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

Estudio Piloto de Una Serie de Casos Para Evaluar el Efecto Rehabilitador Del Uso de un Exoesqueleto de Marcha en Pacientes Con patología Neuromuscular o parálisis Cerebral

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Neuromuscular Diseases; SMA II
• Intervention / Treatment: Device: ATLAS 2030

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Arganda Del Rey, Madrid, Spain, 28500
      • MarsiCare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: Robot Asissted Gait Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscular balance	Strength measured in Newtons with a Hand-Held Dinamometer for elbow flexion, neck lateralization, ankle plantarflexion and dorsiflexion, knee flexion and extension.	1 month
Expanded Hammersmith Functional Motor Scale	Motor functionality measured for children with Spinal Muscular Atrophy	3 months
Gross Motor Function Measure 88 (GMFM-88)	Motor functionality measured for children with Cerebral Palsy.	3 months
Respiratory rate	Respiratory rate measured manually in breaths per minute using chronometer	1 day
Heart rate	Measured in beats per minute using vital sign monitor	1 day
Oxigen Saturation	Measured in %O2 using vital sign monitor	1 day
Blood preasure	measured in mmHg with a sphyngomanometer	1 day
Respiratory functional parameters	Measured by Spirometer (volumes measured in litres and pressures in mmHg)	3 months
Quality of life assessment	Quality of life iof the children measured using the KINDL questionnaire.	3 months
Joint range of motion	Range of motion in degrees of hip, knee and ankle movements using a manual goniometer.	1 month
Revised Upper Limb Module (RULM)	Upper limb quality of movement using RULM scale for Spinal Muscular Atrophy children	3 months
Quality Upper Extremity Skill test (QUEST)	Upper limb quality of movement using QUEST scale for cerebral palsy children	3 months
The Functional Independence Measure for Children (WeeFim)	WeeFim scale for CP children.	3 months
Egen Klassifikation	Functional ability measured using EK2 scale for SMA	3 months
Skin integrity	Skin alterations assessing their localization, size (centimeters), redness and temperature increase.	1 day
Fatigue	Patient fatigue measured by Borg fatigue scale for children ages	1 day
Pain assessment	Patient pain measured by EVA faces scale for children ages	1 day
Peak Flow cough	Measured in litres per minute using a Peak flowmeter	1 week

Collaborators and Investigators

• Sponsor: MarsiBionics
• Collaborators: National Research Council, Spain; Hospital Universitario La Paz
• Investigators: Principal Investigator: Sandra Espinosa García, Medicine, Hospital Universitario La Paz

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2020
• Primary Completion (Actual): March 9, 2021
• Study Completion (Actual): September 24, 2023

Study Registration Dates

• First Submitted: March 15, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Cerebral Palsy; Children; Robotics; Neuromuscular disease; Gait Exoskeleton; ATLAS 2030
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy; Neuromuscular Diseases
• Other Study ID Numbers: ATLAS2030CLI-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: Researchers who will asked for this data and with previous approval provided by reserach sponsor
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No