Brain Injuries Clinical Trial
Official title:
Visual Feedback in Lower Limb Rehabilitation: the Alpha and the OMEGO®
NCT number | NCT05179330 |
Other study ID # | 3515 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 13, 2020 |
Est. completion date | October 31, 2021 |
Verified date | February 2024 |
Source | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | October 31, 2021 |
Est. primary completion date | April 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | UOC Neuroriabilitazione ad Alta Intensità, Fondazione Policlinico Universitario A. Gemelli IRCCS | Rome |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
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* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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] | |
Secondary | 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] | |
Secondary | 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] | |
Secondary | 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] |
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