Hospital Universitario La Paz
Madrid, 28046, Spain
Not Yet Recruiting
NCT Number: NCT06894160
Safety and Usability of the EXPLORER Exoskeleton in Adults 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.
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Trial opening soon.
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Age range
18 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
related to the device characteristics:
- 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.
- EU shoe size between 36 and 45.
- Absence of pathology affecting movement (only valid for phase 1 of the current study).
Inclusion criteria
related to the 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.
Exclusion criteria
- 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.
Treatment and study plan
Adults EXPLORER
DeviceTwo sessions with the robotic gait device in patients with neuromuscular diseases.
Primary outcomes
-
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
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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
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Level of assistance a participant requires for walking
Time frame: Through study completion, an average of 1 month
Measure with FAC scale
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Walking ability of individuals with spinal cord injuries
Time frame: Through study completion, an average of 1 month
Measure with WISCII (SCI) scale
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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
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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
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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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
MarsiBionics
Industry
Collaborators
- Hospital Universitario La Paz
Registry information
Official study title
Safety and Usability of Adults EXPLORER Exoskeleton in With Neuromuscular Diseases
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Mar 25, 2025
- Registry last updated
- Jun 4, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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