Experimentation of an Ankle Mobilization Device for the Rehabilitation of Patients With Acquired Brain Injuries.
- Conditions
- Acquired Brain Injury
- Interventions
- Device: Ankle active and passive mobilization using an Ankle mobilization device
- Registration Number
- NCT03879070
- Lead Sponsor
- IRCCS Eugenio Medea
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Tetraplegic and hemiplegic acquired brain injury patients, within first month of injury.
- Spastic syndrome (ankle joint Modified Ashworth Scale > 1).
- Pace maker or other contraindication to Magnetic Resonance Imaging scans.
- Other serious comorbidity.
- Behaviour and psychiatric disorders.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Ankle active and passive mobilization using an Ankle mobilization device -
- Primary Outcome Measures
Name Time Method Passive range of motion of ankle dorsi-plantarflexion Change from baseline after 4 weeks of treatment Measured with goniometer
- Secondary Outcome Measures
Name Time Method Medical Research Council (MRC) Scale for Muscle Strength Change from baseline after 4 weeks of treatment Scale for measuring Muscle Strength, range 0-5, higher is better.
Time-Domain Near-Infrared Spectroscopy Change from baseline after 4 weeks of treatment Blood oxygen saturation in muscles
Ankle joint stiffness Change from baseline after 4 weeks of treatment Device: isokinetic machine
Cerebral activation Change from baseline after 4 weeks of treatment functional Magnetic Resonance blood oxygenation level dependent imaging
Trial Locations
- Locations (1)
IRCCS E. Medea
🇮🇹Bosisio Parini, Lecco, Italy