Trials / Completed
CompletedNCT06167954
Safety and Usability of a Robotic Gait Device for Children and Adolescents With Neurological or Neuromuscular Disease in Their Natural Environment
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- MarsiBionics · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to analyze the usability and safety of the robotic gait device EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy. 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. Robotic devices are a useful tool in the rehabilitation of these children, but most of them are designed to be used in the clinical setting. EXPLORER is a robotic device 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 in children with cerebral palsy, acquired brain injury and spinal muscular atrophy. A test phase will be conducted in order to make some final modifications and improve the device. Some participants of the sample will use the device in 1-3 occasions in a controlled environment. After these modifications, participants will use the final version of the device in 8 different occasions in their homes and the community in order to prove its safety and usability.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | EXPLORER | 8 sessions of use of the device in the home and the community of the participants |
Timeline
- Start date
- 2023-12-04
- Primary completion
- 2024-08-17
- Completion
- 2024-08-17
- First posted
- 2023-12-13
- Last updated
- 2024-09-27
Locations
5 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT06167954. Inclusion in this directory is not an endorsement.