Cerebral PalsyNCT06167954
Safety and Usability of a Robotic Gait Device for Children and Adolescents With Neurological or Neuromuscular Disease in Their Natural Environment
A study testing EXPLORER in people with Cerebral Palsy and Acquired Brain Injury, run by MarsiBionics at 5 sites in Spain.
Trial summary
The goal of this clinical trial is to analyze the usability and safety of the robotic gait device EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Cerebral Palsy, Acquired Brain Injury, Spinal Muscular Atrophy
- What is being tested?
- EXPLORER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesSpain
- Study dates
- 4 Dec 2023to 17 Aug 2024
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of cerebral palsy, acquired brain injury or spinal muscular atrophy
- Medical authorization for standing, gait training and weight bearing.
- Informed consent signed by legal guardians.
- Maximum user weight of 60 kg.
- Hip width (between greater trochanters) ≤40 cm.
- Length of the thigh (distance from the greater trochanter to the lateral condyle of the tibia) from 21cm to 36cm.
- Tibia leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 20cm to 35cm.
- Shoe size ≤40 (EU)
Who cannot join
- Medical contraindications for standing or walking.
- Non-reducible contractures or heterotropic ossifications above the degrees allowed by the device or out of the trajectory imposed by the device
- 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 non-reducible contractures at the time of using the exoskeleton.
- Necessity to walk with more than 5º of hip abduction.
- Impossibility to reach 5º of ankle dorsiflexion with ir without orthoses.
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- Lower length dysmetria that cannot be mitigated with a wedge under the foot.
- Skin lesion on parts of the lower extremities that are in contact with the device.
- History of fracture without trauma.
- Presence of other conditions causing exercise intolerance (such as uncontrolled hypertension, coronary artery disease, arrhythmia, congestive heart failure, severe pulmonary disease).
- Conductual disorders that may interfere with the use of the device or their participation in the study, like impulsiveness.
- Allergy to any of the EXPLORER materials: cotton, nylon, polyester, PPS, PEEK or ABS.
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
The goal of this clinical trial is to analyze the usability and safety of the robotic gait device EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy.
Participants will use the exoskeletons in their home and the community and variables regarding safety and usability will be measured and recorded.
Read the detailed description
Neurological and neuromuscular diseases are the main cause of motor disability in children, leading to the inability to stand and walk in many cases. Robotic devices are a useful tool in the rehabilitation of these children, but most of them are designed to be used in the clinical setting. EXPLORER is a robotic device designed to assist gait in children with motor disability in their homes and the community. The aim of this study is to analyze the safety and usability of the EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy.
A test phase will be conducted in order to make some final modifications and improve the device. Some participants of the sample will use the device in 1-3 occasions in a controlled environment.
After these modifications, participants will use the final version of the device in 8 different occasions in their homes and the community in order to prove its safety and usability.
- Being tested
- EXPLORER
- Keywords
- cerebral palsy, acquired brain injury, spinal muscular atrophy, robotics, gait, rehabilitation
- Medical subject headings
- Cerebral Palsy, Brain Injuries, Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPLORERDevice
8 sessions of use of the device in the home and the community of the participants
| Study group | Role | What they receive |
|---|---|---|
| EXPLORER | Experimental | 8 sessions with the robotics gait device in their homes and natural environment for all participants Receives: Device: EXPLORER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Events
occurrence of any serious adverse event to the participant or the caregiver
Measured: through study completion, along 8 weeks
Falls prevalence
Number of falling events occurred from the participant or caregiver
Measured: through study completion, along 8 weeks
Skin integrity
Occurrence of any injury of the skin in the areas of contact and produced by the use of the device
Measured: through study completion, along 8 weeks
Pain (Visual Analogic Scale)
pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver, scored from 0 to 10, being 0 "no pain" and 10 "unbearable pain"
Measured: through study completion, along 8 weeks
Spasticity
spasticity measured by the Modified Ashworth Scale (MAS), scored from 0 (no spasticity) to 4 (affected part in rigid flexion or extension)
Measured: through study completion, along 8 weeks
Heart rate
measurement of heart rate
Measured: through study completion, along 8 weeks
Oxygen saturation
measurement of Oxygen saturation when medical prescription
Measured: through study completion, along 8 weeks
Donning and doffing time
Time to don and doff the device to each participant
Measured: through study completion, along 8 weeks
Number of steps
Number of steps taken provided by the device
Measured: through study completion, along 8 weeks
Walking time
Walking time provided by the device
Measured: through study completion, along 8 weeks
Interventions of the investigators
The number of times that the investigators have to intervene in the session in order to avoid damage when the device is being used by the caregiver
Measured: through study completion, along 8 weeks
Participant satisfaction
Satisfaction of the participant (caregiver) with the device measured by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0. (QUEST 2.0), scored with a Likert type scale from 0 to 5, being 0 the lowest satisfaction and 5 the highest possible satisfaction with the device
Measured: at the end of the intervention, 8th week
Blood pressure
measurement of blood pressure
Measured: through study completion, along 8 weeks
Secondary outcomes (4)
Acceptability
Analysis of the drop-out rate during the study period
Measured: at the end of the intervention, 8th week
Accessibility of the participant
Rate of the participants suitable to use the device
Measured: through study completion, along 8 weeks
Accessibility of the house
Rate of the houses suitable to use the device
Measured: through study completion, along 8 weeks
Accessibility of the exterior spaces
Rate of the exterior spaces that are suitable to use the device
Measured: through study completion, along 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start4 Dec 2023
- Primary completion17 Aug 2024
- Study completion17 Aug 2024
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- MarsiBionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Hospital Universitario La Paz, Hospital Universitario 12 de Octubre, Hospital General Universitario Gregorio Marañon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167954
- Sponsor's protocol ID
- EXP-I-US
- Status last verified
- Sep 2024
- First submitted
- 4 Dec 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Safety and Usability of a Robotic Gait Device for Children and Adolescents With Neurological or Neuromuscular Disease in Their Natural Environment
- ClinicalTrials.gov ID
- NCT06167954
- Acronym / sponsor ID
- EXP-I-US
- Keywords
- cerebral palsy, acquired brain injury, spinal muscular atrophy, robotics, gait, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- MarsiBionicsIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Hospital Universitario La Paz, Hospital Universitario 12 de Octubre, Hospital General Universitario Gregorio Marañon
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 17 Aug 2024 (actual)
- Study completion
- 17 Aug 2024 (actual)
- First posted
- 13 Dec 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.
