosis Reproducing Walking Movement Versus Conventional Passive Standing-up Devices in Children With Cerebral Palsy : A Non-inferiority, Randomised, Multicenter, Controlled Trial
Cerebral palsy (CP) includes all the sensorimotor development disorders leading to balance, gait and movement disruptions. These disorders are related to lesions of the central nervous system (CNS) that occurs at birth or during the early childhood. The therapeutic management of CP is essentially based on reeducation, but may also require specific medical treatments, orthopedic devices and sometimes bone surgery. Therefore, CP children are very often placed in specialized institutions with a significant socioeconomic impact. CP children suffer from various sensorimotor impairments, which may evolve into orthopedic deformations, justifying the implementation of restrictive devices. The French High Authority of Health (HAS) estimates that 50 % of CP children have pains when using contention or verticalization devices. These pains are mainly nociceptive and are caused by the passive constraint applied on contact points. Many clinical trials evaluating the physiotherapy benefits on CP patients have led to controversial results regarding the duration of the effect of this therapeutic approach. However, the improvement is more important when neuromuscular facilitation techniques are added to the reeducation program. Human neuronal adaptation and plasticity mechanisms are now understood, with the possibility of a potential partial recovery. Non-invasive stimulation methods and neurorehabilitation techniques could participate in the CNS re-calibration. Automated assisted movements have already been used and these processes showed an increase joint range of motion, bone density and decreased spasticity.
In recent years, "exoskeleton" devices have been used on subjects with spinal cord injuries allowing motor performances improvement.
This pilot study aims evaluating CP children's tolerance to motorized orthosis reproducing walking pattern compared with conventional passive standing-up devices. For this clinical trial, the investigators compare the behavior of CP children using a motorized orthosis reproducing walking pattern (Innowalk Pro Small) to the behavior of same children placed in their usual conventional passive device. The investigators hypothesis is that the Innowalk improves joints range of motion, enhances selective motor control, decreases the medium-term spasticity and offers at least the same tolerance as conventional passive devices.
- Conditions
- CP (Cerebral Palsy)
- Being tested
- PC Innowalk, Conventional passive stander
- Keywords
- Motorized Orthotic Devices, Minors, CP (Cerebral Palsy), Exoskeleton Device
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC InnowalkDevice
Conventional passive standerDevice
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Group of communicating CP children receiving a 30 minutes daily session of verticalization with a motorized orthosis reproducing walking movement (PS Innowalk) Receives: Device: PC Innowalk |
| Control | Other | Group of communicating CP children receiving a 30 minutes daily session of verticalization with their conventional passive stander. Receives: Device: Conventional passive stander |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance of pain according to the scale PPP (paediatric pain profile)
Paediatric Pain Profile (PPP) pain scale, validated for children with CP and completed by the carer (hetero questionnaire), assessed at D0, D1, W3 and W6.
Measured: 6 weeks
Secondary outcomes (6)
Lower limb muscular strength measured by the Ashworth scale
Ashworth muscle tone scale (assessment of spasticity). This validated scale is used to test the muscular reaction to stretching.
Measured: 6 weeks
Lower limb articular amplitudes measured by a goniometer
Assessment of joint amplitudes using goniometry. This passive assessment will be carried out for the ankle, knee and hip joints.
Measured: 6 weeks
Selective motor control measured by the CMS/Boyd scale
Evaluation of selective motor control using the CMS/Boyd scale.
Measured: 6 weeks
Stress evaluation measured by the change in heart rate from baseline linked to the verticalization system
Heart rate
Measured: 6 weeks
Identification and quantification (percentage) of adverse events and complications linked to the verticalization system
Number of complications (epileptic seizures, lesions, fractures, malaise, etc.) occurring during the study, description of these, severity grade, evolution, responsibility of the equipment, etc
Measured: 6 weeks
Number of days of utilization of the verticalization system until first complication or withdrawal of the study.
Time of use of device until first complication Time in use of device until discontinuation due to complication
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionNov 2018
- Study completion18 Nov 2018
Why it stopped: Difficulties encountered in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CP (Cerebral Palsy)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Région Nord-Pas de Calais, France, Initiatives de parents de Jeunes Epileptiques du Nord, Unité de Traitement des Signaux Biomédicaux - HEI, Made for Movement
- Responsible party
- Sponsor
- Investigators
- Jean-François Catanzariti, MD, Principal investigator, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669160
- Sponsor's protocol ID
- RC-P0032
- Acronym
- EOMEC/CP
- Status last verified
- Jun 2026
- First submitted
- 27 Jan 2016
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of a Motorized Orthosis Reproducing Walking Movement Versus Conventional Passive Standing-up Devices in Children With Cerebral Palsy : A Non-inferiority, Randomised, Multicenter, Controlled Trial
- ClinicalTrials.gov ID
- NCT02669160
- Acronym / sponsor ID
- EOMEC/CP / RC-P0032
- Conditions
- CP (Cerebral Palsy)
- Keywords
- Motorized Orthotic Devices, Minors, CP (Cerebral Palsy), Exoskeleton Device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties encountered in recruiting patients
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Région Nord-Pas de Calais, France, Initiatives de parents de Jeunes Epileptiques du Nord, Unité de Traitement des Signaux Biomédicaux - HEI, Made for Movement
- Study start
- Nov 2015
- Primary completion
- Nov 2018 (actual)
- Study completion
- 18 Nov 2018 (actual)
- First posted
- 29 Jan 2016 (estimated)
- 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.
