Trials / Completed
CompletedNCT05914818
Proof of Concept of Pediatric and Adolescent EXPLORER V2 Exoskeleton in Children With Neurological and Neuromuscular Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- MarsiBionics · Industry
- Sex
- All
- Age
- 2 Years – 14 Years
- Healthy volunteers
- Accepted
Summary
The goal of this clinical trial is to analyze the usability and safety of the prototype gait exoskeleton EXPLORE V2 in children with neurological and neuromuscular disease. Participants will use the exoskeletons in their home and the community and variables regarding safety and usability will be measured and recorded.
Detailed description
Neurological and neuromuscular diseases are the main cause of motor disability in children, leading to the inability to stand and walk in many cases. Exoskeletons are a useful tool in the rehabilitation of these children, but most of them are designed to be used in the clinical setting. EXPLORER V2 is a prototype of a robotic gait exoskeleton designed to assist gait in children with motor disability in their homes and the community. The aim of this study is to analyze the safety and usability of the EXPLORER V2 as a proof of concept. A test phase will be conducted in healthy volunteers (phase 0) as a proof of concept with the aim of evaluating safety and usability in healthy participants prior to the use of the device in children with neurological and neuromuscular disease (phases 1 and 2). After this, participants will use the exoskeleton in 4 different ocassions, 1 in a laboratory of gait analysis and 3 in their homes and the community.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EXPLORER V2 | 4 sessions of use of the exoskeleton, 1 in a laboratory of gait analysis and 3 in the home and the community of the participants |
Timeline
- Start date
- 2023-06-23
- Primary completion
- 2023-09-29
- Completion
- 2023-09-29
- First posted
- 2023-06-22
- Last updated
- 2023-11-03
Locations
5 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT05914818. Inclusion in this directory is not an endorsement.