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

study id #: NCT04813601

condition: Neuromuscular Diseases, Cerebral Palsy, SMA II

status: Recruiting

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.

intervention: ATLAS 2030

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

last updated: February 04, 2022

start date: March 9, 2020

estimated completion: December 2023

last updated: March 24, 2021

phase of development: Not Applicable

size / enrollment: 10

study 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.

primary outcomes:

• 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
  

inclusion criteria:

exclusion criteria: 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

sponsor: MarsiBionics

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

investigators: Mercedes Martinez, Medicine,Marsi Bionics

trial center locations: Spain

• Rehabilitative Effect of the Use of a Gait Exoskeleton in Patients With Neuromuscular Disease or Cerebral Palsy
  Jaime Ramos, 918 71 19 00, jaime.ramos@csic.es