Acquired Brain Injury
Conditions
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.
Interventions
DEVICEAnkle 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.
Sponsors
The National Research Council, Italy
Regione Lombardia
IRCCS Eugenio Medea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Passive range of motion of ankle dorsi-plantarflexion | Change from baseline after 4 weeks of treatment | Measured with goniometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ankle joint stiffness | Change from baseline after 4 weeks of treatment | Device: isokinetic machine |
| 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. |
| Cerebral activation | Change from baseline after 4 weeks of treatment | functional Magnetic Resonance blood oxygenation level dependent imaging |
| Time-Domain Near-Infrared Spectroscopy | Change from baseline after 4 weeks of treatment | Blood oxygen saturation in muscles |
Countries
Italy
Outcome results
None listed