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

MarsiBionics6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Cerebral Palsy SMA II Neuromuscular Diseases

Interventions

Eligibility

Sex: ALLMin age: 3 YearsMax age: 14 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Safety as number of serious device adverse events

Presence of a serious device adverse events where the participant or therapist is involved

Time frame: after each use of exoskeleton, for 5 weeks

Secondary Outcomes

Safety as presence of adverse events or adverse device events

Presence of a device adverse events where the participant or therapist is involved.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: Before and after the use of the device, during 5 weeks

Heart rate [sphygmomanometer]

Number of heart bets per minute

Time frame: 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

Time frame: 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

Time frame: At the first day, 3rd week and 5th week

ROM [measured with goniometer]

Range of Movement

Time frame: At the first day, 3rd week and 5th week

Functional Mobility [Functional Ambulation Category scale]

Functional Mobility with and without the device

Time frame: At the first day, 3rd week and 5th week

System Usability [System Usability Scale]

Measurement of System's Usability measured by the therapist

Time frame: 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

Time frame: At the end of the study, 5th week

Distance covered walking [6MWT]

6MWT recorded using the device

Time frame: At the first day, 3rd week and 5th week

Device malfunction [as number and type of device malfunction]

Any device malfunction will be recorded

Time frame: During the use of the device, for 5 weeks

Particpant's stability [Functional Reach Test]

Functional Reach Test

Time frame: At the first day, 3rd week and 5th week

Systolic/Diastolic Pressure [sphygmomanometer]

Systolic Pressure and Diastolic Pressure measured with sphygmomanometer (measured in mmHg)

Time frame: Before and after the use of the device, during 5 weeks

Breath Rate [number of breaths per minute]

Number of breaths per minute

Time frame: Before and after the use of the device, during 5 weeks

SpO2 [pulse oximeter]

SpO2 measured as %

Time frame: Before and after the use of the device, during 5 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes