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

Primary Purpose

Acquired Brain Injury

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Ankle active and passive mobilization using an Ankle mobilization device
Sponsored by
IRCCS Eugenio Medea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Brain Injury

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • IRCCS E. Medea

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Passive range of motion of ankle dorsi-plantarflexion
Measured with goniometer

Secondary Outcome Measures

Ankle joint stiffness
Device: isokinetic machine
Medical Research Council (MRC) Scale for Muscle Strength
Scale for measuring Muscle Strength, range 0-5, higher is better.
Cerebral activation
functional Magnetic Resonance blood oxygenation level dependent imaging
Time-Domain Near-Infrared Spectroscopy
Blood oxygen saturation in muscles

Full Information

First Posted
March 13, 2019
Last Updated
March 1, 2023
Sponsor
IRCCS Eugenio Medea
Collaborators
National Research Council of Italy, Regione Lombardia
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1. Study Identification

Unique Protocol Identification Number
NCT03879070
Brief Title
Experimentation of an Ankle Mobilization Device for the Rehabilitation of Patients With Acquired Brain Injuries.
Official Title
Experimentation of an Ankle Mobilization Device for the Rehabilitation of Patients With Acquired Brain Injuries.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Eugenio Medea
Collaborators
National Research Council of Italy, Regione Lombardia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Ankle active and passive mobilization using an Ankle mobilization device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Passive range of motion of ankle dorsi-plantarflexion
Description
Measured with goniometer
Time Frame
Change from baseline after 4 weeks of treatment
Secondary Outcome Measure Information:
Title
Ankle joint stiffness
Description
Device: isokinetic machine
Time Frame
Change from baseline after 4 weeks of treatment
Title
Medical Research Council (MRC) Scale for Muscle Strength
Description
Scale for measuring Muscle Strength, range 0-5, higher is better.
Time Frame
Change from baseline after 4 weeks of treatment
Title
Cerebral activation
Description
functional Magnetic Resonance blood oxygenation level dependent imaging
Time Frame
Change from baseline after 4 weeks of treatment
Title
Time-Domain Near-Infrared Spectroscopy
Description
Blood oxygen saturation in muscles
Time Frame
Change from baseline after 4 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
IRCCS E. Medea
City
Bosisio Parini
State/Province
Lecco
ZIP/Postal Code
23842
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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