Neuromuscular DisordersNCT06894160
Safety and Usability of the EXPLORER Exoskeleton in Adults With Neuromuscular Diseases
A study testing Adults EXPLORER in people with Neuromuscular Disorders, run by MarsiBionics at 1 site in Spain.
Trial summary
Neurodevelopmental disorders frequently result in abnormal development of the Central Nervous System (CNS), often leading to motor impairments such as difficulty in standing and walking. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Disorders
- What is being tested?
- Adults EXPLORER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Weight < 100 kg.
- Hip width between 30 - 45 cm.
- Distance from the hip joint center to the knee joint center: 36 cm - 50 cm.
- Distance from the knee joint center to the floor: 43.5 cm - 59.5 cm.
- Patients must be able to follow simple instructions.
- MAS < 3 in lower limbs.
Show all 13Show fewer
- EU shoe size between 36 and 45.
- Absence of pathology affecting movement (only valid for phase 1 of the current study).
- Age 18-85 years.
- Diagnosis of stroke (ACV), acquired brain injury (DCA), multiple sclerosis (EM), muscular dystrophy (LM), or cerebral palsy (PC).
- Gait difficulty: those who require assistance to walk using technical aids, assistance, or supervision from others.
- FAC score in participants with DCA, stroke, or MS < 4.
- WISCI II score in participants with MD < 20.
Who cannot join
- Spasticity (MAS) = 3 in lower limbs.
- Skin alterations in the areas of contact with the device.
- Planned surgical intervention during the study duration.
- Two or more osteoporotic fractures in the lower limbs in the last 2 years.
- Presence of other conditions that cause exercise intolerance (such as uncontrolled hypertension, coronary artery diseases, arrhythmia, congestive heart failure, severe lung disease).
- Surgical operation in the 3 months prior to the start of the study on the limbs and/or spine.
- Psychiatric disorders that interfere with proper use of the device or participation in the study, such as impulsivity or inability to understand simple instructions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Universitario La Paz
Madrid, Madrid, 28046
David Hernández Herrero, 679645714, dhernandez.herrero@salud.madrid.org
About this study
Official title: Safety and Usability of Adults EXPLORER Exoskeleton in With Neuromuscular Diseases
Neurodevelopmental disorders frequently result in abnormal development of the Central Nervous System (CNS), often leading to motor impairments such as difficulty in standing and walking. EXPLORER is a robotic exoskeleton for gait rehabilitation, specifically designed for adults aged 18 to 85 with motor disabilities.The aim of this study is to evaluate the safety and usability of the EXPLORER for adults with motor disability.
Read the detailed description
Neurodevelopmental disorders frequently result in abnormal development of the Central Nervous System (CNS), often leading to motor impairments such as difficulty in standing and walking. EXPLORER is a robotic exoskeleton for gait rehabilitation, specifically designed for adults aged 18 to 85 with motor disabilities. The aim of this study is to evaluate the safety and usability of the EXPLORER for adults with motor disability.
This study will involve testing the gait-assistance exoskeleton in healthy patients during the first phase, and in patients with stroke (ACV), acquired brain injury (DCA), multiple sclerosis (EM), and muscular dystrophy (LM) during the second phase. The study will consist of two phases:
Phase 1: One visit with the device in healthy patients to assess the initial safety and comfort of the device.
Phase 2: A screening visit (S0) followed by two treatment visits with the device (V1-V2) in patients with ACV, DCA, EM, and LM to determine the effectiveness of the device in treating motor impairments caused by these conditions.
The goal of the study is to evaluate the safety and usability of the device in patients with ACV, DCA, EM, and LM, in order to identify potential benefits in improving gait, muscle strength, and overall functionality in this patient group.
- Conditions
- Neuromuscular Disorders
- Being tested
- Adults EXPLORER
- Keywords
- gait, robotics, neuromuscular disorders, rehabilitation
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adults EXPLORERDevice
Two sessions with the robotic gait device in patients with neuromuscular diseases.
| Study group | Role | What they receive |
|---|---|---|
| Adults EXPLORER | Experimental | Two sessions with the robotic gait device in patients with neuromuscular diseases. Receives: Device: Adults 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, an average of 1 month
Falls prevalence
Number of falling events occurred from the participant or caregiver
Measured: Through study completion, an average of 1 month
Heart Rate
Beats per minute
Measured: Through study completion, an average of 1 month
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, an average of 1 month
Device usage time
Time using the device
Measured: Through study completion, an average of 1 month
Level of Spasticity
Evaluation of spasticity with Modified Ahsworth Scale
Measured: Through study completion, an average of 1 month
Level of fatigue
Fatigue of both the participant and the therapist, Measured with the Borg scale
Measured: Through study completion, an average of 1 month
Donning and doffing time
Time to don and doff the device to each participant
Measured: Through study completion, an average of 1 month
Level of assistance a participant requires for walking
Measure with FAC scale
Measured: Through study completion, an average of 1 month
Walking ability of individuals with spinal cord injuries
Measure with WISCII (SCI) scale
Measured: Through study completion, an average of 1 month
TUG
The Time Up and Go test is used to assess a participant's mobility and balance
Measured: Through study completion, an average of 1 month
10MWT
The 10-Meter Walk Test is used to assess walking speed by measuring the time taken to walk 10 meters at a comfortable pace.
