Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627387
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
A Low-Cost Balance Training Platform Using Augmented Reality in Neurorehabilitation a Usability Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Low-Cost Balance Training Platform Using Augmented Reality in Neurorehabilitation a Usability Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to assess the Usability adherence acceptance and security of an augmented reality platform for balance training in patients with balance disorders due to degenerative injuries or cerebrovascular diseases
The main questions it aims to answer are
Is the augmented reality system usable acceptable and safe with good adherence
Does the system improve the balance in our population
Participants will be asked to assist at Vall dHebrón Hospital where patients will undergo balance training under the supervision of a physiotherapist three days a week for four weeks
If the patients meet the inclusion criteria the intervention will be extended for two more weeks at home
The main questions it aims to answer are
Is the augmented reality system usable acceptable and safe with good adherence
Does the system improve the balance in our population
Participants will be asked to assist at Vall dHebrón Hospital where patients will undergo balance training under the supervision of a physiotherapist three days a week for four weeks
If the patients meet the inclusion criteria the intervention will be extended for two more weeks at home
Detailed Description:
2 INTERVENTION The first phase of the intervention will last four weeks and will be done in the hospital After this intervention if the patients meet the inclusion criteria they will be enrolled in the second phase which will be done at the patients home for two additional weeks Three assessments will be performed during the study The first one Day 0 will be assessed before starting the treatment the second one will be done Week 4 directly after the intervention at a hospital setting and the last one Week 6 after the home intervention The intervention will be conducted in 1-hour sessions three times a week for four weeks performing different exercises using an augmented reality platform accessed through RGSweb If the patients continue the intervention at home a three-session training for two weeks will be conducted in the presence of a patients relative who will accept to be the training partner
3 EQUIPMENT AND TECHNICAL SPECIFICATIONS RGSweb can be used with any computer or device with a camera However our target users are patients who might have visibility issues due to old age Therefore bigger screens will be used to enhance the patients visibility Additional screen support will be required to hold the monitor
There are three protocols in RGSweb
Twister Buddy It has been developed for balance training which involves a series of levels intended to strengthen the muscles crucial for maintaining upright posture notably those in the legs The aim is to improve stability and help prevent falls
Levels The user will have to shift their weight from one leg to the other while doing different exercises such as touching targets with their hands and feet or taking steps
All levels will start with a calibration phase to ensure the user is in the correct position
Level 1 -Balance In this level two colored columns will be displayed on the screen while user motion trackers will also be reflected on the screen The goal is to align the trackers with the same color column
Level 2 - Balance Hands In addition to the balance movement from Level 1 a target will be displayed on the screen The user must maintain balance on the highlighted column while reaching the target with their hand
Level 3 - Side Steps To initiate the user must have their feet on a square-like target at the bottom center of the screen After that a target will appear adjacent to the square The users task is to adjust their foot position so that both the toe and heel are inside this target area Once achieved the user must return their foot to the original position within the square prompting the appearance of the next target for the opposite foot
Level 4 - Front steps Similar to level 4 the user begins by positioning both feet on the square target Then an arrow will appear above one of the users feet indicating the direction of the step either forward or backward Once the user moves the designated foot past a predefined threshold value currently indicated by a slider the arrow will disappear prompting the user to return both feet to the square Subsequently an arrow will appear above the other foot indicating the direction for the next step The direction of the steps is randomized for each interaction
Level 5 -- Balance Hands Feet This is the next step from level 4 It starts with Balance then the target for the hand and finally the target for the opposite foot Like level 2 the user must maintain only the bottom part hip and under inside the column while reaching the target with their hand and foot
Costume Party This protocols main focus is sit-to-stand The levels of this exercise follow different steps to stand up from a chair starting with leaning forward
Levels All levels will start with a calibration phase to ensure the user is in the correct position
The objective is to dress up for a costume party using a reference shown at the bottom right of the screen Various costume parts will appear on a bar and move across the screen The user needs to catch the right parts for their costume and put them on Once the costume is complete there will be a few seconds to admire it before the process starts over with a new costume reference
Level 1-Lean Forward In this level the costume elements move from one side of the screen to another at the users eye level
