Status:
COMPLETED
Evaluation of the Exoskeleton ATLAS 2030 as Robot-assisted Physical Therapy to Children With Neuromuscular Diseases
Lead Sponsor:
MarsiBionics
Collaborating Sponsors:
Hospital Universitario La Paz
Conditions:
Cerebral Palsy
SMA II
Eligibility:
All Genders
3-14 years
Phase:
NA
Brief Summary
This study aims to evaluate the safety, usability and acceptability of a motorized mobility assistance exoskeleton. The protocol explores the use of the motorized device during static and dynamic reha...
Eligibility Criteria
Inclusion
- Maximum user weight of 35 kg
- Thigh length (distance from the greater trochanter to the lateral condyle of the tibia) from 24 cm to 40 cm.
- Leg length (distance from the lateral condyle of the tibia to the lateral malleolus) from 23 to 39 cm.
- Pelvis width (between greater trochanters) from 24 to 35 cm.
- Ability to achieve ankle dorsiflexion to 90˚
- 20º or more hip flessum.
- 20º or more knee flessum.
- No allergies to any of the ATLAS materials: cotton, nylon, polyester, polyamide, polyethylene or propylene.
- Informed consent signed by legal guardians.
- Confirmed diagnosis of cerebral palsy or neuromuscular disease affecting walking ability at early development stages
- Stable medical condition with no changes in disease-specific medication in the last 6 months, and additional medication in the last month.
- Patient being followed according to the recommended standards for his or her illness
- Ability to maintain, spontaneously or with a brace, the head and trunk while standing and walking.
- No need for daytime ventilation (have an oxygen saturation and PCO2 with normal ambient oxygen
- Score on the FAC scale between 1 and 4 points
- Not being able to walk without assistance
Exclusion
- Patient's inability to follow simple instructions and/or communicate discomfort.
- Invasive or non-invasive daytime ventilation.
- Orthostatic hypotension.
- 20º or more hip flessum.
- 20º or more knee flessum
- Scoliosis with a Cobb angle of more than 25º that cannot wear a corset during the test.
- Severe skin injury to the lower extremities.
- Scheduled surgery (spine, extremities) during the period of the study or surgery performed (spine, extremities) in the last 6 months.
- History of fracture without trauma.
- History of traumatic bone fracture in lower limbs or pelvic girdle in the last 3 months
- Not receiving regular standing rehabilitation sessions.
- Absence of control of the head or trunk in an upright position without the possibility of wearing a corset during the use of the exoskeleton
- Refusal of the patient or legal guardian to include the child in the study.
- Skin problems (diseases, allergies, sensitivity ...) that prevent the use of exoskeleton accessories on the skin of patients.
Key Trial Info
Start Date :
October 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04837157
Start Date
October 15 2020
End Date
January 31 2021
Last Update
April 8 2021
Active Locations (1)
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1
MarsiCare
Arganda, Madrid, Spain, 28500