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Visual Feedback in Lower Limb Rehabilitation

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
OMEGO®
Sponsored by
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring acquired brain injury, traumatic, virtual reality, cognitive function, rehabilitation, disability, lower limb, personalized medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A (no visual feedback-visual feedback)

Group B (visual feedback-no visual feedback)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Brain connectivity
Assessment of brain connectivity will be performed by evaluating the EEG
Electrodermal activity
Electrodermal activity assessment will be performed using the E4 wearable medical device (Empatica)
Heart Rate Variability
Heart Rate Variability assessment will be performed using the E4 wearable medical device (Empatica)
Change of Proprioception
The proprioception of lower limbs will be evaluated by asking the patient to reach with the lower limb an indicated position

Full Information

First Posted
December 2, 2021
Last Updated
January 5, 2022
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT05179330
Brief Title
Visual Feedback in Lower Limb Rehabilitation
Official Title
Visual Feedback in Lower Limb Rehabilitation: the Alpha and the OMEGO®
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Brain Injuries, Traumatic, Brain Injuries, Vascular
Keywords
acquired brain injury, traumatic, virtual reality, cognitive function, rehabilitation, disability, lower limb, personalized medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (no visual feedback-visual feedback)
Arm Type
Experimental
Arm Description
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
Arm Title
Group B (visual feedback-no visual feedback)
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
OMEGO®
Intervention Description
Lower limb rehabilitation with and without visual feedback
Primary Outcome Measure Information:
Title
Change of Symmetry after the performance of the motor task
Description
The symmetry between lower limbs will be evaluated, comparing the percentage of movement between limbs.
Time Frame
Change from baseline at T4 [after 18 minutes]
Secondary Outcome Measure Information:
Title
Brain connectivity
Description
Assessment of brain connectivity will be performed by evaluating the EEG
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]
Title
Electrodermal activity
Description
Electrodermal activity assessment will be performed using the E4 wearable medical device (Empatica)
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]
Title
Heart Rate Variability
Description
Heart Rate Variability assessment will be performed using the E4 wearable medical device (Empatica)
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]
Title
Change of Proprioception
Description
The proprioception of lower limbs will be evaluated by asking the patient to reach with the lower limb an indicated position
Time Frame
Change from baseline at T4 [after 18 minutes]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Augusto Fusco, MD, phD
Organizational Affiliation
Fondazione Policlinico Universitaria A. Gemelli IRCCS
Official's Role
Study Director
Facility Information:
Facility Name
UOC Neuroriabilitazione ad Alta Intensità, Fondazione Policlinico Universitario A. Gemelli IRCCS
City
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Visual Feedback in Lower Limb Rehabilitation

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