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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acquired Brain Injury

Intervention / Treatment
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* Device: Ankle active and passive mobilization using an Ankle mobilization device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br> | Device: Ankle active and passive mobilization using an Ankle mobilization device<br>* 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.<br>|
| No Intervention: Control group<br> | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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