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Experimentation of Sensorized Pseudoelastic Orthoses Produced by Additive Manufacturing

NCT04328857 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-02-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • CNR - ICMATE UOS di Lecco

    collaborator UNKNOWN

  • IRCCS Eugenio Medea

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2023-05-31
Completion
2023-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04328857 on ClinicalTrials.gov