Clinical trial NCT06765070: Efficacy and Usability of the EXPLORER Exoskeleton in Children With Neurodevelopmental Disorders in Natural Environments
Official title: Efficacy and Usability of the EXPLORER Exoskeleton in Children With Neurodevelopmental Disorders in Their Natural Environment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neuromuscular Disorders
Neurodevelopmental Disorders
Keywords: Neurodevelopmental disorders
Neuromuscular disorders
cerebral palsy
acquired brain injury
spinal muscular atrophy
robotics
gait
rehabilitation
spinal cord injury
Lead sponsor: MarsiBionics
Sponsor class: INDUSTRY
Collaborators: name: Hospital Infantil Universitario Niño Jesús, Madrid, Spain
name: Hospital General Universitario Gregorio Marañon
name: Hospital Universitario La Paz
name: Hospital Universitario 12 de Octubre
name: Universidad Rey Juan Carlos
First posted: 2025-01-09
Enrollment: 15
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: Neurodevelopmental disorders often lead to abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as an inability to stand and walk. EXPLORER is a robotic gait exoskeleton designed to rehabilitate children with motor disabilities in home and outdoor environments.

The aim of this study is to evaluate the efficacy and usability of EXPLORER in children with motor disability within their natural settings, including home and community environments.

Detailed description: Neurodevelopmental disorders often lead to abnormal development of the Central Nervous System (CNS), frequently causing motor dysfunctions such as an inability to stand and walk. 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 evaluate the efficacy and usability of EXPLORER in children with motor disability within their natural settings, including home and community environments.

An initial session will be conducted in the participant's natural environment, during which the researchers will instruct the primary caregivers on the use of the device. Subsequently, the device will be left for a two-week period for use in the natural settings deemed appropriate by the family.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of any pathology or condition causing neurodevelopmental disorders.
* Ability to continuously use the device for two weeks, at least 3 times per week, without causing excessive fatigue that would prevent the participant from carrying out their usual activities.
* Availability and commitment from the family to use the device at least 3 times per week during the planned period, in different environments and with various objectives.
* 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) ≤37 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 2 weeks
measure: Falls prevalence
timeFrame: through study completion, along 2 weeks
measure: Skin integrity
timeFrame: through study completion, along 2 weeks
measure: Pain (Visual Analogic Scale)
timeFrame: through study completion, along 2 weeks
measure: Donning and doffing time
timeFrame: through study completion, along 2 weeks
measure: Device usage time
timeFrame: through study completion, along 2 weeks
measure: Number of steps
timeFrame: through study completion, along 2 weeks
measure: Usage modes
timeFrame: through study completion, along 2 weeks
measure: Speed
timeFrame: through study completion, along 2 weeks
measure: Device accessibility
timeFrame: through study completion, along 2 weeks
measure: Range of motion
timeFrame: Before starting the intervention (S1) and after completing the two weeks of use
measure: Participation
timeFrame: Before starting the intervention (S1) and after completing the two weeks of use
Secondary outcomes:
measure: QUEST
timeFrame: at the end of the intervention
Other outcomes:
Locations:
city: Alcorcon
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
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 Infantil Universitario Niño Jesús-Servicio de Neuro Ortopedia
city: Madrid
country: Spain
facility: Hospital Universitario 12 Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
References: