Cerebral PalsyNCT05551364
Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy
A study testing ATLAS 2030 exoskeleton in people with Cerebral Palsy, run by MarsiBionics at 6 sites in Spain.
Trial summary
The main objective of this study is to assess the usability and efficacy of receiving therapy with the peaditric exoskeleton ATLAS 2030in children with gait impairment due to a cerebral palsy condition. 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 exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesSpain
- Study dates
- 5 Sep 2022to 30 Aug 2023
- 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 3 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Medical authorization to for standing, gait training and weight bearing.
- Maximum user weight of 35 kg.
- 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.
- Hip width (between greater trochanteres) less than or equal to 35 cm.
- Do not have an allergy to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
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- Ability to achieve the neutral position of the ankle, during the use of the device with or without technical aids.
- Informed consent signed by legal guardians.
- Confirmed diagnosis of cerebral palsy affecting the ability to walk.
- Stable medical condition without modifications of the specific medication for the disease in the last 6 months, and other additional medication in the last month.
- Patient in follow-up according to the normal standards recommended for his illness.
Who cannot join
- More than 20º of hip flessum at the time of using the exoskeleton.
- More than 20º of knee flessum at the time of using the exoskeleton.
- 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.
- Refusal of the patient or legal guardian to include the child in the study.
- Skin problems (diseases, allergies, sensitivity ...) that prevent the use of exoskeleton accessories on the patient's skin.
- Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
ATENPACE
Madrid
Centre for Automation and Robotics, Marsi Care
Madrid
Fundación Bobath
Madrid
Colegio de Educación Especial San Martín de Porres (ATADES)
Zaragoza, Aragon, 35012
Hospital Universitario Miguel Servet
Zaragoza
Universidad de Zaragoza
Zaragoza
About this study
Official title: Usabilidad y Efectividad Del Exoesqueleto ATLAS2030 en Variables físicas, Emocionales y Funcionales en niños Con parálisis Cerebral
The main objective of this study is to assess the usability and efficacy of receiving therapy with the peaditric exoskeleton ATLAS 2030in children with gait impairment due to a cerebral palsy condition. It will be valued the impact of rehabilitation with the exoskeleton at the physical level on parameters such as joint range, spasticity, as well as the impact in quality of life. It is also assessed the impact at the level of functionality of the participants, through the administration of different functional assessment scales.
- Conditions
- Cerebral Palsy
- Being tested
- ATLAS 2030 exoskeleton
- Keywords
- exoskeleton, paediatric, gait, robotic gait assited training
- 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 2030 exoskeletonDevice
Individualized Rehabilitation Treatment with the ATLAS 2030 Exoskeleton consists of the following phases:
- Telephone contact phase (1 session)
- Inclusion Phase (1 session)
- Signing of informed consent (1 session)
- Initial Evaluation Phase (1 session)
- Treatment Phase (1st part) (7 sessions)
- Monthly Evaluation Phase (1 session)
- Treatment Phase (2nd part) (7 sessions)
- Monthly Evaluation Phase (1 session)
- Treatment Phase (3rd part) (7 sessions)
- Final Evaluation Phase and results (2 sessions)
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment | No intervention | The children will continue with their current rehabilitation program |
| Treatment with the ATLAS 2030 Exoskeleton | Experimental | The children will receive 2 hours of exoskeleton ATLAS 2030 gait training a week for 3 months Receives: Device: ATLAS 2030 exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Classification System
To indentify the diffrent levels of the Gross Motor Function Classification System who can use the ATLAS 2030 exoskeleton. The Gross Motor Function Classification System goes from Level 1 (can walk indoors and outdoors and climb stairs without using hands for support; can perform usual activities such as running and jumping; has decreased speed, balance and coordination) to Level 5 (has physical impairments that restrict voluntary control of movement and the ability to maintain head and neck position against gravity; is impaired in all areas of motor function; cannot sit or stand independently, even with adaptive equipment; cannot independently walk, though may be able to use powered mobility)
Measured: Every month up to 3 months
To quantify number of steps taken within the device
