Clinical trial NCT05914818: Proof of Concept of Pediatric and Adolescent EXPLORER V2 Exoskeleton in Children With Neurological and Neuromuscular Disease
Official title: Proof of Concept of Pediatric and Adolescent EXPLORER V2 Exoskeleton in Children With Neurological and Neuromuscular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Acquired Brain Injury
Neuromuscular Diseases in Children
Keywords: exoskeleton
cerebral palsy
acquired brain injury
neuromuscular disease
gait
rehabilitation
Lead sponsor: MarsiBionics
Sponsor class: INDUSTRY
Collaborators: name: National Research Council, Spain
name: Hospital Infantil Universitario Niño Jesús, Madrid, Spain
name: Hospital Universitario La Paz
name: Hospital Universitario 12 de Octubre
name: Hospital General Universitario Gregorio Marañon
First posted: 2023-06-22
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serious Adverse Events
timeFrame: through study completion, along 6 weeks
measure: Falls prevalence
timeFrame: through study completion, along 6 weeks
measure: Skin integrity
timeFrame: through study completion, along 6 weeks
measure: Pain (Visual Analogic Scale)
timeFrame: through study completion, along 6 weeks
measure: Spasticity
timeFrame: through study completion, along 6 weeks
measure: Kinematic data during gait
timeFrame: Once, during the first session with the exoskeleton
measure: Donning and doffing time
timeFrame: through study completion, along 6 weeks
measure: Heart rate
timeFrame: through study completion, along 6 weeks
measure: Blood pressure
timeFrame: through study completion, along 6 weeks
measure: Oxygen saturation
timeFrame: through study completion, along 6 weeks
measure: Participant satisfaction
timeFrame: at the end of the intervention, 6th week
measure: Number of steps
timeFrame: through study completion, along 6 weeks
measure: Walking time
timeFrame: through study completion, along 6 weeks
measure: Interventions of the investigators
timeFrame: through study completion, along 6 weeks
Secondary outcomes:
measure: Acceptability
timeFrame: At the end of the study, 6th week
measure: Accesssibility of the participant
timeFrame: through study completion, along 6 weeks
measure: Accesssibility of the house
timeFrame: through study completion, along 6 weeks
measure: Accesssibility of the exterior spaces
timeFrame: through study completion, along 6 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación
city: Madrid
country: Spain
facility: Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Universitario Gregorio Marañón
name: Olga Arroyo Riaño
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Infantil Universitario Niño Jesús
name: María Teresa Vara Arias
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Infantil Universitario Niño Jesús
name: Ignacio Martínez Caballero
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Univsersitario La Paz
name: Sandra Espinosa García
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital 12 de Octubre
name: Sofía García de las Peñas
role: PRINCIPAL_INVESTIGATOR
affiliation: National Research Council, Spain
name: Elena García Armada
role: PRINCIPAL_INVESTIGATOR
affiliation: Marsi Bionics S L
name: Eva Barquín Santos
role: PRINCIPAL_INVESTIGATOR
References: