Visual Feedback in Lower Limb Rehabilitation

NCT05179330 | Completed

• 1 other identifier: 3515
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries; Brain Injuries, Traumatic; Brain Injuries, Vascular

Keywords

acquired brain injury; traumatic; virtual reality; cognitive function; rehabilitation; disability; lower limb; personalized medicine

Outcome Measures

Primary Outcomes (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.

  Change from baseline at T4 [after 18 minutes]

Secondary Outcomes (4)

• Brain connectivity

  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

  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

  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

  Change from baseline at T4 [after 18 minutes]

Study Arms (2)

Group A (no visual feedback-visual feedback)

EXPERIMENTAL

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®

Group B (visual feedback-no visual feedback)

EXPERIMENTAL

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®

Interventions

OMEGO® DEVICE

Lower limb rehabilitation with and without visual feedback

Group A (no visual feedback-visual feedback); Group B (visual feedback-no visual feedback)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

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

Rome, 00168, Italy

Location

Related Publications (14)

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  PMID: 12817650 BACKGROUND

• 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.

  PMID: 32460125 BACKGROUND

• 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.

  PMID: 31919697 BACKGROUND

• 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.

  PMID: 25212522 BACKGROUND

• 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.

  PMID: 20381353 BACKGROUND

• 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.

  PMID: 29156493 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 27034953 BACKGROUND

• 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).

  PMID: 18230848 BACKGROUND

• 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.

  PMID: 31536677 BACKGROUND

• 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.

  PMID: 18772279 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic; Cerebrovascular Trauma

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Augusto Fusco, MD, phD

  Fondazione Policlinico Universitaria A. Gemelli IRCCS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: January 5, 2022
• Study Start: October 13, 2020
• Primary Completion: April 30, 2021
• Study Completion: October 31, 2021
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)