Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Cerebral Palsy
  • Neuromuscular Diseases
  • SMA II
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 3 years and 11 years
Gender
Both males and females

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 progressi...

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.

Tracking Information

NCT #
NCT04813601
Collaborators
  • Hospital Universitario La Paz
  • National Research Council, Spain
Investigators
Principal Investigator: Mercedes Martinez, Medicine Marsi Bionics