To grab the element they must lean forward enough to surpass a threshold value defined by a slider
Level 2-Flex Knees The user starts the motion of standing up by flexing the knees and rising slightly from the chair
The elements will appear close to the users head and leaning forward is unnecessary
Level 3-Stand Up This level is similar to level 2 but the elements are positioned higher requiring the user to stand up to reach them
Gentle Giant This exercise targets less-impaired patients who can perform sit-to-stand and balance training exercises
Levels
The aim is to allow the elements to move from one platform to another following color coding To do so the user will act as a bridge between the different floors
All levels will start with a calibration phase to ensure the user is in the correct position
Level 1-Squats In this level the user must move the elements from one platform to another by moving the bridge up and down that is by squatting to go down and standing again to come up
Level 2-Tip-Toe In this level one platform will be higher than the users height The aim is similar though The user must stand in a tip-toe position to move the bridge higher and connect the platforms
3 EQUIPMENT AND TECHNICAL SPECIFICATIONS RGSweb can be used with any computer or device with a camera However our target users are patients who might have visibility issues due to old age Therefore bigger screens will be used to enhance the patients visibility Additional screen support will be required to hold the monitor
There are three protocols in RGSweb
Twister Buddy It has been developed for balance training which involves a series of levels intended to strengthen the muscles crucial for maintaining upright posture notably those in the legs The aim is to improve stability and help prevent falls
Levels The user will have to shift their weight from one leg to the other while doing different exercises such as touching targets with their hands and feet or taking steps
All levels will start with a calibration phase to ensure the user is in the correct position
Level 1 -Balance In this level two colored columns will be displayed on the screen while user motion trackers will also be reflected on the screen The goal is to align the trackers with the same color column
Level 2 - Balance Hands In addition to the balance movement from Level 1 a target will be displayed on the screen The user must maintain balance on the highlighted column while reaching the target with their hand
Level 3 - Side Steps To initiate the user must have their feet on a square-like target at the bottom center of the screen After that a target will appear adjacent to the square The users task is to adjust their foot position so that both the toe and heel are inside this target area Once achieved the user must return their foot to the original position within the square prompting the appearance of the next target for the opposite foot
Level 4 - Front steps Similar to level 4 the user begins by positioning both feet on the square target Then an arrow will appear above one of the users feet indicating the direction of the step either forward or backward Once the user moves the designated foot past a predefined threshold value currently indicated by a slider the arrow will disappear prompting the user to return both feet to the square Subsequently an arrow will appear above the other foot indicating the direction for the next step The direction of the steps is randomized for each interaction
Level 5 -- Balance Hands Feet This is the next step from level 4 It starts with Balance then the target for the hand and finally the target for the opposite foot Like level 2 the user must maintain only the bottom part hip and under inside the column while reaching the target with their hand and foot
Costume Party This protocols main focus is sit-to-stand The levels of this exercise follow different steps to stand up from a chair starting with leaning forward
Levels All levels will start with a calibration phase to ensure the user is in the correct position
The objective is to dress up for a costume party using a reference shown at the bottom right of the screen Various costume parts will appear on a bar and move across the screen The user needs to catch the right parts for their costume and put them on Once the costume is complete there will be a few seconds to admire it before the process starts over with a new costume reference
Level 1-Lean Forward In this level the costume elements move from one side of the screen to another at the users eye level
To grab the element they must lean forward enough to surpass a threshold value defined by a slider
Level 2-Flex Knees The user starts the motion of standing up by flexing the knees and rising slightly from the chair
The elements will appear close to the users head and leaning forward is unnecessary
Level 3-Stand Up This level is similar to level 2 but the elements are positioned higher requiring the user to stand up to reach them
Gentle Giant This exercise targets less-impaired patients who can perform sit-to-stand and balance training exercises
Levels
The aim is to allow the elements to move from one platform to another following color coding To do so the user will act as a bridge between the different floors
All levels will start with a calibration phase to ensure the user is in the correct position
Level 1-Squats In this level the user must move the elements from one platform to another by moving the bridge up and down that is by squatting to go down and standing again to come up
Level 2-Tip-Toe In this level one platform will be higher than the users height The aim is similar though The user must stand in a tip-toe position to move the bridge higher and connect the platforms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None