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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Two sessions with the robotic gait device in patients with neuromuscular diseases.
Hospital Universitario La Paz
Madrid, Madrid, Spain
Serious Adverse Events
Occurrence of any serious adverse event to the participant or the caregiver
Time frame: Through study completion, an average of 1 month
Falls prevalence
Number of falling events occurred from the participant or caregiver
Time frame: Through study completion, an average of 1 month
Heart Rate
Beats per minute
Time frame: 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
Time frame: Through study completion, an average of 1 month
Device usage time
Time using the device
Time frame: Through study completion, an average of 1 month
Level of Spasticity
Evaluation of spasticity with Modified Ahsworth Scale
Time frame: Through study completion, an average of 1 month
Level of fatigue
Fatigue of both the participant and the therapist, Measured with the Borg scale
Time frame: Through study completion, an average of 1 month
Donning and doffing time
Time to don and doff the device to each participant
Time frame: Through study completion, an average of 1 month
Level of assistance a participant requires for walking
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Measure with FAC scale
Time frame: Through study completion, an average of 1 month
Walking ability of individuals with spinal cord injuries
Measure with WISCII (SCI) scale
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: at the end of the intervention, an average of 1 month
Blood Pressure
Measure in mmHg
Time frame: Through study completion, an average of 1 month
Oxygen Saturation
It analyzes this absorption and calculates the SpO₂
Time frame: Through study completion, an average of 1 month