Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing

Study Overview
=================
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 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.

Official Title
-----------------
Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing

Conditions
-----------------
Acquired Brain Injury

Intervention / Treatment
-----------------
* Device: pseudoelastic orthosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: Fixed limitations of the joint. Joint pain. Skin allergies. Behavioral and psychiatric disorders (eg, emotional problems, anxiety, panic attacks).

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Upper limb rehabilitation with pseudoelastic orthosis | Device: pseudoelastic orthosis<br>* 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.<br>|
| No Intervention: Control<br>Upper limb rehabilitation without pseudoelastic orthosis | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint Stiffness of affected upper limb joint | Quantitative measure performed by means of an isokinetic machine (Unit of measure: Nm/°). Changes in joint stiffness following the use of new customized devices during a rehabilitation treatment period. Lower stiffness is better. | After 4 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth Scale | Clinical scale for spasticity (5 levels), higher is worse. | After 4 weeks of treatment | 
| Melbourne Upper Limb Assessment 2 | Clinical scale for evaluating quality of upper limb movement (16 items, each assessed from 0 to 4 points). Result reported in %. Higher is better. | After 4 weeks of treatment | 
| Quality of Upper Extremity Skills Test | Clinical scale evaluating the quality of upper extremity function (33 items, 4 domains). Minimum score 0, maximum score 100. Higher is better. | After 4 weeks of treatment | 
| Active range of motion | Measured with goniometer in degrees. | After 4 weeks of treatment | 
| Passive range of motion | Measured with goniometer in degrees. | After 4 weeks of treatment | 
| Range of motion of target joint during a pointing-forward task | Measured in degrees. A kinematic analysis will be performed during a pointing-forward task using an optoelectronic system. | After 4 weeks of treatment |