NCT04328857

Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: IRCCS Eugenio Medea · Academic / Other
• Sex: All
• Age: 6 Years – 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acquired Brain Injury

Interventions

Type	Name	Description
DEVICE	pseudoelastic orthosis	The subject will be given specific physiotherapy including activities oriented to multimodal exploration and refinement of gross and fine motor skills, customized according to the functional status of the individual patient.

Timeline

• Start date: 2020-10-01
• Primary completion: 2023-05-31
• Completion: 2023-05-31
• First posted: 2020-03-31
• Last updated: 2023-02-08

Locations

1 site across 1 country: Italy