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Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing

Acquired Brain Injury Clinical Trial

Official title:
Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing

Clinical Trial Summary

The proposed clinical investigation plan is a pivotal controlled study with two parallel groups, has a total duration of 12 months and involves the recruitment of 34 pediatric patients suffering from acquired brain injury. The primary objective of the clinical study is to evaluate the improvement of joint stiffness through the use of sensorized pseudoelastic orthoses for the rehabilitation of pediatric patients with acquired brain injury. The effectiveness of the treatment in terms of joint stiffness (primary outcome) will be assessed and the effect of the treatment will be quantified with clinical evaluation scales and instrumental measurements by means of an optoelectronic system and isokinetic machine. The tolerability and acceptability of the device will also be checked.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04328857
Study type Interventional
Source IRCCS Eugenio Medea
Contact Elena Beretta
Phone 031877851
Email elena.beretta@lanostrafamiglia.it
Status Recruiting
Phase N/A
Start date October 1, 2020
Completion date May 31, 2023
View Details
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