Cerebral PalsyNCT05914818

Proof of Concept of Pediatric and Adolescent EXPLORER V2 Exoskeleton in Children With Neurological and Neuromuscular Disease

A study testing EXPLORER V2 in people with Cerebral Palsy and Acquired Brain Injury, run by MarsiBionics at 5 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to analyze the usability and safety of the prototype gait exoskeleton EXPLORE V2 in children with neurological and neuromuscular disease. Participants will use the exoskeletons in their home and the community and variables regarding safety and usability will be measured and recorded. Read more about this study

Who is it for?: Ages 2 to 14 yearsHealthy volunteers can take part
Conditions the study is for: Cerebral Palsy, Acquired Brain Injury, Neuromuscular Diseases in Children
What is being tested?: EXPLORER V2
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 5 sitesSpain
Study dates: 23 Jun 2023to 29 Sep 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 2 to 14 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Medical authorization for standing, gait training and weight bearing.
Informed consent signed by legal guardians.
Maximum user weight of 35 kg.
Hip width (between greater trochanteres) ≤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 ≤38 (EU)

Who cannot join

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 15 of hip abduction.
Skin lesion on parts of the lower extremities that are in contact with the device.
Scheduled surgery scheduled during the study period.
History of fracture without trauma. History of bone fracture traumatic in lower extremities or pelvic girdle in the last 3 months.

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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 or the inability to understand simple comands.
Allergy to any of the EXPLORER materials: cotton, nylon, polyester, PPS, PEEK or ABS.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

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

Other trials in Spain

About this study

The goal of this clinical trial is to analyze the usability and safety of the prototype gait exoskeleton EXPLORE V2 in children with neurological and neuromuscular disease.

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. Exoskeletons are a useful tool in the rehabilitation of these children, but most of them are designed to be used in the clinical setting. EXPLORER V2 is a prototype of a robotic gait exoskeleton 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 V2 as a proof of concept.

A test phase will be conducted in healthy volunteers (phase 0) as a proof of concept with the aim of evaluating safety and usability in healthy participants prior to the use of the device in children with neurological and neuromuscular disease (phases 1 and 2). After this, participants will use the exoskeleton in 4 different ocassions, 1 in a laboratory of gait analysis and 3 in their homes and the community.

Conditions: Cerebral Palsy, Acquired Brain Injury, Neuromuscular Diseases in Children
Being tested: EXPLORER V2
Keywords: exoskeleton, cerebral palsy, acquired brain injury, neuromuscular disease, gait, rehabilitation
Medical subject headings: Cerebral Palsy, Brain Injuries, Neuromuscular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EXPLORER V2Device
4 sessions of use of the exoskeleton, 1 in a laboratory of gait analysis and 3 in the home and the community of the participants

Study groups in NCT05914818
Study group	Role	What they receive
EXPLORER V2	Experimental	1 session with the exoskeleton EXPLORER V2 in healthy subjects 3 sessions with the exoskeleton EXPLORER V2 in subjects with disease Receives: Device: EXPLORER V2

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 6 weeks
Falls prevalence
Number of falling events ocurred from the participant or caregiver
Measured: through study completion, along 6 weeks
Skin integrity
Ocurrence of any injury of the skin in the areas of contact and produced by the use of the exoskeleton
Measured: through study completion, along 6 weeks
Pain (Visual Analogic Scale)
pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver
Measured: through study completion, along 6 weeks
Spasticity
spasticity measured by the Modified Ashworth Scale (MAS)
Measured: through study completion, along 6 weeks
Kinematic data during gait
Kinematic values for each joint of the lower limb during gait, assessed by photogrammetry in a gait analysis laboratory both in healthy subjects and participants with disease
Measured: Once, during the first session with the exoskeleton
Donning and doffing time
Time to don and doff the device to each participant
Measured: through study completion, along 6 weeks
Heart rate
measurement of heart rate when medical prescription
Measured: through study completion, along 6 weeks
Blood pressure
measurement of blood pressure when medical prescription
Measured: through study completion, along 6 weeks
Oxygen saturation
measurement of Oxygen saturation when medical prescription
Measured: through study completion, along 6 weeks
Participant satisfaction
Satisfaction of the participant (caregiver) with the devicem measured by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0.
Measured: at the end of the intervention, 6th week
Number of steps
Number of steps taken with the exoskeleton provided by the device
Measured: through study completion, along 6 weeks
Walking time
Walking time while using the exoskeleton provided by the device
Measured: through study completion, along 6 weeks
Interventions of the investigators
The amount 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 6 weeks

Secondary outcomes (4)