Quantity of steps taken within the exoskeleton
Measured: Every session up to 28 sessions
Changes in joint range of motion
To evaluate the joint range of motion changes at the hip, knee and ankle after the ATLAS 2030 use measured by goniometer
Measured: Every session up to 28 sessions
Changes in spasticity
To evaluate spasticity changes at the lower limb muscle groups after ATLAS 2030 use by Modified Asworth Scale
Measured: Every session up to 28 sessions
Changes in the Six-Minute Walking Test performance
To assess changes in the distance the child can walk in six minutes by using the Six-Minute Walking Test
Measured: Every month up to three months
Changes in the 10 Meters Walking Test performance
To assess changes in the time needed to walk 10 meters by using the 10 Meters Walking Test
Measured: Every month up to three months
Changes in the time walked within the device
To assess possible changes in the time walked within the device
Measured: Three months
Changes in the Gross Motor Function Measure 88 for children with cerebral palsy (GMFM-88)
To evaluate possible changes in the gross motor function after 3 months of ATLAS 2030 use twice a week where a higher score means child´s gross motor function is better
Measured: Every month up to three months
Changes in the Functional Independence Measure for Children (WeeFim)
To evaluate possible changes in the overall functionality after 3 months of ATLAS 2030 use twice a week by using the Functional Independence Measure for Children where a higher score means the child is more functional, more independant
Measured: Every month up to three months
Cerebral Palsy Quality of Life
To assess possible changes in the quality of life of the children after using the ATLAS 2030 for 3 months twice a week by using the Cerebral Palsy Quallity of Life scale where a higher percentage means a better quality of life
Measured: Three months
Secondary outcomes (4)
Safety of the ATLAS 2030
Measured as the occurrence of adverse events such as onset of pain, fatigue, presence of falls or alteration of the integrity of the user's skin, by the use of the device.
Measured: at study completion
The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
To assess both professionals and patients´satisfaction when using the ATLAS 2030
Measured: at study completion
Acceptability
Measured through the dropout rate of the participants.
Measured: at study completion
Accessibility
Measure such as the relationship between the number of patients recruited and potential patients who were not recruited
Measured: at study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start5 Sep 2022
- Primary completion2 Jun 2023
- Study completion30 Aug 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- MarsiBionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Miguel Servet, ATADES, Universidad de Zaragoza, Spanish National Research Council, Fundación Bobath Madrid, ATENPACE Madrid
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551364
- Sponsor's protocol ID
- A30-ATADES-CP
- Status last verified
- Dec 2023
- First submitted
- 2 Sep 2022
- 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
- Usabilidad y Efectividad Del Exoesqueleto ATLAS2030 en Variables físicas, Emocionales y Funcionales en niños Con parálisis Cerebral
- ClinicalTrials.gov ID
- NCT05551364
- Acronym / sponsor ID
- A30-ATADES-CP
- Conditions
- Cerebral Palsy
- Keywords
- exoskeleton, paediatric, gait, robotic gait assited training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- MarsiBionicsIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Miguel Servet, ATADES, Universidad de Zaragoza, Spanish National Research Council, Fundación Bobath Madrid, ATENPACE Madrid
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 2 Jun 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 22 Sep 2022 (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 main objective of this study is to assess the usability and efficacy of receiving therapy with the peaditric exoskeleton ATLAS 2030in children with gait impairment due to a cerebral palsy condition. It will be valued the impact of rehabilitation with the exoskeleton at the physical level on parameters such as joint range, spasticity, as well as the impact in quality of life. It is also assessed the impact at the level of functionality of the participants, through the administration of different functional assessment scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment | No intervention | –The children will continue with their current rehabilitation program |
| Treatment with the ATLAS 2030 Exoskeleton | Experimental | Device: ATLAS 2030 exoskeletonThe children will receive 2 hours of exoskeleton ATLAS 2030 gait training a week for 3 months |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Medical authorization to for standing, gait training and weight bearing.
