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Brain InjuriesNCT05179330

Visual Feedback in Lower Limb Rehabilitation

A study testing OMEGO® in people with Brain Injuries and Brain Injuries, Traumatic, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
What is being tested?
OMEGO®
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteItaly
Study dates
13 Oct 2020to 31 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

    Rome, 00168

Other trials in Italy

About this study

Official title: 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.

Read more

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.

Being tested
OMEGO®
Keywords
acquired brain injury, traumatic, virtual reality, cognitive function, rehabilitation, disability, lower limb, personalized medicine
Medical subject headings
Brain Injuries, Brain Injuries, Traumatic, Cerebrovascular Trauma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OMEGO®Device

    Lower limb rehabilitation with and without visual feedback

Study groups in NCT05179330
Study groupRoleWhat they receive
Group A (no visual feedback-visual feedback)ExperimentalParticipants 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
Receives: Device: OMEGO®
Group B (visual feedback-no visual feedback)ExperimentalParticipants 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
Receives: Device: OMEGO®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change from baseline at T4 [after 18 minutes]

Secondary outcomes (4)

  1. Brain connectivity

    Assessment of brain connectivity will be performed by evaluating the EEG

    Measured: Baseline [T0]; after 5 minutes [training1, T1], after 8 minutes [rest, T2]; after 13 minutes [training2,T3] and after 18 minutes [rest, T4]

  2. Electrodermal activity

    Electrodermal activity assessment will be performed using the E4 wearable medical device (Empatica)

    Measured: Baseline [T0]; after 5 minutes [training1, T1], after 8 minutes [rest, T2]; after 13 minutes [training2,T3] and after 18 minutes [rest, T4]

  3. Heart Rate Variability

    Heart Rate Variability assessment will be performed using the E4 wearable medical device (Empatica)

    Measured: Baseline [T0]; after 5 minutes [training1, T1], after 8 minutes [rest, T2]; after 13 minutes [training2,T3] and after 18 minutes [rest, T4]

  4. Change of Proprioception

    The proprioception of lower limbs will be evaluated by asking the patient to reach with the lower limb an indicated position

    Measured: Change from baseline at T4 [after 18 minutes]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2022
  2. Study start13 Oct 2020
  3. Primary completion30 Apr 2021
  4. Study completion31 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05179330
Sponsor's protocol ID
3515
Status last verified
Feb 2024
First submitted
2 Dec 2021
Last updated
22 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Maegele M. Traumatic brain injury in 2017: exploring the secrets of concussion. Lancet Neurol. 2018 Jan;17(1):13-15. doi: 10.1016/S1474-4422(17)30419-2. Epub 2017 Dec 16. No abstract available.

    PubMed 29262993

  • Horn SD, Corrigan JD, Dijkers MP. Traumatic Brain Injury Rehabilitation Comparative Effectiveness Research: Introduction to the Traumatic Brain Injury-Practice Based Evidence Archives Supplement. Arch Phys Med Rehabil. 2015 Aug;96(8 Suppl):S173-7. doi: 10.1016/j.apmr.2015.03.027.

    PubMed 26212395

  • Aulisio MC, Han DY, Glueck AC. Virtual reality gaming as a neurorehabilitation tool for brain injuries in adults: A systematic review. Brain Inj. 2020 Aug 23;34(10):1322-1330. doi: 10.1080/02699052.2020.1802779. Epub 2020 Aug 13.

    PubMed 32791020

  • Nudo RJ. Adaptive plasticity in motor cortex: implications for rehabilitation after brain injury. J Rehabil Med. 2003 May;(41 Suppl):7-10. doi: 10.1080/16501960310010070.

    PubMed 12817650

  • Laudisio A, Giovannini S, Finamore P, Loreti C, Vannetti F, Coraci D, Incalzi RA, Zuccal G, Macchi C, Padua L; Mugello Study Working Group. Muscle strength is related to mental and physical quality of life in the oldest old. Arch Gerontol Geriatr. 2020 Jul-Aug;89:104109. doi: 10.1016/j.archger.2020.104109. Epub 2020 May 15.

    PubMed 32460125

  • Castelli L, De Giglio L, Haggiag S, Traini A, De Luca F, Ruggieri S, Prosperini L. Premorbid functional reserve modulates the effect of rehabilitation in multiple sclerosis. Neurol Sci. 2020 May;41(5):1251-1257. doi: 10.1007/s10072-019-04237-z. Epub 2020 Jan 9.

    PubMed 31919697

  • Levin MF, Weiss PL, Keshner EA. Emergence of virtual reality as a tool for upper limb rehabilitation: incorporation of motor control and motor learning principles. Phys Ther. 2015 Mar;95(3):415-25. doi: 10.2522/ptj.20130579. Epub 2014 Sep 11.

    PubMed 25212522

  • Mukamel R, Ekstrom AD, Kaplan J, Iacoboni M, Fried I. Single-neuron responses in humans during execution and observation of actions. Curr Biol. 2010 Apr 27;20(8):750-6. doi: 10.1016/j.cub.2010.02.045. Epub 2010 Apr 8.

    PubMed 20381353

  • Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4.

    PubMed 29156493

  • Milgram, P.; Kishino, F. A taxonomy of mixed reality visual displays. IEICE Trans. Inform. Syst. 1994, 77, 1321-1329.

  • Yin C, Hsueh YH, Yeh CY, Lo HC, Lan YT. A Virtual Reality-Cycling Training System for Lower Limb Balance Improvement. Biomed Res Int. 2016;2016:9276508. doi: 10.1155/2016/9276508. Epub 2016 Mar 6.

    PubMed 27034953

  • Kleim JA, Jones TA. Principles of experience-dependent neural plasticity: implications for rehabilitation after brain damage. J Speech Lang Hear Res. 2008 Feb;51(1):S225-39. doi: 10.1044/1092-4388(2008/018).

    PubMed 18230848

  • Padua L, Imbimbo I, Aprile I, Loreti C, Germanotta M, Coraci D, Piccinini G, Pazzaglia C, Santilli C, Cruciani A, Carrozza MC; FDG Robotic Rehabilitation Groupdagger. Cognitive reserve as a useful variable to address robotic or conventional upper limb rehabilitation treatment after stroke: a multicentre study of the Fondazione Don Carlo Gnocchi. Eur J Neurol. 2020 Feb;27(2):392-398. doi: 10.1111/ene.14090. Epub 2019 Oct 18.

    PubMed 31536677

  • Banz R, Bolliger M, Colombo G, Dietz V, Lunenburger L. Computerized visual feedback: an adjunct to robotic-assisted gait training. Phys Ther. 2008 Oct;88(10):1135-45. doi: 10.2522/ptj.20070203. Epub 2008 Sep 4.

    PubMed 18772279

Questions about this trial

What is this clinical trial studying?

A study testing OMEGO® in people with Brain Injuries and Brain Injuries, Traumatic, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Symmetry after the performance of the motor task (time frame: Change from baseline at T4 [after 18 minutes]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05179330, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.

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