Experimentation of an Ankle Mobilization Device for the Rehabilitation of Patients With Acquired Brain Injuries.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Acquired Brain Injury
- Sponsor
- IRCCS Eugenio Medea
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Passive range of motion of ankle dorsi-plantarflexion
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Passive range of motion of ankle dorsi-plantarflexion
Time Frame: Change from baseline after 4 weeks of treatment
Measured with goniometer
Secondary Outcomes
- Ankle joint stiffness(Change from baseline after 4 weeks of treatment)
- Cerebral activation(Change from baseline after 4 weeks of treatment)
- Medical Research Council (MRC) Scale for Muscle Strength(Change from baseline after 4 weeks of treatment)
- Time-Domain Near-Infrared Spectroscopy(Change from baseline after 4 weeks of treatment)