Status:
UNKNOWN
Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing
Lead Sponsor:
IRCCS Eugenio Medea
Collaborating Sponsors:
CNR - ICMATE UOS di Lecco
Conditions:
Acquired Brain Injury
Eligibility:
All Genders
6-20 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- Quadriplegia or acquired hemiplegia.
- Age 6-20 years.
- Dystonic, dyskinetic, spastic.
- Chronic phase patients (\> 1 year post event).
- Spastic syndrome with Ashworth Score (AS) for the limb of interest\> 1.
- Collaborative.
Exclusion
- Fixed limitations of the joint.
- Joint pain.
- Skin allergies.
- Behavioral and psychiatric disorders (eg, emotional problems, anxiety, panic attacks).
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04328857
Start Date
October 1 2020
End Date
May 31 2023
Last Update
February 8 2023
Active Locations (1)
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1
IRCCS Eugenio Medea
Bosisio Parini, LC, Italy, 23842