Clinical trial NCT04837157: Evaluation of the Exoskeleton ATLAS 2030 as Robot-assisted Physical Therapy to Children With Neuromuscular Diseases
Official title: Evaluation of the Safety of ATLAS 2030 in the Application of Robot-assisted Physical Therapy to Children With Neuromuscular Diseases Phase I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
SMA II
Neuromuscular Diseases
Keywords: Exoskeleton
robot-assisted
physical therapy
ATLAS
Lead sponsor: MarsiBionics
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitario La Paz
First posted: 2021-04-08
Enrollment: 6
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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 rehabilitation sessions focused on walking and functional activities, with the expectation of evaluating the safety and usability of the device in the population studied. The protocol has been focused on defining how the device can be used appropriately in this population in a safe and effective manner by rehabilitation specialists. The study also aims to assess the safety of clinical staff who implement the intervention.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Safety as number of serious device adverse events
timeFrame: after each use of exoskeleton, for 5 weeks
Secondary outcomes:
measure: Safety as presence of adverse events or adverse device events
timeFrame: after each use of exoskeleton, for 5 weeks
measure: Exercises [measured as time per exercise in seconds]
timeFrame: after each use of exoskeleton, for 5 weeks
measure: Transfers [measured as time to carry out the transfers in seconds]
timeFrame: At each use of exoskeleton, for 5 weeks
measure: Acceptability [number of participants which discontinue the participation during the trial in relation with the included participants]
timeFrame: At the end of the study, at the 5th week
measure: Accessibility [number of potential participants in relation with the included participants]
timeFrame: At the end of the study, at the 5th week
measure: Fall Prevalence [number of falls during the using of the device]
timeFrame: During the use of the device, for 5 weeks
measure: Skin integrity [number of skin injuries related to the device]
timeFrame: before and after each use of exoskeleton, for 5 weeks
measure: Pain [Wong-Baker FACES Pain Rating Scale]
timeFrame: Before and after the use of the device, during 5 weeks
measure: Fatigue [Borg Rating Scale of Perceived Exertion]
timeFrame: Before and after the use of the device, during 5 weeks
measure: Spasticity [Modified Ashworth Scale]
timeFrame: Before and after the use of the device, during 5 weeks
measure: Heart rate [sphygmomanometer]
timeFrame: Before and after the use of the device, during 5 weeks
measure: Physical evaluation [number of physical injuries detected]
timeFrame: Before and after the use of the device, during 5 weeks
measure: Muscle Strength [measured with Hand Held Dynamometer in N]
timeFrame: At the first day, 3rd week and 5th week
measure: ROM [measured with goniometer]
timeFrame: At the first day, 3rd week and 5th week
measure: Functional Mobility [Functional Ambulation Category scale]
timeFrame: At the first day, 3rd week and 5th week
measure: System Usability [System Usability Scale]
timeFrame: At the end of the study, 5th week
measure: User perception of the device [QUEST 2.0 and QUEST 2.1]
timeFrame: At the end of the study, 5th week
measure: Distance covered walking [6MWT]
timeFrame: At the first day, 3rd week and 5th week
measure: Device malfunction [as number and type of device malfunction]
timeFrame: During the use of the device, for 5 weeks
measure: Particpant's stability [Functional Reach Test]
timeFrame: At the first day, 3rd week and 5th week
measure: Systolic/Diastolic Pressure [sphygmomanometer]
timeFrame: Before and after the use of the device, during 5 weeks
measure: Breath Rate [number of breaths per minute]
timeFrame: Before and after the use of the device, during 5 weeks
measure: SpO2 [pulse oximeter]
timeFrame: Before and after the use of the device, during 5 weeks
Other outcomes:
Locations:
city: Arganda Del Rey
country: Spain
facility: MarsiCare
state: Madrid
Study officials:
References:
citation: Cumplido-Trasmonte C, Ramos-Rojas J, Delgado-Castillejo E, Garces-Castellote E, Puyuelo-Quintana G, Destarac-Eguizabal MA, Barquin-Santos E, Plaza-Flores A, Hernandez-Melero M, Gutierrez-Ayala A, Martinez-Moreno M, Garcia-Armada E. Effects of ATLAS 2030 gait exoskeleton on strength and range of motion in children with spinal muscular atrophy II: a case series. J Neuroeng Rehabil. 2022 Jul 19;19(1):75. doi: 10.1186/s12984-022-01055-x.