NCT06765070

Efficacy and Usability of the EXPLORER Exoskeleton in Children With Neurodevelopmental Disorders in Natural Environments

Efficacy and Usability of the EXPLORER Exoskeleton in Children With Neurodevelopmental Disorders in Their Natural Environment

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: MarsiBionics · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Neurodevelopmental disorders often lead to abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as an inability to stand and walk. EXPLORER is a robotic gait exoskeleton designed to rehabilitate children with motor disabilities in home and outdoor environments. The aim of this study is to evaluate the efficacy and usability of EXPLORER in children with motor disability within their natural settings, including home and community environments.

Detailed description

Neurodevelopmental disorders often lead to abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as an inability to stand and walk. 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 evaluate the efficacy and usability of EXPLORER in children with motor disability within their natural settings, including home and community environments. An initial session will be conducted in the participant's natural environment, during which the researchers will instruct the primary caregivers on the use of the device. Subsequently, the device will be left for a two-month period for use in the natural settings deemed appropriate by the family.

Conditions

• Neuromuscular Disorders
• Neurodevelopmental Disorders

Interventions

Type	Name	Description
DEVICE	EXPLORER	Two-week period with the robotics gait device for use in the natural settings deemed appropriate by the family.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-04-01
• Completion: 2025-12-01
• First posted: 2025-01-09
• Last updated: 2025-09-25

Locations

6 sites across 1 country: Spain