Proof of Concept of Pediatric and Adolescent EXPLORER V2 Exoskeleton in Children With Neurological and Neuromuscular Disease

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.

Conditions

• Cerebral Palsy
• Acquired Brain Injury
• Neuromuscular Diseases in Children

Interventions

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

Sponsors & Collaborators

• National Research Council, Spain

  collaborator OTHER_GOV

• Hospital Infantil Universitario Niño Jesús, Madrid, Spain

  collaborator OTHER

• Hospital Universitario La Paz

  collaborator OTHER

• Hospital Universitario 12 de Octubre

  collaborator OTHER

• Hospital General Universitario Gregorio Marañon

  collaborator OTHER

• MarsiBionics

  lead INDUSTRY

Principal Investigators

• Olga Arroyo Riaño · Hospital Universitario Gregorio Marañón

• María Teresa Vara Arias · Hospital Infantil Universitario Niño Jesús

• Ignacio Martínez Caballero · Hospital Infantil Universitario Niño Jesús

• Sandra Espinosa García · Hospital Univsersitario La Paz

• Sofía García de las Peñas · Hospital 12 de Octubre

• Elena García Armada · National Research Council, Spain

• Eva Barquín Santos · Marsi Bionics S L

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

2 Years

Max Age

14 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-23

Primary Completion

2023-09-29

Completion

2023-09-29

Countries

• Spain

Study Locations