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

NCT ID: NCT04837157

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2021-01-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Exoskeleton rehabilitation

Intervention Type: DEVICE

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

Interventions

Exoskeleton rehabilitation

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

Intervention Type: DEVICE

Other Intervention Names

ATLAS2030; ATLAS; robot-assisted therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario La Paz

OTHER

Sponsor Role: collaborator

MarsiBionics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MarsiCare

Arganda, Madrid, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 35854321 (View on PubMed)

Other Identifiers

ATLAS2030ENM-I

Identifier Type: -

Identifier Source: org_study_id