NCT06167954Completed
Safety and Usability of a Robotic Gait Device for Children and Adolescents With Neurological or Neuromuscular Disease in Their Natural Environment
Source: ClinicalTrials.gov · Last updated 27 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 4 Dec 2023
- Start date
- 4 Dec 2023
- Primary completion date
- 17 Aug 2024
- Lead sponsor
- MarsiBionics
- Diseases
- Spinal muscular atrophy
- NCT number
- NCT06167954
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 4 Dec 2023 to the primary completion date, 17 Aug 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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)
Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Infantil Universitario Niño Jesús - Servicio de Rehabilitación Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Niño Jesús-Servicio de Neuro Ortopedia Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.