Clinical trial NCT06894160: Safety and Usability of the EXPLORER Exoskeleton in Adults With Neuromuscular Diseases
Official title: Safety and Usability of Adults EXPLORER Exoskeleton in With Neuromuscular Diseases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neuromuscular Disorders
Keywords: gait
robotics
neuromuscular disorders
rehabilitation
Lead sponsor: MarsiBionics
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitario La Paz
First posted: 2025-03-25
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serious Adverse Events
timeFrame: Through study completion, an average of 1 month
measure: Falls prevalence
timeFrame: Through study completion, an average of 1 month
measure: Heart Rate
timeFrame: Through study completion, an average of 1 month
measure: Skin integrity
timeFrame: Through study completion, an average of 1 month
measure: Device usage time
timeFrame: Through study completion, an average of 1 month
measure: Level of Spasticity
timeFrame: Through study completion, an average of 1 month
measure: Level of fatigue
timeFrame: Through study completion, an average of 1 month
measure: Donning and doffing time
timeFrame: Through study completion, an average of 1 month
measure: Level of assistance a participant requires for walking
timeFrame: Through study completion, an average of 1 month
measure: Walking ability of individuals with spinal cord injuries
timeFrame: Through study completion, an average of 1 month
measure: TUG
timeFrame: Through study completion, an average of 1 month
measure: 10MWT
timeFrame: Through study completion, an average of 1 month
measure: QUEST 2.0
timeFrame: at the end of the intervention, an average of 1 month
measure: Blood Pressure
timeFrame: Through study completion, an average of 1 month
measure: Oxygen Saturation
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References: