Acquired Brain Injury, Cerebral Palsy, Neuromuscular Diseases in Children
Conditions
Keywords
exoskeleton, cerebral palsy, acquired brain injury, neuromuscular disease, gait, rehabilitation
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.
Interventions
DEVICEEXPLORER 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
Sponsors
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
MarsiBionics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 14 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interventions of the investigators | through study completion, along 6 weeks | 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 |
| Oxygen saturation | through study completion, along 6 weeks | measurement of Oxygen saturation when medical prescription |
| Participant satisfaction | at the end of the intervention, 6th week | Satisfaction of the participant (caregiver) with the devicem measured by the Quebec User Evaluation of Satisfaction with Assistive Technology 2.0. |
| Number of steps | through study completion, along 6 weeks | Number of steps taken with the exoskeleton provided by the device |
| Walking time | through study completion, along 6 weeks | Walking time while using the exoskeleton provided by the device |
| Serious Adverse Events | through study completion, along 6 weeks | occurrence of any serious adverse event to the participant or the caregiver |
| Falls prevalence | through study completion, along 6 weeks | Number of falling events ocurred from the participant or caregiver |
| Skin integrity | through study completion, along 6 weeks | Ocurrence of any injury of the skin in the areas of contact and produced by the use of the exoskeleton |
| Pain (Visual Analogic Scale) | through study completion, along 6 weeks | pain measured by the Visual Analogic Scale (VAS) by the participant and the caregiver |
| Spasticity | through study completion, along 6 weeks | spasticity measured by the Modified Ashworth Scale (MAS) |
| Kinematic data during gait | Once, during the first session with the exoskeleton | 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 | through study completion, along 6 weeks | Time to don and doff the device to each participant |
| Heart rate | through study completion, along 6 weeks | measurement of heart rate when medical prescription |
| Blood pressure | through study completion, along 6 weeks | measurement of blood pressure when medical prescription |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Accesssibility of the participant | through study completion, along 6 weeks | Rate of the participants suitable to use the device |
| Accesssibility of the house | through study completion, along 6 weeks | Rate of the houses suitable to use the device |
| Accesssibility of the exterior spaces | through study completion, along 6 weeks | Rate of the exterior spaces that are suitable to use the device |
| Acceptability | At the end of the study, 6th week | Analysis of the drop-out rate during the study period |
Countries
Spain
Outcome results
None listed