Clinical trial NCT05179330: Visual Feedback in Lower Limb Rehabilitation
Official title: Visual Feedback in Lower Limb Rehabilitation: the Alpha and the OMEGO®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injuries
Brain Injuries, Traumatic
Brain Injuries, Vascular
Keywords: acquired brain injury
traumatic
virtual reality
cognitive function
rehabilitation
disability
lower limb
personalized medicine
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of Symmetry after the performance of the motor task
timeFrame: Change from baseline at T4 [after 18 minutes]
Secondary outcomes:
measure: Brain connectivity
timeFrame: Baseline [T0]; after 5 minutes [training1, T1], after 8 minutes [rest, T2]; after 13 minutes [training2,T3] and after 18 minutes [rest, T4]
measure: Electrodermal activity
timeFrame: Baseline [T0]; after 5 minutes [training1, T1], after 8 minutes [rest, T2]; after 13 minutes [training2,T3] and after 18 minutes [rest, T4]
measure: Heart Rate Variability
timeFrame: Baseline [T0]; after 5 minutes [training1, T1], after 8 minutes [rest, T2]; after 13 minutes [training2,T3] and after 18 minutes [rest, T4]
measure: Change of Proprioception
timeFrame: Change from baseline at T4 [after 18 minutes]
Other outcomes:
Locations:
city: Rome
country: Italy
facility: UOC Neuroriabilitazione ad Alta Intensità, Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitaria A. Gemelli IRCCS
name: Augusto Fusco, MD, phD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Milgram, P.; Kishino, F. A taxonomy of mixed reality visual displays. IEICE Trans. Inform. Syst. 1994, 77, 1321-1329.
citation: 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.
citation: 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).
citation: 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.
citation: 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.