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

NCT05914818 | Completed DMC

• 1 other identifier: EXP-P-VAL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

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.

Conditions

Cerebral Palsy; Acquired Brain Injury; Neuromuscular Diseases in Children

Keywords

exoskeleton; cerebral palsy; acquired brain injury; neuromuscular disease; gait; rehabilitation

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (4)

• Acceptability

  At the end of the study, 6th week

• Accesssibility of the participant

  through study completion, along 6 weeks

• Accesssibility of the house

  through study completion, along 6 weeks

• Accesssibility of the exterior spaces

  through study completion, along 6 weeks

Study Arms (1)

EXPLORER V2

EXPERIMENTAL

1 session with the exoskeleton EXPLORER V2 in healthy subjects 3 sessions with the exoskeleton EXPLORER V2 in subjects with disease

Device: EXPLORER V2

Interventions

EXPLORER V2 DEVICE

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

EXPLORER V2

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• MarsiBionics: lead
• National Research Council, Spain: collaborator
• Hospital Infantil Universitario Niño Jesús, Madrid, Spain: collaborator
• Hospital Universitario La Paz: collaborator
• Hospital Universitario 12 de Octubre: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator

Study Sites (5)

Hospital Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación

Madrid, 28009, Spain

Location

Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia

Madrid, 28009, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Cerebral Palsy; Brain Injuries; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Olga Arroyo Riaño

  Hospital Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

• María Teresa Vara Arias

  Hospital Infantil Universitario Niño Jesús

  PRINCIPAL INVESTIGATOR

• Ignacio Martínez Caballero

  Hospital Infantil Universitario Niño Jesús

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 22, 2023
• Study Start: June 23, 2023
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: November 3, 2023

Record last verified: 2023-08

Locations

ES (5)