Cerebral PalsyNCT05926635
Efficacy of a Rehabilitation Program With the Pediatric Exoskeleton ATLAS 2030 in Pediatric Patients With Cerebral Palsy
An observational study of Cerebral Palsy, run by MarsiBionics at 5 sites in Spain.
Trial summary
Cerebral Palsy (CP) is the first cause of motor disability in children worldwide. ATLAS 2030 is a robotic gait exoskeleton designed to rehabilitate children with motor disability. The objective of this study is to analyse the efficacy of a training program with ATLAS 2023 in chilren with CP. Read more about this study
- Who is it for?
- Ages 3 to 14 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- ATLAS 2030
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 5 sitesSpain
- Study dates
- 3 Aug 2023to 11 May 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 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children diagnosed with cerebral palsy with Gross Motor Function Classification level III (children walk using a hand-held mobility device in most indoor settings) or IV (children use methods of mobility that require physical assistance or powered mobility in most settings).
Who may be able to join
- Medical authorization for standing, gait training and weight bearing.
- Informed consent signed by legal guardians.
- Confirmed diagnosis of cerebral palsy GMFCS levels III or IV.
- Proper family acceptance and commitment level.
- Receiving a minimum of 2 hours of therapy/activities promoting physical activity.
- Maximum user weight of 35 kg.
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- Hip width (between greater trochanteres) less than or equal to 35 cm.
- Length of the thigh (distance from the greater trochanter to the lateral condyle of the tibia) from 24cm to 33cm.
- Tibia leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 23cm to 32cm.
- Shoe size 27-33 (EU)
Who cannot join
- More than 8 sessions of robotic therapy during a month in the previous year to the beginning of the study.
- Intensive rehabilitation during the study.
- Imposibility of the family to fulfill treatment calendar.
- Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device.
- More than 20º of hip and/or knee flessum at the time of using the exoskeleton.
- Necessity to walk with 10º of hip abduction.
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- Necessity to walk with more than 9º of ankle dorsiflexion or plantar flexion or impossibility to use an orthosis to reach 90º in the ankle joint.
- Severe skin lesion on parts of the lower extremities that are in contact with the device.
- Scheduled surgery (rachis, limbs) for the duration of the study or surgery performed (rachis, extremities) in the last 6 months.
- History of fracture without trauma. History of bone fracture traumatic in lower extremities or pelvic girdle in the last 3 months.
- Severe rigid orthopedic deformities of the spine and/or lower limbs.
- Cognitive or conductual disorders that may lead to a lack of adherence to the attachment to the device.
- Conditions that provoke exercise intolerance.
- Conductual disorders that may interfere with the use of the device or their participation in the study, like impulsiveness or the inability to understand simple comands.
- Allergy to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Universitario Gregorio Marañón
Madrid, 28007
Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación
Madrid, 28009
Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia
Madrid, 28009
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
About this study
Cerebral Palsy (CP) is the first cause of motor disability in children worldwide. ATLAS 2030 is a robotic gait exoskeleton designed to rehabilitate children with motor disability. The objective of this study is to analyse the efficacy of a training program with ATLAS 2023 in chilren with CP.
Read the detailed description
A sample of children with CP will be divided into 2 groups, the experimental group will receive 32 sesions withe the ATLAS 2030 exoskeleton, whereas the control group will continue to receive their regular conventional therapy. Assessments will be performed at the beginning and the end of the intervention, as well as after 6, 9 and 12 months of the end of the intervention for follow-up.
- Conditions
- Cerebral Palsy
- Being tested
- ATLAS 2030
- Keywords
- exoskeleton, cerebral palsy, gait, rehabilitation
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATLAS 2030Device
sessions of rehabilitation with the ATLAS 2030 exoskeleton twice per week as part of their routine rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Exoskeleton group | sessions of rehabilitation with the ATLAS 2030 exoskeleton twice per week as part of their of their routine rehabilitation Receives: Device: ATLAS 2030 | |
| Control group | The children included in the control group will continue receiving their usual conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure-88 (GMFM-88)
To measure changes in gross motor function in children with cerebral palsy using the Gross Motor Functional Measure-88.
The minimum value is 0 and the maximum value is 100 .When the GMFM score is lower, the skill level is lower.
