NCT05179330

Visual Feedback in Lower Limb Rehabilitation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Brain Injuries
• Brain Injuries, Traumatic
• Brain Injuries, Vascular

Interventions

Type	Name	Description
DEVICE	OMEGO®	Lower limb rehabilitation with and without visual feedback

Timeline

• Start date: 2020-10-13
• Primary completion: 2021-04-30
• Completion: 2021-10-31
• First posted: 2022-01-05
• Last updated: 2024-02-22

Locations

1 site across 1 country: Italy