Back to resultsProof of Concept of Pediatric and Adolescent EXPLORER V2 Exoskeleton in Children With Neurological and Neuromuscular Disease
Primary Purpose
Cerebral Palsy, Acquired Brain Injury, Neuromuscular Diseases in Children
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
EXPLORER V2
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring exoskeleton, cerebral palsy, acquired brain injury, neuromuscular disease, gait, rehabilitation
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.
Sites / Locations
- Hospital Universitario Gregorio Marañón
- Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación
- Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia
- Hospital Universitario 12 de Octubre
- Hospital Universitario La Paz
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
EXPLORER V2
Arm Description
1 session with the exoskeleton EXPLORER V2 in healthy subjects 3 sessions with the exoskeleton EXPLORER V2 in subjects with disease
Outcomes
Primary Outcome Measures
Serious Adverse Events
occurrence of any serious adverse event to the participant or the caregiver
Falls prevalence
Number of falling events ocurred from the participant or caregiver
Skin integrity
Ocurrence of any injury of the skin in the areas of contact and produced by the use of the exoskeleton
Pain (Visual Analogic Scale)
pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver
Spasticity
spasticity measured by the Modified Ashworth Scale (MAS)
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
Donning and doffing time
Time to don and doff the device to each participant
Heart rate
measurement of heart rate when medical prescription
Blood pressure
measurement of blood pressure when medical prescription
Oxygen saturation
measurement of Oxygen saturation when medical prescription
Participant satisfaction
Satisfaction of the participant (caregiver) with the devicem measured by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0.
Number of steps
Number of steps taken with the exoskeleton provided by the device
Walking time
Walking time while using the exoskeleton provided by the device
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
Secondary Outcome Measures
Acceptability
Analysis of the drop-out rate during the study period
Accesssibility of the participant
Rate of the participants suitable to use the device
Accesssibility of the house
Rate of the houses suitable to use the device
Accesssibility of the exterior spaces
Rate of the exterior spaces that are suitable to use the device
Full Information
NCT ID
NCT05914818
First Posted
May 30, 2023
Last Updated
August 16, 2023
Sponsor
MarsiBionics
Collaborators
National Research Council, Spain, Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Hospital Universitario La Paz, Hospital Universitario 12 de Octubre, Hospital General Universitario Gregorio Marañon
1. Study Identification
Unique Protocol Identification Number
NCT05914818
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 23, 2023 (Actual)
Primary Completion Date
September 29, 2023 (Anticipated)
Study Completion Date
September 29, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MarsiBionics
Collaborators
National Research Council, Spain, Hospital Infantil Universitario Niño Jesús, Madrid, Spain, Hospital Universitario La Paz, Hospital Universitario 12 de Octubre, Hospital General Universitario Gregorio Marañon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Acquired Brain Injury, Neuromuscular Diseases in Children
Keywords
exoskeleton, cerebral palsy, acquired brain injury, neuromuscular disease, gait, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EXPLORER V2
Arm Type
Experimental
Arm Description
1 session with the exoskeleton EXPLORER V2 in healthy subjects 3 sessions with the exoskeleton EXPLORER V2 in subjects with disease
Intervention Type
Device
Intervention Name(s)
EXPLORER V2
Intervention Description
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
Primary Outcome Measure Information:
Title
Serious Adverse Events
Description
occurrence of any serious adverse event to the participant or the caregiver
Time Frame
through study completion, along 6 weeks
Title
Falls prevalence
Description
Number of falling events ocurred from the participant or caregiver
Time Frame
through study completion, along 6 weeks
Title
Skin integrity
Description
Ocurrence of any injury of the skin in the areas of contact and produced by the use of the exoskeleton
Time Frame
through study completion, along 6 weeks
Title
Pain (Visual Analogic Scale)
Description
pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver
Time Frame
through study completion, along 6 weeks
Title
Spasticity
Description
spasticity measured by the Modified Ashworth Scale (MAS)
Time Frame
through study completion, along 6 weeks
Title
Kinematic data during gait
Description
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
Time Frame
Once, during the first session with the exoskeleton
Title
Donning and doffing time
Description
Time to don and doff the device to each participant
Time Frame
through study completion, along 6 weeks
Title
Heart rate
Description
measurement of heart rate when medical prescription
Time Frame
through study completion, along 6 weeks
Title
Blood pressure
Description
measurement of blood pressure when medical prescription
Time Frame
through study completion, along 6 weeks
Title
Oxygen saturation
Description
measurement of Oxygen saturation when medical prescription
Time Frame
through study completion, along 6 weeks
Title
Participant satisfaction
Description
Satisfaction of the participant (caregiver) with the devicem measured by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0.
Time Frame
at the end of the intervention, 6th week
Title
Number of steps
Description
Number of steps taken with the exoskeleton provided by the device
Time Frame
through study completion, along 6 weeks
Title
Walking time
Description
Walking time while using the exoskeleton provided by the device
Time Frame
through study completion, along 6 weeks
Title
Interventions of the investigators
Description
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
Time Frame
through study completion, along 6 weeks
Secondary Outcome Measure Information:
Title
Acceptability
Description
Analysis of the drop-out rate during the study period
Time Frame
At the end of the study, 6th week
Title
Accesssibility of the participant
Description
Rate of the participants suitable to use the device
Time Frame
through study completion, along 6 weeks
Title
Accesssibility of the house
Description
Rate of the houses suitable to use the device
Time Frame
through study completion, along 6 weeks
Title
Accesssibility of the exterior spaces
Description
Rate of the exterior spaces that are suitable to use the device
Time Frame
through study completion, along 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Arroyo Riaño
Organizational Affiliation
Hospital Universitario Gregorio Marañón
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
María Teresa Vara Arias
Organizational Affiliation
Hospital Infantil Universitario Niño Jesús
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ignacio Martínez Caballero
Organizational Affiliation
Hospital Infantil Universitario Niño Jesús
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra Espinosa García
Organizational Affiliation
Hospital Univsersitario La Paz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sofía García de las Peñas
Organizational Affiliation
Hospital 12 de Octubre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elena García Armada
Organizational Affiliation
National Research Council, Spain
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eva Barquín Santos
Organizational Affiliation
Marsi Bionics S L
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Infantil Universitario Niño Jesús-Servicio de Rehabilitación
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Proof of Concept of Pediatric and Adolescent EXPLORER V2 Exoskeleton in Children With Neurological and Neuromuscular Disease
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