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Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04328857
Recruitment Status : Not yet recruiting
First Posted : March 31, 2020
Last Update Posted : July 31, 2020
Information provided by (Responsible Party):
IRCCS Eugenio Medea

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.

Condition or disease Intervention/treatment Phase
Acquired Brain Injury Device: pseudoelastic orthosis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Modified Ashworth Scale [ Time Frame: After 4 weeks of treatment ]
    Clinical scale for spasticity (5 levels), higher is worse.

  2. 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.

  3. 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.

  4. Active range of motion [ Time Frame: After 4 weeks of treatment ]
    Measured with goniometer in degrees.

  5. Passive range of motion [ Time Frame: After 4 weeks of treatment ]
    Measured with goniometer in degrees.

  6. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Quadriplegia or acquired hemiplegia.
  2. Age 6-20 years.
  3. Dystonic, dyskinetic, spastic.
  4. Chronic phase patients (> 1 year post event).
  5. Spastic syndrome with Ashworth Score (AS) for the limb of interest> 1.
  6. Collaborative.

Exclusion Criteria:

  1. Fixed limitations of the joint.
  2. Joint pain.
  3. Skin allergies.
  4. Behavioral and psychiatric disorders (eg, emotional problems, anxiety, panic attacks).

Information from the National Library of Medicine

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 identifier (NCT number): NCT04328857

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Contact: Elena Beretta 031877851
Contact: FAbio A Storm

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IRCCS Eugenio Medea
Bosisio Parini, LC, Italy, 23842
Contact: Elena Beretta, MD    +39031877111   
Sub-Investigator: Fabio A Storm         
Sponsors and Collaborators
IRCCS Eugenio Medea
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Responsible Party: IRCCS Eugenio Medea Identifier: NCT04328857    
Other Study ID Numbers: 686
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries