Cerebral Palsy, Neuromuscular Diseases, SMA II
Conditions
Keywords
Gait Exoskeleton, Robotics, Children, ATLAS 2030, Neuromuscular disease, Cerebral Palsy, Rehabilitation
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.
Interventions
DEVICEATLAS 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.
Sponsors
Hospital Universitario La Paz
National Research Council, Spain
MarsiBionics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscular balance | 1 month | Strength measured in Newtons with a Hand-Held Dinamometer for elbow flexion, neck lateralization, ankle plantarflexion and dorsiflexion, knee flexion and extension. |
| Expanded Hammersmith Functional Motor Scale | 3 months | Motor functionality measured for children with Spinal Muscular Atrophy |
| Gross Motor Function Measure 88 (GMFM-88) | 3 months | Motor functionality measured for children with Cerebral Palsy. |
| Respiratory rate | 1 day | Respiratory rate measured manually in breaths per minute using chronometer |
| Heart rate | 1 day | Measured in beats per minute using vital sign monitor |
| Oxigen Saturation | 1 day | Measured in %O2 using vital sign monitor |
| Blood preasure | 1 day | measured in mmHg with a sphyngomanometer |
| Respiratory functional parameters | 3 months | Measured by Spirometer (volumes measured in litres and pressures in mmHg) |
| Quality of life assessment | 3 months | Quality of life iof the children measured using the KINDL questionnaire. |
| Joint range of motion | 1 month | Range of motion in degrees of hip, knee and ankle movements using a manual goniometer. |
| Revised Upper Limb Module (RULM) | 3 months | Upper limb quality of movement using RULM scale for Spinal Muscular Atrophy children |
| Quality Upper Extremity Skill test (QUEST) | 3 months | Upper limb quality of movement using QUEST scale for cerebral palsy children |
| The Functional Independence Measure for Children (WeeFim) | 3 months | WeeFim scale for CP children. |
| Egen Klassifikation | 3 months | Functional ability measured using EK2 scale for SMA |
| Skin integrity | 1 day | Skin alterations assessing their localization, size (centimeters), redness and temperature increase. |
| Fatigue | 1 day | Patient fatigue measured by Borg fatigue scale for children ages |
| Pain assessment | 1 day | Patient pain measured by EVA faces scale for children ages |
| Peak Flow cough | 1 week | Measured in litres per minute using a Peak flowmeter |
Countries
Spain
Outcome results
None listed