Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing
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|ClinicalTrials.gov Identifier: NCT04328857|
Recruitment Status : Not yet recruiting
First Posted : March 31, 2020
Last Update Posted : July 31, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Acquired Brain Injury||Device: pseudoelastic orthosis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing|
|Estimated Study Start Date :||October 1, 2020|
|Estimated Primary Completion Date :||January 31, 2021|
|Estimated Study Completion Date :||January 31, 2021|
Upper limb rehabilitation with pseudoelastic orthosis
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.
No Intervention: Control
Upper limb rehabilitation without pseudoelastic orthosis
- Joint Stiffness of affected upper limb joint [ Time Frame: After 4 weeks of treatment ]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.
- Modified Ashworth Scale [ Time Frame: After 4 weeks of treatment ]Clinical scale for spasticity (5 levels), higher is worse.
- Melbourne Upper Limb Assessment 2 [ Time Frame: After 4 weeks of treatment ]Clinical scale for evaluating quality of upper limb movement (16 items, each assessed from 0 to 4 points). Result reported in %. Higher is better.
- Quality of Upper Extremity Skills Test [ Time Frame: After 4 weeks of treatment ]Clinical scale evaluating the quality of upper extremity function (33 items, 4 domains). Minimum score 0, maximum score 100. Higher is better.
- Active range of motion [ Time Frame: After 4 weeks of treatment ]Measured with goniometer in degrees.
- Passive range of motion [ Time Frame: After 4 weeks of treatment ]Measured with goniometer in degrees.
- Range of motion of target joint during a pointing-forward task [ Time Frame: After 4 weeks of treatment ]Measured in degrees. A kinematic analysis will be performed during a pointing-forward task using an optoelectronic system.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04328857
|Contact: Elena Berettaemail@example.com|
|Contact: FAbio A Stormfirstname.lastname@example.org|
|IRCCS Eugenio Medea|
|Bosisio Parini, LC, Italy, 23842|
|Contact: Elena Beretta, MD +39031877111 email@example.com|
|Sub-Investigator: Fabio A Storm|