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Experimentation of an Ankle Mobilization Device for the Rehabilitation of Patients With Acquired Brain Injuries.

NCT03879070 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-03-02

No results posted yet for this study

Summary

The proposed clinical investigation plan is a randomized controlled pivotal study with 2 parallel groups, has a total duration of two years. For the study, 30 pediatric patients suffering from acquired brain injury will be recruited at the Scientific institute Eugenio Medea.

The primary aim of this study is to assess the clinical benefit of using an ankle mobilization device for the rehabilitation of pediatric patients with acquired brain injuries, on its clinical performance and its risks, and on its safety.

The efficacy of the treatment will be evaluated in terms of ankle range of motion (primary outcome). The effects of the treatment on musculoskeletal plasticity will be studied using an isokinetic machine and functional magnetic resonance imaging will provide information on variations of reactivity in the motor cortical network. Ease of use, safety and usability of the device will also be evaluated.

Conditions

  • Acquired Brain Injury

Interventions

DEVICE

Ankle active and passive mobilization using an Ankle mobilization device

The treatment consists in 20 rehabilitation sessions, 5 times/week for 4 weeks. The device is capable of generating ankle dorsi/plantarflexion movements using two activation modes: passive and assistive. In the passive mode the device generates a movement pattern which the patient follows passively without exerting any force on the device. During the assistive mode, the device follows the active movement of the patient. During the intervention, these two modes will be alternated.

Sponsors & Collaborators

  • The National Research Council, Italy

    collaborator OTHER_GOV

  • Regione Lombardia

    collaborator OTHER

  • IRCCS Eugenio Medea

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2021-01-01
Completion
2021-02-01

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 NCT03879070 on ClinicalTrials.gov