Rehabilitative Effect of the Use of a Gait Exoskeleton in Patients With Neuromuscular Disease or Cerebral Palsy

Marsi Bionics

Status: Completed

Conditions: SMA II; Neuromuscular Diseases; Cerebral Palsy

Treatments: Device: ATLAS 2030

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04813601

ATLAS2030CLI-I

Details and patient eligibility

About

The purpose of this multicentric study is to assess the rehabilitative effect derived from the use of the ATLAS exoskeleton in children with neuromuscular diseases or cerebral palsy and with a level of less than 3 or less in the Functional Ambulation Classification (FAC) as a consequence of their disease, as well as the assessment of other physical, functional and quality of life parameters of interest. For this purpose, the exoskeleton will be used as a rehabilitation and walking assistance tool.

Before starting the study programme and if deemed necessary, a preliminary phase consisting of 1 to 3 sessions will be carried out during which the patient will be shown the exoskeleton for the first time and it will be considered whether any improvements to the different parts of the device or the software are necessary to increase the ergonomics and comfort of the patient.

Full description

The objectives of the study are:

• Objective 1: To assess the safety and physical and physiological tolerance of the child to the activity performed with the exoskeleton in the rehabilitation sessions.
• Objective 2:
• To assess the safety of a progressive treatment algorithm to achieve the safe progression of patients throughout the therapy
• To assess whether an improvement is achieved in parameters related to the physical rehabilitation of the patient using the exoskeleton, in respiratory capacity, self-perceived quality of life (physical and emotional well-being and self-esteem) as well as to assess the effectiveness of a psychological intervention to provide support in coping with the situation of using the device for the first time in those children who have not used it before.

The time period of the study will be as long as necessary to reach the desired number of participants, in this case 10 children (N=10). The participants will be patients affected by neuromuscular diseases or cerebral palsy and will be selected on the basis of the following inclusion/exclusion criteria:

Inclusion criteria: 1. Children with neuromuscular disease or cerebral palsy who present gait disturbances or no gait disturbance. 2. Children between 3 and 11 years of age.

Exclussion criteria: not fulfil the usage criteria of the device.

Enrollment: 10 patients

Sex: All

Ages: 3 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children with neuromuscular disease or cerebral palsy who have gait disturbance or no gait.
• Children between 3 and 14 years of age.

Exclusion criteria

• Weight> 35 kg
• Femoral length (from the axis of the hip joint in the sagittal plane to the axis of the knee joint in the same plane) <23 cm or >38 cm for size M and from 31 cm to 40 cm for size L
• Stem length (from the axis of the knee joint in the sagittal plane to the axis of the ankle joint in the same plane) <23 or >32 cm for size M and from or >39 cm for size L
• Distance between great trochanters <24 or >35 cm for size M and <25 cm or >35 cm for size L
• Inability to understand simple commands, to cooperate actively in therapy, or inability to express basic needs
• Spasticity measured with the Modified Ashworth Scale greater than or equal to 3 in the lower limbs
• Scoliosis > 25° without the possibility of wearing a brace
• Skin alteration where direct contact between the patient's skin and the exoskeleton is not recommended
• Limitation of passive range of motion at the knee or hip joint > 20 degrees
• Osteoporosis that may induce a bone fracture when low intensity physical activity is performed
• Any other medical condition that may be a risk to the patient's safety and well-being in relation to low intensity physical exercise

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Robot Asissted Gait Training

Experimental group

Description:

The rehabilitation sessions will be carried out by a physiotherapist trained in rehabilitation with the ATLAS 2030 exoskeleton and will also have the technical supervision of personnel specialised in the handling of the laboratory and the robotic device.

Treatment:

Device: ATLAS 2030