Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing

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.

Study Overview

• Status: Recruiting
• Conditions: Acquired Brain Injury
• Intervention / Treatment: Device: pseudoelastic orthosis

• Study Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elena Beretta; Phone Number: 031877851; Email: elena.beretta@lanostrafamiglia.it
• Study Contact Backup: Name: FAbio A Storm; Email: fabio.storm@lanostrafamiglia.it

Study Locations

• Italy
  • LC
    • Bosisio Parini, LC, Italy, 23842
      • Recruiting
      • IRCCS Eugenio Medea
      • Contact: Elena Beretta, MD; Phone Number: +39031877111; Email: elena.beretta@lanostrafamiglia.it
      • Sub-Investigator: Fabio A Storm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 20 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea
• Collaborators: CNR - ICMATE UOS di Lecco

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ANTICIPATED): May 31, 2023
• Study Completion (ANTICIPATED): May 31, 2023

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (ACTUAL): March 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries
• Other Study ID Numbers: 686

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No