- Maximum user weight of 35 kg.
- 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.
- Hip width (between greater trochanteres) less than or equal to 35 cm.
Key exclusion criteria (8 listed)
- More than 20º of hip flessum at the time of using the exoskeleton.
- More than 20º of knee flessum at the time of using the exoskeleton.
- 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.
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 2030 exoskeletonIndividualized Rehabilitation Treatment with the ATLAS 2030 Exoskeleton consists of the following phases: 1. Telephone contact phase (1 session) 2. Inclusion Phase (1 session) 3. Signing of informed consent (1 session) 4. Initial Evaluation Phase (1 session) 5. Treatment Phase (1st part) (7 sessions) 6. Monthly Evaluation Phase (1 session) 7. Treatment Phase (2nd part) (7 sessions) 8. Monthly Evaluation Phase (1 session) 9. Treatment Phase (3rd part) (7 sessions) 10. Final Evaluation Phase and results (2 sessions) | Device | Treatment with the ATLAS 2030 Exoskeleton |
Primary outcome
Gross Motor Function Classification System
Time frame: Every month up to 3 months
To indentify the diffrent levels of the Gross Motor Function Classification System who can use the ATLAS 2030 exoskeleton. The Gross Motor Function Classification System goes from Level 1 (can walk indoors and outdoors and climb stairs without using hands for support; can perform usual activities such as running and jumping; has decreased speed, balance and coordination) to Level 5 (has physical impairments that restrict voluntary control of movement and the ability to maintain head and neck position against gravity; is impaired in all areas of motor function; cannot sit or stand independently, even with adaptive equipment; cannot independently walk, though may be able to use powered mobility)
To quantify number of steps taken within the device
Time frame: Every session up to 28 sessions
Quantity of steps taken within the exoskeleton
Changes in joint range of motion
Time frame: Every session up to 28 sessions
To evaluate the joint range of motion changes at the hip, knee and ankle after the ATLAS 2030 use measured by goniometer
Changes in spasticity
Time frame: Every session up to 28 sessions
To evaluate spasticity changes at the lower limb muscle groups after ATLAS 2030 use by Modified Asworth Scale
Changes in the Six-Minute Walking Test performance
Time frame: Every month up to three months
To assess changes in the distance the child can walk in six minutes by using the Six-Minute Walking Test
Changes in the 10 Meters Walking Test performance
Time frame: Every month up to three months
To assess changes in the time needed to walk 10 meters by using the 10 Meters Walking Test
Changes in the time walked within the device
Time frame: Three months
To assess possible changes in the time walked within the device
Changes in the Gross Motor Function Measure 88 for children with cerebral palsy (GMFM-88)
Time frame: Every month up to three months
To evaluate possible changes in the gross motor function after 3 months of ATLAS 2030 use twice a week where a higher score means child´s gross motor function is better
Changes in the Functional Independence Measure for Children (WeeFim)
Time frame: Every month up to three months
To evaluate possible changes in the overall functionality after 3 months of ATLAS 2030 use twice a week by using the Functional Independence Measure for Children where a higher score means the child is more functional, more independant
Cerebral Palsy Quality of Life
Time frame: Three months
To assess possible changes in the quality of life of the children after using the ATLAS 2030 for 3 months twice a week by using the Cerebral Palsy Quallity of Life scale where a higher percentage means a better quality of life
4 secondary outcomes
Safety of the ATLAS 2030
Time frame: at study completion
The Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
Time frame: at study completion
Acceptability
Time frame: at study completion
Accessibility
Time frame: at study completion
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 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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATLAS 2030 exoskeleton in people with Cerebral Palsy, run by MarsiBionics at 6 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 11 inclusion and 8 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 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 6 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?
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?
Gross Motor Function Classification System (time frame: Every month up to 3 months). The study lists 10 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 27 Sep 2024.