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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cerebral Palsy, Acquired Brain Injury, Neuromuscular Diseases in Children

Intervention / Treatment
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* Device: EXPLORER V2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXPLORER V2<br>1 session with the exoskeleton EXPLORER V2 in healthy subjects 3 sessions with the exoskeleton EXPLORER V2 in subjects with disease | Device: EXPLORER V2<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exoskeleton, cerebral palsy, acquired brain injury, neuromuscular disease, gait, rehabilitation