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

NCT ID: NCT04813601

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-09
• Study Completion Date: 2023-09-24

Brief Summary

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.

Detailed 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.

Conditions

Neuromuscular Diseases; Cerebral Palsy; SMA II

Study Design

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

Study Groups

Robot Asissted Gait Training

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.

Group Type: EXPERIMENTAL

ATLAS 2030

Intervention Type: DEVICE

The participant will attend the laboratory every week, two days a week. The therapy will consist of the use of the exoskeleton for rehabilitative purposes. At the end of each three-month period, each patient's data will be monitored.

Interventions

ATLAS 2030

The participant will attend the laboratory every week, two days a week. The therapy will consist of the use of the exoskeleton for rehabilitative purposes. At the end of each three-month period, each patient's data will be monitored.

Intervention Type: DEVICE

Other Intervention Names

Robot Asissted Gait Training

Eligibility Criteria

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

• 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

National Research Council, Spain

OTHER_GOV

Sponsor Role: collaborator

MarsiBionics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandra Espinosa García, Medicine

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz

Locations

MarsiCare

Arganda, Madrid, Spain

Countries

Spain

Other Identifiers

ATLAS2030CLI-I

Identifier Type: -

Identifier Source: org_study_id