Efecto rehabilitador del uso de un exoesqueleto de marcha en pacientes con enfermedad neuromuscular o parálisis cerebral

ID de estudio #: NCT04813601

condición: Neuromuscular Diseases, Cerebral Palsy, SMA II

Estado: Reclutamiento

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.

intervención: ATLAS 2030

Resultados: https://clinicaltrials.gov/ct2/show/results/NCT04813601

última actualización: Febrero

fecha de inicio: Marzo 9, 2020

finalización estimada: Diciembre 2023

última actualización: Marzo 24, 2021

fase de desarrollo: No aplicable

tamaño / inscripción: 10

descripción del estudio: Los objetivos del estudio son:

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.
Objetivo 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.

resultados primarios:

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

criterios de inclusión:

Criterio de exclusión: Criterios:

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

patrocinador: MarsiBionics

Contactos: Marie Destarac, 914 90 00 90, marie.destarac@marsibionics.com

investigadores Mercedes Martinez, Medicine,Marsi Bionics

ubicaciones del centro de prueba: España

• Efecto rehabilitador del uso de un exoesqueleto de marcha en pacientes con enfermedad neuromuscular o parálisis cerebral
  Jaime Ramos, 918 71 19 00, jaime.ramos@csic.es