Status:
NOT_YET_RECRUITING
Safety and Usability of the EXPLORER Exoskeleton in Adults With Neuromuscular Diseases
Lead Sponsor:
MarsiBionics
Collaborating Sponsors:
Hospital Universitario La Paz
Conditions:
Neuromuscular Disorders
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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. EXPLORER is a...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT06894160
Start Date
July 1 2025
End Date
August 1 2025
Last Update
June 4 2025
Active Locations (1)
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1
Hospital Universitario La Paz
Madrid, Madrid, Spain, 28046