Cerebral palsy (CP) includes all the sensorimotor development disorders leading to balance, gait and movement disruptions. These disorders are related to lesions of the central nervous system (CNS) that occurs at birth or during the early childhood. The therapeutic management of CP is essentially based on reeducation, but may also require specific medical treatments, orthopedic devices and sometimes bone surgery. Therefore, CP children are very often placed in specialized institutions with a significant socioeconomic impact. CP children suffer from various sensorimotor impairments, which may evolve into orthopedic deformations, justifying the implementation of restrictive devices. The French High Authority of Health (HAS) estimates that 50 % of CP children have pains when using contention or verticalization devices. These pains are mainly nociceptive and are caused by the passive constraint applied on contact points. Many clinical trials evaluating the physiotherapy benefits on CP patients have led to controversial results regarding the duration of the effect of this therapeutic approach. However, the improvement is more important when neuromuscular facilitation techniques are added to the reeducation program. Human neuronal adaptation and plasticity mechanisms are now understood, with the possibility of a potential partial recovery. Non-invasive stimulation methods and neurorehabilitation techniques could participate in the CNS re-calibration. Automated assisted movements have already been used and these processes showed an increase joint range of motion, bone density and decreased spasticity.
In recent years, "exoskeleton" devices have been used on subjects with spinal cord injuries allowing motor performances improvement.
This pilot study aims evaluating CP children's tolerance to motorized orthosis reproducing walking pattern compared with conventional passive standing-up devices. For this clinical trial, the investigators compare the behavior of CP children using a motorized orthosis reproducing walking pattern (Innowalk Pro Small) to the behavior of same children placed in their usual conventional passive device. The investigators hypothesis is that the Innowalk improves joints range of motion, enhances selective motor control, decreases the medium-term spasticity and offers at least the same tolerance as conventional passive devices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: PC InnowalkGroup of communicating CP children receiving a 30 minutes daily session of verticalization with a motorized orthosis reproducing walking movement (PS Innowalk) |
| Control | Other | Device: Conventional passive standerGroup of communicating CP children receiving a 30 minutes daily session of verticalization with their conventional passive stander. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- CP children from 6 to 16 years old, and being less than 150 cms, able to receive a 30 minutes verticalization session (standard practice) without sign of discomfort or intolerance
- Communicating children
- Children who had never walked
Key exclusion criteria (6 listed)
- Children presenting uncontrolled epileptic seizures
- No social insurance affiliation
- Refuse to participate in the study
- Orthopaedic surgery in 6 months which precede the inclusion.
- Injection of botulinum toxin in the 6 months which precede the inclusion.
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 |
|---|---|---|
| PC Innowalk | Device | Experimental |
| Conventional passive stander | Device | Control |
Primary outcome
Tolerance of pain according to the scale PPP (paediatric pain profile)
Time frame: 6 weeks
Paediatric Pain Profile (PPP) pain scale, validated for children with CP and completed by the carer (hetero questionnaire), assessed at D0, D1, W3 and W6.
6 secondary outcomes
Lower limb muscular strength measured by the Ashworth scale
Time frame: 6 weeks
Lower limb articular amplitudes measured by a goniometer
Time frame: 6 weeks
Selective motor control measured by the CMS/Boyd scale
Time frame: 6 weeks
Stress evaluation measured by the change in heart rate from baseline linked to the verticalization system
Time frame: 6 weeks
Identification and quantification (percentage) of adverse events and complications linked to the verticalization system
Time frame: 6 weeks
Number of days of utilization of the verticalization system until first complication or withdrawal of the study.
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Difficulties encountered in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- 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.
Jean-François Catanzariti, MD principal investigator
GHICL
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PC Innowalk and Conventional passive stander in people with CP (Cerebral Palsy), run by Lille Catholic University at 4 sites 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 stopped early (reason given: Difficulties encountered in recruiting patients). Results are not available in the source record.
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?
Tolerance of pain according to the scale PPP (paediatric pain profile) (time frame: 6 weeks). 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 11 Jun 2026.