Visual Feedback in Lower Limb Rehabilitation

February 21, 2024 updated by: PADUA LUCA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • UOC Neuroriabilitazione ad Alta Intensità, Fondazione Policlinico Universitario A. Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (no visual feedback-visual feedback)
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®
Lower limb rehabilitation with and without visual feedback
Experimental: Group B (visual feedback-no visual feedback)
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®
Lower limb rehabilitation with and without visual feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline at T4 [after 18 minutes]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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)
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
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)
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
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
Change from baseline at T4 [after 18 minutes]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Study Director: Augusto Fusco, MD, phD, Fondazione Policlinico Universitaria A. Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2020

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

October 31, 2021

Study Registration Dates

First Submitted

December 2, 2021

First Submitted That Met QC Criteria

December 16, 2021

First Posted (Actual)

January 5, 2022

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3515

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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