Brain Injuries, Brain Injuries, Traumatic, Brain Injuries, Vascular
Conditions
Keywords
acquired brain injury, traumatic, virtual reality, cognitive function, rehabilitation, disability, lower limb, personalized medicine
Brief summary
Severe Acquired Brain Injury (sABI) is defined as an encephalic impairment that occurs after birth and is not related to a congenital or degenerative disease. This impairment may be temporary, or permanent, and cause partial or functional disability or psychosocial distress. In Italy there are at least 10-15 new cases of sABI per year per 100,000 inhabitants; the estimated prevalence is about 150,000 cases per year. Often, people with sABI present focal neurological deficits, including alterations in strength, sensitivity, coordination and gait. Most of the rehabilitation protocols for people with sABI are derived from post-stroke studies, caused by lack of evidence on specific rehabilitation of people with sABI. Rehabilitation of people with sABI should begin as soon as possible, to prevent the onset of retractions and decubitus, and to regain joint mobility, strength, and coordination. OMEGO® (Tyromotion) is a newly developed device used in lower extremity rehabilitation, that provides visual and auditory feedback. Specifically, OMEGO® contains several games developed to enhance and promote learning behaviors, that simulate activities of daily living. The use of devices such as cycle ergometers is recommended in the rehabilitation of people with sABI; however, there are no studies demonstrating the effect of cycle ergometer training in association with visual feedback. The purpose of this study is to evaluate, both in people without apparent pathology (hereafter identified as healthy) and in people with sABI, whether visual feedback during OMEGO® exercise modifies brain connectivity, emotional drive, and lower limb performance during a lower limb-specific motor rehabilitation task.
Interventions
DEVICEOMEGO®
Lower limb rehabilitation with and without visual feedback
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis os severe Acquired Brain Injury (sABI) * Trunk Control Test score greater or equal to 48 * Motricity Index Lower Limb score greater or equal to 18 * Clinical stability * Patient/Caregiver ability to understand ans sing the informed consent
Exclusion criteria
* Disorder of consciousness (mininally concious state or vegetative state) * severe visual impairment (central or peripheral, prior or acquired after the scute event) * presence of severe cognitive impairment * presence of global aphasia or presence of severe apraxia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Symmetry after the performance of the motor task | Change from baseline at T4 [after 18 minutes] | The symmetry between lower limbs will be evaluated, comparing the percentage of movement between limbs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brain connectivity | Baseline [T0]; after 5 minutes [training1, T1], after 8 minutes [rest, T2]; after 13 minutes [training2,T3] and after 18 minutes [rest, T4] | Assessment of brain connectivity will be performed by evaluating the EEG |
| Electrodermal activity | Baseline [T0]; after 5 minutes [training1, T1], after 8 minutes [rest, T2]; after 13 minutes [training2,T3] and after 18 minutes [rest, T4] | Electrodermal activity assessment will be performed using the E4 wearable medical device (Empatica) |
| Heart Rate Variability | Baseline [T0]; after 5 minutes [training1, T1], after 8 minutes [rest, T2]; after 13 minutes [training2,T3] and after 18 minutes [rest, T4] | Heart Rate Variability assessment will be performed using the E4 wearable medical device (Empatica) |
| Change of Proprioception | Change from baseline at T4 [after 18 minutes] | The proprioception of lower limbs will be evaluated by asking the patient to reach with the lower limb an indicated position |
Countries
Italy
Outcome results
None listed