Evaluation of the Exoskeleton ATLAS 2030 as Robot-assisted Physical Therapy to Children With Neuromuscular Diseases

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Safety of ATLAS 2030 in the Application of Robot-assisted Physical Therapy to Children With Neuromuscular Diseases Phase I

Conditions
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Cerebral Palsy, SMA II, Neuromuscular Diseases

Intervention / Treatment
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* Device: Exoskeleton rehabilitation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>9 treatment sessions will be performed with the ATLAS2030 exoskeleton. The rehabilitation sessions last approximately 90 minutes. Two sessions are scheduled per week, for two weeks. | Device: Exoskeleton rehabilitation<br>* The participants will perform physical therapy with the ATLSA2030 device, for 90 minutes per session.<br>* Other names: robot-assisted therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as number of serious device adverse events | Presence of a serious device adverse events where the participant or therapist is involved | after each use of exoskeleton, for 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as presence of adverse events or adverse device events | Presence of a device adverse events where the participant or therapist is involved. | after each use of exoskeleton, for 5 weeks | 
| Exercises [measured as time per exercise in seconds] | Measured as time per event for at each therapy session. | after each use of exoskeleton, for 5 weeks | 
| Transfers [measured as time to carry out the transfers in seconds] | Measured as time to carry out the transfers | At each use of exoskeleton, for 5 weeks | 
| Acceptability [number of participants which discontinue the participation during the trial in relation with the included participants] | Measured as abandon ratio | At the end of the study, at the 5th week | 
| Accessibility [number of potential participants in relation with the included participants] | Measured as relation between number of participants and number of potential participants which weren't recruited | At the end of the study, at the 5th week | 
| Fall Prevalence [number of falls during the using of the device] | Number of falling events ocurred from the participant or therapist | During the use of the device, for 5 weeks | 
| Skin integrity [number of skin injuries related to the device] | skin integrity measured as the number of skin injuries | before and after each use of exoskeleton, for 5 weeks | 
| Pain [Wong-Baker FACES Pain Rating Scale] | Pain registered before and after the use of the device, by the participant and therapist. The options are from 1 to 6. A higher score means a worse outcome. | Before and after the use of the device, during 5 weeks | 
| Fatigue [Borg Rating Scale of Perceived Exertion] | Fatigue registered before and after the use of the device, by the participant and therapist. Measured from 0 to 10, being 0 as fully rested and 10 very tired. A higher score means a worse outcome. | Before and after the use of the device, during 5 weeks | 
| Spasticity [Modified Ashworth Scale] | Spasticity registered before and after the use of the device | Before and after the use of the device, during 5 weeks | 
| Heart rate [sphygmomanometer] | Number of heart bets per minute | Before and after the use of the device, during 5 weeks | 
| Physical evaluation [number of physical injuries detected] | Physical Evaluation as presence of tissue damage | Before and after the use of the device, during 5 weeks | 
| Muscle Strength [measured with Hand Held Dynamometer in N] | Muscle Strength measured at hip, knee and ankle muscles | At the first day, 3rd week and 5th week | 
| ROM [measured with goniometer] | Range of Movement | At the first day, 3rd week and 5th week | 
| Functional Mobility [Functional Ambulation Category scale] | Functional Mobility with and without the device | At the first day, 3rd week and 5th week | 
| System Usability [System Usability Scale] | Measurement of System's Usability measured by the therapist | At the end of the study, 5th week | 
| User perception of the device [QUEST 2.0 and QUEST 2.1] | QUEST 2.0 will be assessed by the therapist, and QUEST 2.1 will be assessed by the participant | At the end of the study, 5th week | 
| Distance covered walking [6MWT] | 6MWT recorded using the device | At the first day, 3rd week and 5th week | 
| Device malfunction [as number and type of device malfunction] | Any device malfunction will be recorded | During the use of the device, for 5 weeks | 
| Particpant's stability [Functional Reach Test] | Functional Reach Test | At the first day, 3rd week and 5th week | 
| Systolic/Diastolic Pressure [sphygmomanometer] | Systolic Pressure and Diastolic Pressure measured with sphygmomanometer (measured in mmHg) | Before and after the use of the device, during 5 weeks | 
| Breath Rate [number of breaths per minute] | Number of breaths per minute | Before and after the use of the device, during 5 weeks | 
| SpO2 [pulse oximeter] | SpO2 measured as % | Before and after the use of the device, during 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exoskeleton, robot-assisted, physical therapy, ATLAS