Visual Feedback in Lower Limb Rehabilitation

Study Overview
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Brief Summary
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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.

Official Title
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Visual Feedback in Lower Limb Rehabilitation: the Alpha and the OMEGO®

Conditions
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Brain Injuries, Brain Injuries, Traumatic, Brain Injuries, Vascular

Intervention / Treatment
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* Device: OMEGO®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (no visual feedback-visual feedback)<br>Participants in group A (6 patients with sABI and 6 healthy controls), will perform a single rehabilitation session with OMEGO®. In total, they will perform 18 minutes divided as follows: 5 minutes of treatment with OMEGO® without visual feedback, 3 minutes of break, and additional 5 minutes of treatment with OMEGO® plus visual feedback | Device: OMEGO®<br>* Lower limb rehabilitation with and without visual feedback<br>|
| Experimental: Group B (visual feedback-no visual feedback)<br>Participants in group B (6 patients with sABI and 6 healthy controls), will perform a single rehabilitation session with OMEGO®. In total, they will perform 18 minutes divided as follows: 5 minutes of treatment with OMEGO® plus visual feedback, 3 minutes of break, and additional 5 minutes of treatment with OMEGO® without visual feedback | Device: OMEGO®<br>* Lower limb rehabilitation with and without visual feedback<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Symmetry after the performance of the motor task | The symmetry between lower limbs will be evaluated, comparing the percentage of movement between limbs. | Change from baseline at T4 [after 18 minutes] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain connectivity | Assessment of brain connectivity will be performed by evaluating the EEG | 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 | Electrodermal activity assessment will be performed using the E4 wearable medical device (Empatica) | 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 | Heart Rate Variability assessment will be performed using the E4 wearable medical device (Empatica) | Baseline [T0]; after 5 minutes [training1, T1], after 8 minutes [rest, T2]; after 13 minutes [training2,T3] and after 18 minutes [rest, T4] | 
| Change of Proprioception | The proprioception of lower limbs will be evaluated by asking the patient to reach with the lower limb an indicated position | Change from baseline at T4 [after 18 minutes] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acquired brain injury, traumatic, virtual reality, cognitive function, rehabilitation, disability, lower limb, personalized medicine