Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing

• Sponsor: IRCCS Eugenio Medea (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04328857
• Collaborator: CNR - ICMATE UOS di Lecco (Other)
• Enrollment: 34
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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
• Actual Study Start Date: Oct 1, 2020
• Anticipated Primary Completion Date: May 31, 2022
• Anticipated Study Completion Date: May 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Modified Ashworth Scale [After 4 weeks of treatment]

   Clinical scale for spasticity (5 levels), higher is worse.

2. 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.

3. 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.

4. Active range of motion [After 4 weeks of treatment]

   Measured with goniometer in degrees.

5. Passive range of motion [After 4 weeks of treatment]

   Measured with goniometer in degrees.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 20 Years
• 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS Eugenio Medea	Bosisio Parini	LC	Italy	23842

Sponsors and Collaborators

• IRCCS Eugenio Medea
• CNR - ICMATE UOS di Lecco

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: IRCCS Eugenio Medea
• ClinicalTrials.gov Identifier: NCT04328857
• Other Study ID Numbers: 686
• First Posted: Mar 31, 2020
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Brain Injuries

Study Results

No Results Posted as of Mar 31, 2022