Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing

Acquired Brain Injury Clinical Trial

Official title:

Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04328857
• Other study ID #: 686
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: May 31, 2023

Study information

• Verified date: February 2023
• Source: IRCCS Eugenio Medea
• Contact: Elena Beretta
• Phone: 031877851
• Email: elena.beretta[@]lanostrafamiglia.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 20 Years

Eligibility

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).

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Eugenio Medea	Bosisio Parini	LC

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea	CNR - ICMATE UOS di Lecco

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Modified Ashworth Scale	Clinical scale for spasticity (5 levels), higher is worse.	After 4 weeks of treatment
Secondary	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
Secondary	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
Secondary	Active range of motion	Measured with goniometer in degrees.	After 4 weeks of treatment
Secondary	Passive range of motion	Measured with goniometer in degrees.	After 4 weeks of treatment
Secondary	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