study details
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:
• Eligible Ages: 3 - 11
• Eligible Sexes: all
Inclusion Criteria:
Children with neuromuscular disease or cerebral palsy who have gait disturbance or no gait.
Children between 3 and 11 years of age.
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