Visual Feedback in Lower Limb Rehabilitation

Not Applicable

Completed

• Conditions: Brain Injuries, Vascular; Brain Injuries; Brain Injuries, Traumatic
• Interventions: Device: OMEGO®

• Registration Number: NCT05179330
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-13
• Primary Completion: 2021-04-30
• Study Completion: 2021-10-31
• Study First Submitted: 2021-12-02
• Study First Submitted QC: 2021-12-16
• Study First Posted: 2022-01-05
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A (no visual feedback-visual feedback)	OMEGO®	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
Group B (visual feedback-no visual feedback)	OMEGO®	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (1)

UOC Neuroriabilitazione ad Alta Intensità, Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Rome, Italy