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Completed

NCT Number: NCT04837157

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Motor Neuron Disease Muscular Atrophy, Spinal Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases SMA II Spinal Cord Diseases Spinal Muscular Atrophies of Childhood

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MarsiCare

Arganda, Madrid, 28500, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exoskeleton rehabilitation

Device

The participants will perform physical therapy with the ATLSA2030 device, for 90 minutes per session.

Other names: ATLAS2030, ATLAS, robot-assisted therapy

Primary outcomes

  1. Safety as number of serious device adverse events

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

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

Secondary outcomes

  1. Safety as presence of adverse events or adverse device events

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

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

  2. Exercises [measured as time per exercise in seconds]

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

    Measured as time per event for at each therapy session.

  3. Transfers [measured as time to carry out the transfers in seconds]

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

    Measured as time to carry out the transfers

  4. Acceptability [number of participants which discontinue the participation during the trial in relation with the included participants]

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

    Measured as abandon ratio

  5. Accessibility [number of potential participants in relation with the included participants]

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

    Measured as relation between number of participants and number of potential participants which weren't recruited

  6. Fall Prevalence [number of falls during the using of the device]

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

    Number of falling events ocurred from the participant or therapist

  7. Skin integrity [number of skin injuries related to the device]

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

    skin integrity measured as the number of skin injuries

  8. Pain [Wong-Baker FACES Pain Rating Scale]

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

    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.

  9. Fatigue [Borg Rating Scale of Perceived Exertion]

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

    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.

  10. Spasticity [Modified Ashworth Scale]

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

    Spasticity registered before and after the use of the device

  11. Heart rate [sphygmomanometer]

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

    Number of heart bets per minute

  12. Physical evaluation [number of physical injuries detected]

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

    Physical Evaluation as presence of tissue damage

  13. Muscle Strength [measured with Hand Held Dynamometer in N]

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

    Muscle Strength measured at hip, knee and ankle muscles

  14. ROM [measured with goniometer]

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

    Range of Movement

  15. Functional Mobility [Functional Ambulation Category scale]

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

    Functional Mobility with and without the device

  16. System Usability [System Usability Scale]

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

    Measurement of System's Usability measured by the therapist

  17. User perception of the device [QUEST 2.0 and QUEST 2.1]

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

    QUEST 2.0 will be assessed by the therapist, and QUEST 2.1 will be assessed by the participant

  18. Distance covered walking [6MWT]

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

    6MWT recorded using the device

  19. Device malfunction [as number and type of device malfunction]

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

    Any device malfunction will be recorded

  20. Particpant's stability [Functional Reach Test]

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

    Functional Reach Test

  21. Systolic/Diastolic Pressure [sphygmomanometer]

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

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

  22. Breath Rate [number of breaths per minute]

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

    Number of breaths per minute

  23. SpO2 [pulse oximeter]

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

    SpO2 measured as %

Sponsors and collaborators

Lead sponsor

MarsiBionics

Industry

Collaborators

  • Hospital Universitario La Paz

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Apr 8, 2021
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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