Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing

IRCCS Eugenio Medea

Status: Enrolling

Conditions: Acquired Brain Injury

Treatments: Device: pseudoelastic orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT04328857

686

Details and patient eligibility

About

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.

Enrollment: 34 estimated patients

Sex: All

Ages: 6 to 20 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Treatment

Experimental group

Description:

Upper limb rehabilitation with pseudoelastic orthosis

Treatment:

Device: pseudoelastic orthosis

Control

No Intervention group

Description:

Upper limb rehabilitation without pseudoelastic orthosis