Acceptability
Analysis of the drop-out rate during the study period
Measured: At the end of the study, 6th week
Accesssibility of the participant
Rate of the participants suitable to use the device
Measured: through study completion, along 6 weeks
Accesssibility of the house
Rate of the houses suitable to use the device
Measured: through study completion, along 6 weeks
Accesssibility of the exterior spaces
Rate of the exterior spaces that are suitable to use the device
Measured: through study completion, along 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jun 202329 Sep 2023

First posted22 Jun 2023
Study start23 Jun 2023
Primary completion29 Sep 2023
Study completion29 Sep 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05914818
Sponsor's protocol ID: EXP-P-VAL
Status last verified: Aug 2023
First submitted: 30 May 2023
Last updated: 3 Nov 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cerebral Palsy trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Proof of Concept of Pediatric and Adolescent EXPLORER V2 Exoskeleton in Children With Neurological and Neuromuscular Disease
ClinicalTrials.gov ID: NCT05914818
Acronym / sponsor ID: EXP-P-VAL
Conditions: Cerebral Palsy, Acquired Brain Injury, Neuromuscular Diseases in Children
Keywords: exoskeleton, cerebral palsy, acquired brain injury, neuromuscular disease, gait, rehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
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: 23 Jun 2023 (actual)
Primary completion: 29 Sep 2023 (actual)
Study completion: 29 Sep 2023 (actual)
First posted: 22 Jun 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 prototype gait exoskeleton EXPLORE V2 in children with neurological and neuromuscular disease.

Participants will use the exoskeletons in their home and the community and variables regarding safety and usability will be measured and recorded.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
EXPLORER V2	Experimental	Device: EXPLORER V21 session with the exoskeleton EXPLORER V2 in healthy subjects 3 sessions with the exoskeleton EXPLORER V2 in subjects with disease

Who may qualify

Ages: 2 to 14 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

Medical authorization for standing, gait training and weight bearing.
Informed consent signed by legal guardians.
Maximum user weight of 35 kg.
Hip width (between greater trochanteres) ≤40 cm.
Length of the thigh (distance from the greater trochanter to the lateral condyle of the tibia) from 21cm to 36cm.

Key exclusion criteria (9 listed)

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 15 of hip abduction.
Skin lesion on parts of the lower extremities that are in contact with the device.
Scheduled surgery scheduled during the study period.

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
EXPLORER V24 sessions of use of the exoskeleton, 1 in a laboratory of gait analysis and 3 in the home and the community of the participants	Device	EXPLORER V2

Primary outcome

Serious Adverse Events
Time frame: through study completion, along 6 weeks
occurrence of any serious adverse event to the participant or the caregiver
Falls prevalence
Time frame: through study completion, along 6 weeks
Number of falling events ocurred from the participant or caregiver
Skin integrity
Time frame: through study completion, along 6 weeks
Ocurrence of any injury of the skin in the areas of contact and produced by the use of the exoskeleton
Pain (Visual Analogic Scale)
Time frame: through study completion, along 6 weeks
pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver
Spasticity
Time frame: through study completion, along 6 weeks
spasticity measured by the Modified Ashworth Scale (MAS)
Kinematic data during gait
Time frame: Once, during the first session with the exoskeleton
Kinematic values for each joint of the lower limb during gait, assessed by photogrammetry in a gait analysis laboratory both in healthy subjects and participants with disease
Donning and doffing time
Time frame: through study completion, along 6 weeks
Time to don and doff the device to each participant
Heart rate
Time frame: through study completion, along 6 weeks
measurement of heart rate when medical prescription
Blood pressure
Time frame: through study completion, along 6 weeks
measurement of blood pressure when medical prescription
Oxygen saturation
Time frame: through study completion, along 6 weeks
measurement of Oxygen saturation when medical prescription
Participant satisfaction
Time frame: at the end of the intervention, 6th week
Satisfaction of the participant (caregiver) with the devicem measured by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0.
Number of steps
Time frame: through study completion, along 6 weeks
Number of steps taken with the exoskeleton provided by the device
Walking time
Time frame: through study completion, along 6 weeks
Walking time while using the exoskeleton provided by the device
Interventions of the investigators
Time frame: through study completion, along 6 weeks
The amount 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

4 secondary outcomes

Acceptability
Time frame: At the end of the study, 6th week
Accesssibility of the participant
Time frame: through study completion, along 6 weeks
Accesssibility of the house
Time frame: through study completion, along 6 weeks
Accesssibility of the exterior spaces
Time frame: through study completion, along 6 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 3 Nov 2023.

Related trials for Cerebral Palsy

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Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
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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?

A study testing EXPLORER V2 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 7 inclusion and 9 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 3 Nov 2023. 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 6 weeks). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05914818.

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 3 Nov 2023.