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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04837157
• Other study ID #: ATLAS2030ENM-I
• Status: Completed
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: April 2021
• Source: MarsiBionics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Neuromuscular Diseases
• SMA II

Intervention

Device:
• Exoskeleton rehabilitation
The participants will perform physical therapy with the ATLSA2030 device, for 90 minutes per session.

Locations

Country	Name	City	State
Spain	MarsiCare	Arganda Del Rey	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
MarsiBionics	Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Heart rate [sphygmomanometer]	Number of heart bets per minute	Before and after the use of the device, during 5 weeks
Secondary	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
Secondary	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
Secondary	ROM [measured with goniometer]	Range of Movement	At the first day, 3rd week and 5th week
Secondary	Functional Mobility [Functional Ambulation Category scale]	Functional Mobility with and without the device	At the first day, 3rd week and 5th week
Secondary	System Usability [System Usability Scale]	Measurement of System's Usability measured by the therapist	At the end of the study, 5th week
Secondary	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
Secondary	Distance covered walking [6MWT]	6MWT recorded using the device	At the first day, 3rd week and 5th week
Secondary	Device malfunction [as number and type of device malfunction]	Any device malfunction will be recorded	During the use of the device, for 5 weeks
Secondary	Particpant's stability [Functional Reach Test]	Functional Reach Test	At the first day, 3rd week and 5th week
Secondary	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
Secondary	Breath Rate [number of breaths per minute]	Number of breaths per minute	Before and after the use of the device, during 5 weeks
Secondary	SpO2 [pulse oximeter]	SpO2 measured as %	Before and after the use of the device, during 5 weeks