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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Acquired Brain Injury; Neuromuscular Diseases in Children
• Intervention / Treatment: Device: EXPLORER V2

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eva Barquín Santos; Phone Number: +34918711900; Email: eva.barquin@marsibionics.com

Study Locations

• Spain
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28007
    • Hospital Universitario Gregorio Marañón
  • Madrid, Spain, 28009
    • Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación
  • Madrid, Spain, 28009
    • Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Medical authorization for standing, gait training and weight bearing.
• Informed consent signed by legal guardians.
• Maximum user weight of 35 kg.
• Hip width (between greater trochanteres) ≤40 cm.
• Length of the thigh (distance from the greater trochanter to the lateral condyle of the tibia) from 21cm to 36cm.
• Tibia leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 20cm to 35cm.
• Shoe size ≤38 (EU)

Exclusion Criteria:

• Spasticity equal to 4 on the Modified Ashworth Scale at the time of use of the device.
• More than 20º of hip and/or knee flessum at the time of using the exoskeleton.
• Necessity to walk with 15 of hip abduction.
• Skin lesion on parts of the lower extremities that are in contact with the device.
• Scheduled surgery scheduled during the study period.
• History of fracture without trauma. History of bone fracture traumatic in lower extremities or pelvic girdle in the last 3 months.
• Presence of other conditions causing exercise intolerance (such as uncontrolled hypertension, coronary artery disease, arrhythmia, congestive heart failure, severe pulmonary disease).
• Conductual disorders that may interfere with the use of the device or their participation in the study, like impulsiveness or the inability to understand simple comands.
• Allergy to any of the EXPLORER materials: cotton, nylon, polyester, PPS, PEEK or ABS.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXPLORER V2; 1 session with the exoskeleton EXPLORER V2 in healthy subjects 3 sessions with the exoskeleton EXPLORER V2 in subjects with disease	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious Adverse Events	occurrence of any serious adverse event to the participant or the caregiver	through study completion, along 6 weeks
Falls prevalence	Number of falling events ocurred from the participant or caregiver	through study completion, along 6 weeks
Skin integrity	Ocurrence of any injury of the skin in the areas of contact and produced by the use of the exoskeleton	through study completion, along 6 weeks
Pain (Visual Analogic Scale)	pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver	through study completion, along 6 weeks
Spasticity	spasticity measured by the Modified Ashworth Scale (MAS)	through study completion, along 6 weeks
Kinematic data during gait	Kinematic values for each joint of the lower limb during gait, assessed by photogrammetry in a gait analysis laboratory both in healthy subjects and participants with disease	Once, during the first session with the exoskeleton
Donning and doffing time	Time to don and doff the device to each participant	through study completion, along 6 weeks
Heart rate	measurement of heart rate when medical prescription	through study completion, along 6 weeks
Blood pressure	measurement of blood pressure when medical prescription	through study completion, along 6 weeks
Oxygen saturation	measurement of Oxygen saturation when medical prescription	through study completion, along 6 weeks
Participant satisfaction	Satisfaction of the participant (caregiver) with the devicem measured by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0.	at the end of the intervention, 6th week
Number of steps	Number of steps taken with the exoskeleton provided by the device	through study completion, along 6 weeks
Walking time	Walking time while using the exoskeleton provided by the device	through study completion, along 6 weeks
Interventions of the investigators	The amount of times that the investigators have to intervene in the session in order to avoid damage when the device is being used by the caregiver	through study completion, along 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Analysis of the drop-out rate during the study period	At the end of the study, 6th week
Accesssibility of the participant	Rate of the participants suitable to use the device	through study completion, along 6 weeks
Accesssibility of the house	Rate of the houses suitable to use the device	through study completion, along 6 weeks
Accesssibility of the exterior spaces	Rate of the exterior spaces that are suitable to use the device	through study completion, along 6 weeks

Collaborators and Investigators

• Sponsor: MarsiBionics
• Collaborators: Hospital General Universitario Gregorio Marañon; Hospital Infantil Universitario Niño Jesús, Madrid, Spain; Hospital Universitario 12 de Octubre; National Research Council, Spain; Hospital Universitario La Paz
• Investigators: Principal Investigator: Olga Arroyo Riaño, Hospital Universitario Gregorio Marañón; Principal Investigator: María Teresa Vara Arias, Hospital Infantil Universitario Nino Jesus; Principal Investigator: Ignacio Martínez Caballero, Hospital Infantil Universitario Nino Jesus; Principal Investigator: Sandra Espinosa García, Hospital Univsersitario La Paz; Principal Investigator: Sofía García de las Peñas, Hospital 12 de Octubre; Principal Investigator: Elena García Armada, National Research Council, Spain; Principal Investigator: Eva Barquín Santos, Marsi Bionics S L

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: gait; rehabilitation; cerebral palsy; exoskeleton; acquired brain injury; neuromuscular disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Brain Damage, Chronic; Craniocerebral Trauma; Trauma, Nervous System; Cerebral Palsy; Brain Injuries; Neuromuscular Diseases
• Other Study ID Numbers: EXP-P-VAL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No