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

March 1, 2023 updated by: IRCCS Eugenio Medea

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lecco
      • Bosisio Parini, Lecco, Italy, 23842
        • IRCCS E. Medea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Tetraplegic and hemiplegic acquired brain injury patients, within first month of injury.
  • Spastic syndrome (ankle joint Modified Ashworth Scale > 1).

Exclusion Criteria:

  • Pace maker or other contraindication to Magnetic Resonance Imaging scans.
  • Other serious comorbidity.
  • Behaviour and psychiatric disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Intervention group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Passive range of motion of ankle dorsi-plantarflexion
Time Frame: Change from baseline after 4 weeks of treatment
Measured with goniometer
Change from baseline after 4 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ankle joint stiffness
Time Frame: Change from baseline after 4 weeks of treatment
Device: isokinetic machine
Change from baseline after 4 weeks of treatment
Medical Research Council (MRC) Scale for Muscle Strength
Time Frame: Change from baseline after 4 weeks of treatment
Scale for measuring Muscle Strength, range 0-5, higher is better.
Change from baseline after 4 weeks of treatment
Cerebral activation
Time Frame: Change from baseline after 4 weeks of treatment
functional Magnetic Resonance blood oxygenation level dependent imaging
Change from baseline after 4 weeks of treatment
Time-Domain Near-Infrared Spectroscopy
Time Frame: Change from baseline after 4 weeks of treatment
Blood oxygen saturation in muscles
Change from baseline after 4 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Eugenio Medea

Collaborators

Regione Lombardia
National Research Council of Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

February 1, 2021

Study Registration Dates

First Submitted

March 13, 2019

First Submitted That Met QC Criteria

March 15, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

March 2, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIP599

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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