Skip to main content
OpenTrials
Completed

NCT Number: NCT05179330

Visual Feedback in Lower Limb Rehabilitation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UOC Neuroriabilitazione ad Alta Intensità, Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OMEGO®

Device

Lower limb rehabilitation with and without visual feedback

Primary outcomes

  1. Change of Symmetry after the performance of the motor task

    Time frame: Change from baseline at T4 [after 18 minutes]

    The symmetry between lower limbs will be evaluated, comparing the percentage of movement between limbs.

Secondary outcomes

  1. Brain connectivity

    Time frame: 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

  2. Electrodermal activity

    Time frame: 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)

  3. Heart Rate Variability

    Time frame: 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)

  4. Change of Proprioception

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2022
Registry last updated
Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.