The goal of this clinical trial is to analyze the usability and safety of the robotic gait device EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy.
Participants will use the exoskeletons in their home and the community and variables regarding safety and usability will be measured and recorded.
Detailed description
Neurological and neuromuscular diseases are the main cause of motor disability in children, leading to the inability to stand and walk in many cases. Robotic devices are a useful tool in the rehabilitation of these children, but most of them are designed to be used in the clinical setting. EXPLORER is a robotic device designed to assist gait in children with motor disability in their homes and the community. The aim of this study is to analyze the safety and usability of the EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy.
A test phase will be conducted in order to make some final modifications and improve the device. Some participants of the sample will use the device in 1-3 occasions in a controlled environment.
After these modifications, participants will use the final version of the device in 8 different occasions in their homes and the community in order to prove its safety and usability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXPLORER | Experimental | Device: EXPLORER8 sessions with the robotics gait device in their homes and natural environment for all participants |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Diagnosis of cerebral palsy, acquired brain injury or spinal muscular atrophy
- Medical authorization for standing, gait training and weight bearing.
- Informed consent signed by legal guardians.
- Maximum user weight of 60 kg.
- Hip width (between greater trochanters) ≤40 cm.
Key exclusion criteria (12 listed)
- Medical contraindications for standing or walking.
- Non-reducible contractures or heterotropic ossifications above the degrees allowed by the device or out of the trajectory imposed by the device
- 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 non-reducible contractures at the time of using the exoskeleton.
- Necessity to walk with more than 5º of hip abduction.
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 |
|---|---|---|
| EXPLORER8 sessions of use of the device in the home and the community of the participants | Device | EXPLORER |
Primary outcome
Serious Adverse Events
Time frame: through study completion, along 8 weeks
occurrence of any serious adverse event to the participant or the caregiver
Falls prevalence
Time frame: through study completion, along 8 weeks
Number of falling events occurred from the participant or caregiver
Skin integrity
Time frame: through study completion, along 8 weeks
Occurrence of any injury of the skin in the areas of contact and produced by the use of the device
Pain (Visual Analogic Scale)
Time frame: through study completion, along 8 weeks
pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver, scored from 0 to 10, being 0 "no pain" and 10 "unbearable pain"
Spasticity
Time frame: through study completion, along 8 weeks
spasticity measured by the Modified Ashworth Scale (MAS), scored from 0 (no spasticity) to 4 (affected part in rigid flexion or extension)
Heart rate
Time frame: through study completion, along 8 weeks
measurement of heart rate
Oxygen saturation
Time frame: through study completion, along 8 weeks
measurement of Oxygen saturation when medical prescription
Donning and doffing time
Time frame: through study completion, along 8 weeks
Time to don and doff the device to each participant
Number of steps
Time frame: through study completion, along 8 weeks
Number of steps taken provided by the device
Walking time
Time frame: through study completion, along 8 weeks
Walking time provided by the device
Interventions of the investigators
Time frame: through study completion, along 8 weeks
The number of times that the investigators have to intervene in the session in order to avoid damage when the device is being used by the caregiver
Participant satisfaction
Time frame: at the end of the intervention, 8th week
Satisfaction of the participant (caregiver) with the device measured by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0. (QUEST 2.0), scored with a Likert type scale from 0 to 5, being 0 the lowest satisfaction and 5 the highest possible satisfaction with the device
Blood pressure
Time frame: through study completion, along 8 weeks
measurement of blood pressure
4 secondary outcomes
Acceptability
Time frame: at the end of the intervention, 8th week
Accessibility of the participant
Time frame: through study completion, along 8 weeks
Accessibility of the house
Time frame: through study completion, along 8 weeks
Accessibility of the exterior spaces
Time frame: through study completion, along 8 weeks
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.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EXPLORER in people with Cerebral Palsy and Acquired Brain Injury, 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 8 inclusion and 12 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 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?
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?
Serious Adverse Events (time frame: through study completion, along 8 weeks). The study lists 13 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.