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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05179330
Other study ID # 3515
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 13, 2020
Est. completion date October 31, 2021

Study information

Verified date February 2024
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date October 31, 2021
Est. primary completion date April 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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


Intervention

Device:
OMEGO®
Lower limb rehabilitation with and without visual feedback

Locations

Country Name City State
Italy UOC Neuroriabilitazione ad Alta Intensità, Fondazione Policlinico Universitario A. Gemelli IRCCS Rome

Sponsors (1)

Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (14)

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. — View 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. — View 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. — View 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. — View 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). — View 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. — View 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. — View 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. — View 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. — View Citation

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

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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from baseline at T4 [after 18 minutes]
Secondary Brain connectivity 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]
Secondary Electrodermal activity 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]
Secondary Heart Rate Variability 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]
Secondary Change of Proprioception 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]
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