Measured: At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)
Secondary outcomes (3)
Modified Ashworth Scale (MAS)
changes in spasticity measured by the Modified Ashworth Scale (MAS). The spasticity of each muscle group is measured with a scale scored from 0 to 4, where 0 means no spasticity and 4 means the joint is fixed and therefore, the highest level of spasticity
Measured: Through study completion, along 1 year
Pediatric Quality of Life Inventory (PedsQLTM)
Changes in self perceived quality of life measured by the Pediatric Quality of Life Inventory (PedsQLTM). Every item is measured on a scale from 0 (higher quality of life) to 4 (lower quality of life)
Measured: At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)
Changes in Gait Deviation Index (GDI)
Changes in Gait Deviation Index (GDI) measured with a tridimensional motion analysis system
Measured: At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start3 Aug 2023
- Primary completion11 May 2025 (estimated)
- Study completion11 May 2025 (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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MarsiBionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Research Council, Spain, Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Hospital Universitario La Paz, Hospital Universitario 12 de Octubre, Hospital General Universitario Gregorio Marañon
- Responsible party
- Sponsor
- Investigators
- Olga Arroyo Riaño, Principal investigator, Hospital Universitario Gregorio MarañónMaría Teresa Vara Arias, Principal investigator, Hospital Infantil Universitario Niño JesúsIgnacio Martínez Caballero, Principal investigator, Hospital Infantil Universitario Niño JesúsSandra Espinosa García, Principal investigator, Hospital Univsersitario La PazSofía García de las Peñas, Principal investigator, Hospital 12 de OctubreElena García Armada, Principal investigator, National Research Council, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926635
- Sponsor's protocol ID
- SERMAS
- Status last verified
- Sep 2024
- First submitted
- 23 May 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Rehabilitation Program With the Pediatric Exoskeleton ATLAS 2030 in Pediatric Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05926635
- Acronym / sponsor ID
- SERMAS
- Conditions
- Cerebral Palsy
- Keywords
- exoskeleton, cerebral palsy, gait, rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- MarsiBionicsIndustry (pharma, biotech, devices)
- Collaborators
- National Research Council, Spain, Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Hospital Universitario La Paz, Hospital Universitario 12 de Octubre, Hospital General Universitario Gregorio Marañon
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 11 May 2025 (estimated)
- Study completion
- 11 May 2025 (estimated)
- First posted
- 3 Jul 2023 (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.
Cerebral Palsy (CP) is the first cause of motor disability in children worldwide. ATLAS 2030 is a robotic gait exoskeleton designed to rehabilitate children with motor disability. The objective of this study is to analyse the efficacy of a training program with ATLAS 2023 in chilren with CP.
Detailed description
A sample of children with CP will be divided into 2 groups, the experimental group will receive 32 sesions withe the ATLAS 2030 exoskeleton, whereas the control group will continue to receive their regular conventional therapy. Assessments will be performed at the beginning and the end of the intervention, as well as after 6, 9 and 12 months of the end of the intervention for follow-up.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exoskeleton group | – | Device: ATLAS 2030sessions of rehabilitation with the ATLAS 2030 exoskeleton twice per week as part of their of their routine rehabilitation |
| Control group | – | –The children included in the control group will continue receiving their usual conventional therapy |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children diagnosed with cerebral palsy with Gross Motor Function Classification level III (children walk using a hand-held mobility device in most indoor settings) or IV (children use methods of mobility that require physical assistance or powered mobility in most settings).
Key inclusion criteria (10 listed)
- Medical authorization for standing, gait training and weight bearing.
- Informed consent signed by legal guardians.
- Confirmed diagnosis of cerebral palsy GMFCS levels III or IV.
- Proper family acceptance and commitment level.
- Receiving a minimum of 2 hours of therapy/activities promoting physical activity.
Key exclusion criteria (15 listed)
- More than 8 sessions of robotic therapy during a month in the previous year to the beginning of the study.
- Intensive rehabilitation during the study.
- Imposibility of the family to fulfill treatment calendar.
- Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device.
- More than 20º of hip and/or knee flessum at the time of using the exoskeleton.
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 |
|---|---|---|
| ATLAS 2030sessions of rehabilitation with the ATLAS 2030 exoskeleton twice per week as part of their routine rehabilitation | Device | Exoskeleton group |
Primary outcome
Gross Motor Function Measure-88 (GMFM-88)
Time frame: At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)
To measure changes in gross motor function in children with cerebral palsy using the Gross Motor Functional Measure-88. The minimum value is 0 and the maximum value is 100 .When the GMFM score is lower, the skill level is lower.
3 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: Through study completion, along 1 year
Pediatric Quality of Life Inventory (PedsQLTM)
Time frame: At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)
Changes in Gait Deviation Index (GDI)
Time frame: At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 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. This study is not recruiting at the moment.
Olga Arroyo Riaño principal investigator
Hospital Universitario Gregorio Marañón
María Teresa Vara Arias principal investigator
Hospital Infantil Universitario Niño Jesús
Ignacio Martínez Caballero principal investigator
Hospital Infantil Universitario Niño Jesús
5 sites 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 MarsiBionics at 5 sites in Spain.
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 10 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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?
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?
Gross Motor Function Measure-88 (GMFM-88) (time frame: At the beginning and the end of the intervention (4 months), as well as after 6, 9 and 12 months (follow-up)). 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 27 Sep 2024.