Clinical trial NCT04813601: Rehabilitative Effect of the Use of a Gait Exoskeleton in Patients With Neuromuscular Disease or Cerebral Palsy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Diseases
Cerebral Palsy
SMA II
Keywords: Gait Exoskeleton
Robotics
Children
ATLAS 2030
Neuromuscular disease
Cerebral Palsy
Rehabilitation
Lead sponsor: MarsiBionics
Sponsor class: INDUSTRY
Collaborators: name: Hospital Universitario La Paz
name: National Research Council, Spain
First posted: 2021-03-24
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Muscular balance
timeFrame: 1 month
measure: Expanded Hammersmith Functional Motor Scale
timeFrame: 3 months
measure: Gross Motor Function Measure 88 (GMFM-88)
timeFrame: 3 months
measure: Respiratory rate
timeFrame: 1 day
measure: Heart rate
timeFrame: 1 day
measure: Oxigen Saturation
timeFrame: 1 day
measure: Blood preasure
timeFrame: 1 day
measure: Respiratory functional parameters
timeFrame: 3 months
measure: Quality of life assessment
timeFrame: 3 months
measure: Joint range of motion
timeFrame: 1 month
measure: Revised Upper Limb Module (RULM)
timeFrame: 3 months
measure: Quality Upper Extremity Skill test (QUEST)
timeFrame: 3 months
measure: The Functional Independence Measure for Children (WeeFim)
timeFrame: 3 months
measure: Egen Klassifikation
timeFrame: 3 months
measure: Skin integrity
timeFrame: 1 day
measure: Fatigue
timeFrame: 1 day
measure: Pain assessment
timeFrame: 1 day
measure: Peak Flow cough
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Arganda Del Rey
country: Spain
facility: MarsiCare
state: Madrid
Study officials:
affiliation: Hospital Universitario La Paz
name: Sandra Espinosa García, Medicine
role: PRINCIPAL_INVESTIGATOR
References: