Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing

NCT04328857 | Unknown

• 1 other identifier: 686
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Modified Ashworth Scale

  After 4 weeks of treatment

• Melbourne Upper Limb Assessment 2

  After 4 weeks of treatment

• Quality of Upper Extremity Skills Test

  After 4 weeks of treatment

• Active range of motion

  After 4 weeks of treatment

• Passive range of motion

  After 4 weeks of treatment

Study Arms (2)

Treatment

EXPERIMENTAL

Upper limb rehabilitation with pseudoelastic orthosis

Device: pseudoelastic orthosis

Control

NO INTERVENTION

Upper limb rehabilitation without pseudoelastic orthosis

Interventions

pseudoelastic orthosis DEVICE

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.

Treatment

Eligibility Criteria

• Age: 6 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• CNR - ICMATE UOS di Lecco: collaborator

Study Sites (1)

IRCCS Eugenio Medea

Bosisio Parini, LC, 23842, Italy

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Elena Beretta

CONTACT

031877851; elena.beretta@lanostrafamiglia.it

FAbio A Storm

CONTACT

fabio.storm@lanostrafamiglia.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 31, 2020
• Study Start: October 1, 2020
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)