Clinical trial NCT06167954: Safety and Usability of a Robotic Gait Device for Children and Adolescents With Neurological or Neuromuscular Disease in Their Natural Environment
Official title: Safety and Usability of a Robotic Gait Device for Children and Adolescents With Neurological or Neuromuscular Disease in Their Natural Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Acquired Brain Injury
Spinal Muscular Atrophy
Keywords: cerebral palsy
acquired brain injury
spinal muscular atrophy
robotics
gait
rehabilitation
Lead sponsor: MarsiBionics
Sponsor class: INDUSTRY
Collaborators: 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: 2023-12-13
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
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 robotic gait device EXPLORER in children with cerebral palsy, acquired brain injury and spinal muscular atrophy.

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. Robotic devices are a useful tool in the rehabilitation of these children, but most of them are designed to be used in the clinical setting. EXPLORER is a robotic device 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 in children with cerebral palsy, acquired brain injury and spinal muscular atrophy.

A test phase will be conducted in order to make some final modifications and improve the device. Some participants of the sample will use the device in 1-3 occasions in a controlled environment.

After these modifications, participants will use the final version of the device in 8 different occasions in their homes and the community in order to prove its safety and usability.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cerebral palsy, acquired brain injury or spinal muscular atrophy
* Medical authorization for standing, gait training and weight bearing.
* Informed consent signed by legal guardians.
* Maximum user weight of 60 kg.
* Hip width (between greater trochanters) ≤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 ≤40 (EU)

Exclusion Criteria:

* Medical contraindications for standing or walking.
* Non-reducible contractures or heterotropic ossifications above the degrees allowed by the device or out of the trajectory imposed by the device
* 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 non-reducible contractures at the time of using the exoskeleton.
* Necessity to walk with more than 5º of hip abduction.
* Impossibility to reach 5º of ankle dorsiflexion with ir without orthoses.
* Lower length dysmetria that cannot be mitigated with a wedge under the foot.
* Skin lesion on parts of the lower extremities that are in contact with the device.
* History of fracture without trauma.
* 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.
* 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 8 weeks
measure: Falls prevalence
timeFrame: through study completion, along 8 weeks
measure: Skin integrity
timeFrame: through study completion, along 8 weeks
measure: Pain (Visual Analogic Scale)
timeFrame: through study completion, along 8 weeks
measure: Spasticity
timeFrame: through study completion, along 8 weeks
measure: Heart rate
timeFrame: through study completion, along 8 weeks
measure: Oxygen saturation
timeFrame: through study completion, along 8 weeks
measure: Donning and doffing time
timeFrame: through study completion, along 8 weeks
measure: Number of steps
timeFrame: through study completion, along 8 weeks
measure: Walking time
timeFrame: through study completion, along 8 weeks
measure: Interventions of the investigators
timeFrame: through study completion, along 8 weeks
measure: Participant satisfaction
timeFrame: at the end of the intervention, 8th week
measure: Blood pressure
timeFrame: through study completion, along 8 weeks
Secondary outcomes:
measure: Acceptability
timeFrame: at the end of the intervention, 8th week
measure: Accessibility of the participant
timeFrame: through study completion, along 8 weeks
measure: Accessibility of the house
timeFrame: through study completion, along 8 weeks
measure: Accessibility of the exterior spaces
timeFrame: through study completion, along 8 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:
References: