Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Cerebral Palsy
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Sequential AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 6 years and 11 years
Gender
Both males and females

Description

The main objective therefore provides for an improvement in the involvement of these children in sports activities (both at school and during leisure time) through the development of new generation orthoses. Secondary objective: the second objective involves the verification of the orthosis previous...

The main objective therefore provides for an improvement in the involvement of these children in sports activities (both at school and during leisure time) through the development of new generation orthoses. Secondary objective: the second objective involves the verification of the orthosis previously designed and built, ie the device must comply with the project specifications and allow the patient to perform sports activities. Correct functioning will be tested by functional evaluation of the model developed through biomechanical analysis of movement performed indoors (in the laboratory) and outdoors. Notes on the calculation of the sample size: the project foresees the involvement at the moment of 20 children with hemiplegia under treatment at MEDEA to whom an overall improvement of the living conditions is to be guaranteed. Steps: 1-Technology design - "to play together" 2 - Analysis and identification of the guidelines for the prescription of use; 3 - Evaluation of the motor biomechanical situation of subjects wearing orthoses: indoor and outdoor to evaluate the limits of the orthosis used; 4 - identification of indicators for the evaluation of motor performance; 5 - Identification of the technical specifications (functional and clinical, mechanical, structural, geometric, materials, design) of the new generation orthosis-sensor system. 6- Definition of inclusion criteria, recruitment of 20 subjects starting from Medea and contacts with schools and families to which they belong. 7- Validation- "to verify it really runs" WP5.1 - Functional evaluation of the model developed through biomechanical analysis of movement carried out in the laboratory. The I.R.C.C.S E. Medea will appropriately select 20 children with hemiplegia and wearers of orthoses. A biomechanical assessment will be performed through gait analysis to identify the limits of the orthosis used. 8- Two conditions will be evaluated: walking tests without orthoses; walking tests with orthoses usually used. From the comparative analysis of the collected data, the criticalities of the device will be defined in order to identify the project specifications of the new generation orthosis. 9-Following the design and construction of the new AFO, a biomechanical evaluation will be performed again by means of gait analysis to validate its correct functioning. 10- Further validation will be performed using virtual reality environments (GRAIL Gait Real time Analysis Interactive Lab). After a rehabilitation process, once a certain degree of confidence has been reached in the use of the new orthosis, the device will be tested using outdoor wearable sensors. By doing so, it will be possible to identify indicators for the evaluation of sports performance.

Tracking Information

NCT #
NCT04794114
Collaborators
Not Provided
Investigators
Not Provided