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

NCT04837157 | Completed

• 1 other identifier: ATLAS2030ENM-I
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy; SMA II; Neuromuscular Diseases

Keywords

Exoskeleton; robot-assisted; physical therapy; ATLAS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (23)

• Safety as presence of adverse events or adverse device events

  after each use of exoskeleton, for 5 weeks

• Exercises [measured as time per exercise in seconds]

  after each use of exoskeleton, for 5 weeks

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

  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]

  At the end of the study, at the 5th week

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

  At the end of the study, at the 5th week

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Interventions

Exoskeleton rehabilitation DEVICE

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

Also known as: ATLAS2030, ATLAS, robot-assisted therapy

Intervention Group

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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˚
• º or more hip flessum.
• º 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

You may not qualify if:

• Patient's inability to follow simple instructions and/or communicate discomfort.
• Invasive or non-invasive daytime ventilation.
• Orthostatic hypotension.
• º or more hip flessum.
• º 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.

Sponsors & Collaborators

• MarsiBionics: lead
• Hospital Universitario La Paz: collaborator

Study Sites (1)

MarsiCare

Arganda, Madrid, 28500, Spain

Location

Related Publications (1)

• 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.

  PMID: 35854321 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Spinal Muscular Atrophies of Childhood; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Atrophy, Spinal; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Motor Neuron Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: April 8, 2021
• Study Start: October 15, 2020
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

ES (1)