Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing

Not Applicable

Recruiting

• Conditions: Acquired Brain Injury

• Registration Number: NCT04328857
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-27
• Study First Submitted QC: 2020-03-30
• Study First Posted: 2020-03-31
• Study Start: 2020-10-01
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-02-08
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Joint Stiffness of affected upper limb joint	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

Name	Time	Method
Melbourne Upper Limb Assessment 2	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.
Range of motion of target joint during a pointing-forward task	After 4 weeks of treatment	Measured in degrees. A kinematic analysis will be performed during a pointing-forward task using an optoelectronic system.
Active range of motion	After 4 weeks of treatment	Measured with goniometer in degrees.
Passive range of motion	After 4 weeks of treatment	Measured with goniometer in degrees.
Quality of Upper Extremity Skills Test	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.
Modified Ashworth Scale	After 4 weeks of treatment	Clinical scale for spasticity (5 levels), higher is worse.

Trial Locations

Locations (1)

IRCCS Eugenio Medea; 🇮🇹 Bosisio Parini, LC, Italy