Measured: Through study completion, an average of 1 month
QUEST 2.0
Using the Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire administered to the participants' caregivers at the end of the intervention. The QUEST 2.0 scale has 12 items. Each item is rated on a 5-point Likert scale
Measured: at the end of the intervention, an average of 1 month
Blood Pressure
Measure in mmHg
Measured: Through study completion, an average of 1 month
Oxygen Saturation
It analyzes this absorption and calculates the SpO₂
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 Jul 2025 (estimated)
- Primary completion15 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DisordersStudies 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
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MarsiBionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario La Paz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894160
- Sponsor's protocol ID
- EXP-A-US
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 4 Jun 2025
- 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 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Usability of Adults EXPLORER Exoskeleton in With Neuromuscular Diseases
- ClinicalTrials.gov ID
- NCT06894160
- Acronym / sponsor ID
- EXP-A-US
- Conditions
- Neuromuscular Disorders
- Keywords
- gait, robotics, neuromuscular disorders, rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- MarsiBionicsIndustry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario La Paz
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 15 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 25 Mar 2025 (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.
Neurodevelopmental disorders frequently result in abnormal development of the Central Nervous System (CNS), often leading to motor impairments such as difficulty in standing and walking. EXPLORER is a robotic exoskeleton for gait rehabilitation, specifically designed for adults aged 18 to 85 with motor disabilities.The aim of this study is to evaluate the safety and usability of the EXPLORER for adults with motor disability.
Detailed description
Neurodevelopmental disorders frequently result in abnormal development of the Central Nervous System (CNS), often leading to motor impairments such as difficulty in standing and walking. EXPLORER is a robotic exoskeleton for gait rehabilitation, specifically designed for adults aged 18 to 85 with motor disabilities. The aim of this study is to evaluate the safety and usability of the EXPLORER for adults with motor disability.
This study will involve testing the gait-assistance exoskeleton in healthy patients during the first phase, and in patients with stroke (ACV), acquired brain injury (DCA), multiple sclerosis (EM), and muscular dystrophy (LM) during the second phase. The study will consist of two phases:
Phase 1: One visit with the device in healthy patients to assess the initial safety and comfort of the device.
Phase 2: A screening visit (S0) followed by two treatment visits with the device (V1-V2) in patients with ACV, DCA, EM, and LM to determine the effectiveness of the device in treating motor impairments caused by these conditions.
The goal of the study is to evaluate the safety and usability of the device in patients with ACV, DCA, EM, and LM, in order to identify potential benefits in improving gait, muscle strength, and overall functionality in this patient group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults EXPLORER | Experimental | Device: Adults EXPLORERTwo sessions with the robotic gait device in patients with neuromuscular diseases. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Weight < 100 kg.
- Hip width between 30 - 45 cm.
- Distance from the hip joint center to the knee joint center: 36 cm - 50 cm.
- Distance from the knee joint center to the floor: 43.5 cm - 59.5 cm.
- Patients must be able to follow simple instructions.
Key exclusion criteria (7 listed)
- Spasticity (MAS) = 3 in lower limbs.
- Skin alterations in the areas of contact with the device.
- Planned surgical intervention during the study duration.
- Two or more osteoporotic fractures in the lower limbs in the last 2 years.
- Presence of other conditions that cause exercise intolerance (such as uncontrolled hypertension, coronary artery diseases, arrhythmia, congestive heart failure, severe lung disease).
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 |
|---|---|---|
| Adults EXPLORERTwo sessions with the robotic gait device in patients with neuromuscular diseases. | Device | Adults EXPLORER |
Primary outcome
Serious Adverse Events
Time frame: Through study completion, an average of 1 month
Occurrence of any serious adverse event to the participant or the caregiver
Falls prevalence
Time frame: Through study completion, an average of 1 month
Number of falling events occurred from the participant or caregiver
Heart Rate
Time frame: Through study completion, an average of 1 month
Beats per minute
Skin integrity
Time frame: Through study completion, an average of 1 month
Occurrence of any injury of the skin in the areas of contact and produced by the use of the device
Device usage time
Time frame: Through study completion, an average of 1 month
Time using the device
Level of Spasticity
Time frame: Through study completion, an average of 1 month
Evaluation of spasticity with Modified Ahsworth Scale
Level of fatigue
Time frame: Through study completion, an average of 1 month
Fatigue of both the participant and the therapist, Measured with the Borg scale
Donning and doffing time
Time frame: Through study completion, an average of 1 month
Time to don and doff the device to each participant
Level of assistance a participant requires for walking
Time frame: Through study completion, an average of 1 month
Measure with FAC scale
Walking ability of individuals with spinal cord injuries
Time frame: Through study completion, an average of 1 month
Measure with WISCII (SCI) scale
TUG
Time frame: Through study completion, an average of 1 month
The Time Up and Go test is used to assess a participant's mobility and balance
10MWT
Time frame: Through study completion, an average of 1 month
The 10-Meter Walk Test is used to assess walking speed by measuring the time taken to walk 10 meters at a comfortable pace.
QUEST 2.0
Time frame: at the end of the intervention, an average of 1 month
Using the Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire administered to the participants' caregivers at the end of the intervention. The QUEST 2.0 scale has 12 items. Each item is rated on a 5-point Likert scale
Blood Pressure
Time frame: Through study completion, an average of 1 month
Measure in mmHg
Oxygen Saturation
Time frame: Through study completion, an average of 1 month
It analyzes this absorption and calculates the SpO₂
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adults EXPLORER in people with Neuromuscular Disorders, run by MarsiBionics at 1 site 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 13 inclusion and 7 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: opening soon, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carlos Cumplido Trasmonte (+34918711900, carlos.cumplido@marsibionics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events (time frame: Through study completion, an average of 1 month). The study lists 15 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 4 Jun 2025.