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| Name | Class |
|---|---|
| CNR - ICMATE UOS di Lecco | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Upper limb rehabilitation with pseudoelastic orthosis |
|
| Control | No Intervention | Upper limb rehabilitation without pseudoelastic orthosis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pseudoelastic orthosis | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena Beretta | Contact | 031877851 | elena.beretta@lanostrafamiglia.it | |
| FAbio A Storm | Contact | fabio.storm@lanostrafamiglia.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Eugenio Medea | Recruiting | Bosisio Parini | LC | 23842 | Italy |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| 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 |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |