Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2026-02-25 @ 11:04 PM
Study NCT ID:
NCT06894160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Usability of the EXPLORER Exoskeleton in Adults With Neuromuscular Diseases
Sponsor:
MarsiBionics
Organization:
Study Overview
Official Title:
Safety and Usability of Adults EXPLORER Exoskeleton in With Neuromuscular Diseases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: