Status:
COMPLETED
Rehabilitative Effect of the Use of a Gait Exoskeleton in Patients With Neuromuscular Disease or Cerebral Palsy
Lead Sponsor:
MarsiBionics
Collaborating Sponsors:
Hospital Universitario La Paz
National Research Council, Spain
Conditions:
Neuromuscular Diseases
Cerebral Palsy
Eligibility:
All Genders
3-14 years
Phase:
NA
Brief Summary
The purpose of this multicentric study is to assess the rehabilitative effect derived from the use of the ATLAS exoskeleton in children with neuromuscular diseases or cerebral palsy and with a level o...
Detailed Description
The objectives of the study are: * Objective 1: To assess the safety and physical and physiological tolerance of the child to the activity performed with the exoskeleton in the rehabilitation session...
Eligibility Criteria
Inclusion
- Children with neuromuscular disease or cerebral palsy who have gait disturbance or no gait.
- Children between 3 and 14 years of age.
Exclusion
- Weight\> 35 kg
- Femoral length (from the axis of the hip joint in the sagittal plane to the axis of the knee joint in the same plane) \<23 cm or \>38 cm for size M and from 31 cm to 40 cm for size L
- Stem length (from the axis of the knee joint in the sagittal plane to the axis of the ankle joint in the same plane) \<23 or \>32 cm for size M and from or \>39 cm for size L
- Distance between great trochanters \<24 or \>35 cm for size M and \<25 cm or \>35 cm for size L
- Inability to understand simple commands, to cooperate actively in therapy, or inability to express basic needs
- Spasticity measured with the Modified Ashworth Scale greater than or equal to 3 in the lower limbs
- Scoliosis \> 25° without the possibility of wearing a brace
- Skin alteration where direct contact between the patient's skin and the exoskeleton is not recommended
- Limitation of passive range of motion at the knee or hip joint \> 20 degrees
- Osteoporosis that may induce a bone fracture when low intensity physical activity is performed
- Any other medical condition that may be a risk to the patient's safety and well-being in relation to low intensity physical exercise
Key Trial Info
Start Date :
March 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04813601
Start Date
March 9 2020
End Date
September 24 2023
Last Update
October 26 2023
Active Locations (1)
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1
MarsiCare
Arganda, Madrid, Spain, 28500