Hospital Vall D'Hebrón
Barcelona, 08035, Spain
Location status: Recruiting
Location contact
Marat Fernandez-Lobera, PhD
CONTACT
Susana Rodriguez Gonzalez, MD
CONTACT
NCT Number: NCT06627387
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 d'Hebrón 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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Barcelona, 08035, Spain
Location status: Recruiting
Marat Fernandez-Lobera, PhD
CONTACT
Susana Rodriguez Gonzalez, MD
CONTACT
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 user's 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 user's 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 protocol's 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 user's 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 user's 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 user's height. The aim is similar, though: The user must stand in a tip-toe position to move the bridge higher and connect the platforms.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention will be carried out in two phases. The first phase will take place at Vall d'Hebron Hospital, where patients will undergo balance training under the supervision of a physiotherapist. The scheduled dose will be 60 minutes daily, 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. For this task, the involvement of a family member as a training partner will be essential. Relatives will receive training on using the system in the hospital and must be present whenever the patient undergoes the training at home. Three assessments will be carried out during the six weeks of the study. At the beginning of the intervention ("Day 0" ), a second is once the hospital intervention has been carried out ("Week 4" ), and the last is once the home intervention has been carried out ("Week 6").
Other names: Personalized Health Assistance SystEM (PHASE)
Time frame: "Week 4" "Week 6"
The System Usability Scale is a reliable tool for measuring usability. It consists of a 10-item questionnaire with five response options for respondents, from Strongly Agree to Disagree Strongly. A value above 68 points is considered acceptable.
Time frame: "Week 4" "Week 6"
The instrument is a self-administered questionnaire assessing user satisfaction with assistive technology product and associated services.
Time frame: "Week 4" "Week 6"
The scales of the questionnaire cover comprehensive impression of user experience. Both classical usability aspects (efficiency, perspicuity, dependability) and user experience (originality stimulation) are measured. The items are scaled from -3 to +3. Thus, -3 represents the most negative answer, 0 a neutral answer, and +3 the most positive answer.
Time frame: "Week 6"
Time the Augmentad reality system is used in comparision to the scheduled dosage.
Time frame: "Week 4"
Total sessions scheduled for therapy compared to the number of sessions attended
Time frame: "Day 0" "Week 4" "Week 6"
Questions to assess the attitude towards the system and to gather data on privacy and feeling of stigma.
Time frame: "Day 0" "Week 4" "Week 6"
The Berg Balance Scale is a 14-item scale that assesses balance and fall risk in adults. Patients receive a score from 0-4 on their ability to meet these balance dimensions. A global score can be calculated out of 56. A score of 0 represents an inability to complete the item, and a score of 56 represents the ability to independently complete the item.
Time frame: "Day 0" "Week 4" "Week 6"
Quantitative static balance assement. It will be assessed using Ned SVE/IBE system for postural assessment.
Time frame: "Day 0" "Week 4" "Week 6"
The Five Times Sit to Stand Test is a highly reliable tool for assessing lower limbs strengh and balance control and is used to detect risk of fall in enderly and stroke patients. In this test the participants are instructed to stand up from a chair five times as fast as possible.
Time frame: "Day 0" "Week 4" "Week 6"
&-item self-report measure in wich patients rate their balance confidence for performing activities.
Time frame: "Day 0" "Week 4" "Week 6"
It is a self-report survey that measures quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is scored on a 5-level severity ranking that ranges from "No problems" to "Extreme problems."
Time frame: "Day 0"
Cognitive test validated as a highly sensitive tool for early detection of mild cognitive impairment. MoCA assesses short term memory, visuospacial abilities, executive functions, attention, concentration and working memory, and orientation to time and place.
Contact information is provided by the study sponsor or research team.
Marta Fernandez-Lobera, PhD
CONTACT
Susana Rodriguez Gonzalez, MD
CONTACT
Hospital Universitari Vall d'Hebron Research Institute
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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