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

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

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 Overview

• Status: Completed
• Conditions: Cerebral Palsy; Neuromuscular Diseases; SMA II
• Intervention / Treatment: Device: Exoskeleton rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Arganda Del Rey, Madrid, Spain, 28500
      • MarsiCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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; The participants will perform physical therapy with the ATLSA2030 device, for 90 minutes per session.; Other Names: ATLAS2030; ATLAS; robot-assisted therapy

What is the study measuring?

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
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
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
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
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
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
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
Heart rate [sphygmomanometer]	Number of heart bets per minute	Before and after the use of the device, during 5 weeks
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
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

Collaborators and Investigators

• Sponsor: MarsiBionics
• Collaborators: Hospital Universitario La Paz

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Exoskeleton; physical therapy; ATLAS; robot-assisted
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Neuromuscular Diseases
• Other Study ID Numbers: ATLAS2030ENM-I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No