Postural BalanceNCT06627387
A Low-Cost Balance Training Platform Using Augmented Reality in Neurorehabilitation: a Usability Study
A study testing Balance Training Using Augmented Reality in people with Postural Balance and Cerebrovascular Disorders, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postural Balance, Cerebrovascular Disorders, Neurodegenerative Diseases
- What is being tested?
- Balance Training Using Augmented Reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 6 Aug 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Balance impairment due cerebrovascular diseases or neurodegenerative diseases.
- Being able to mantain standing for 2 minuts without assistance.
- Berg scale ≥21
- Age ≥18
- Signing informed consent
- To have a training partner during the exercises at home.
Show all 9Show fewer
- No fall attempt during hospital intervention
- No have enough space to train safely at their home.
- Being familiar with technological devices such a laptop, tablets or inteligent cellphones.
Who cannot join
- The presence of a condition or abnormality that could compromise the patient's safety.
- Severe cognitive impairments tha prevent the execution of the xperiment (MoCA <19)
- Presence of sensory aphasia.
- Diagnostic of conduct disorders.
- Presence of severe neglect.
- Spasticity =4 in MAS lower limb.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Vall D'Hebrón
Barcelona, Barcelona, 08035
Susana Rodriguez Gonzalez, MD, 607609067, susanarodriguezgonzalez@vallhebron.cat
Marat Fernandez-Lobera, PhD, 677517345, marta.fernandez@vhir.org
About this study
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.
Read the detailed description
- 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 patient's 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 patient's relative, who will accept to be the training partner.
- 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 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.
- Conditions
- Postural Balance, Cerebrovascular Disorders, Neurodegenerative Diseases, Augmented Reality, Neurological Rehabilitation
- Being tested
- Balance Training Using Augmented Reality
- Keywords
- Augmented Reality, Postural balance, Neurological Rehabilitation
- Medical subject headings
- Cerebrovascular Disorders, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance Training Using Augmented RealityOther
Also called Personalized Health Assistance SystEM (PHASE)
The intervention will be carried out in two phases. The first phase will take place at Vall d\&#39;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").
| Study group | Role | What they receive |
|---|---|---|
| Balance training | Experimental | 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 a day, 3 days a week for 4 weeks. If the patients meet the inclusion criteria, the intervention will be extended for two more weeks at home. Receives: Other: Balance Training Using Augmented Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale (SUS)
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.
Measured: "Week 4" "Week 6"
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)
The instrument is a self-administered questionnaire assessing user satisfaction with assistive technology product and associated services.
Measured: "Week 4" "Week 6"
User Esperience Questionnaire (UEQ)
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.
Measured: "Week 4" "Week 6"
Adherence (Home)
Time the Augmentad reality system is used in comparision to the scheduled dosage.
Measured: "Week 6"
Adherence (Hospital)
Total sessions scheduled for therapy compared to the number of sessions attended
Measured: "Week 4"
Ad-hoc questions
Questions to assess the attitude towards the system and to gather data on privacy and feeling of stigma.
Measured: "Day 0" "Week 4" "Week 6"
Secondary outcomes (5)
Berg Balance Scale
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.
Measured: "Day 0" "Week 4" "Week 6"
Postural Sway
Quantitative static balance assement. It will be assessed using Ned SVE/IBE system for postural assessment.
Measured: "Day 0" "Week 4" "Week 6"
Five Times Sit to Stand Test (FTSS)
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.
Measured: "Day 0" "Week 4" "Week 6"
The Activities-specific Balance Confidence (ABC) Scale.
\&amp;-item self-report measure in wich patients rate their balance confidence for performing activities.
Measured: "Day 0" "Week 4" "Week 6"
The EuroQol-5 Dimension-5 Level (EQ-5D-5L)
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."
Measured: "Day 0" "Week 4" "Week 6"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start6 Aug 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postural BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- usability study
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Eodyne Systems SL
- Responsible party
- Sponsor
- Investigators
- Susana Rodriguez Gonzalez, MD, Principal investigator, VHIR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627387
- Sponsor's protocol ID
- PR(AT)309/2024
- Status last verified
- Oct 2024
- First submitted
- 20 Aug 2024
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are the only center involved in the studdy and we don\'t consider to share patients data with other researchers.
Publications
Truijen S, Abdullahi A, Bijsterbosch D, van Zoest E, Conijn M, Wang Y, Struyf N, Saeys W. Effect of home-based virtual reality training and telerehabilitation on balance in individuals with Parkinson disease, multiple sclerosis, and stroke: a systematic review and meta-analysis. Neurol Sci. 2022 May;43(5):2995-3006. doi: 10.1007/s10072-021-05855-2. Epub 2022 Feb 17.
PubMed 35175439Lim JH, Lee HS, Song CS. Home-based rehabilitation programs on postural balance, walking, and quality of life in patients with stroke: A single-blind, randomized controlled trial. Medicine (Baltimore). 2021 Sep 3;100(35):e27154. doi: 10.1097/MD.0000000000027154.
PubMed 34477171Keller JL, Bastian AJ. A home balance exercise program improves walking in people with cerebellar ataxia. Neurorehabil Neural Repair. 2014 Oct;28(8):770-8. doi: 10.1177/1545968314522350. Epub 2014 Feb 13.
PubMed 24526707Lei C, Sunzi K, Dai F, Liu X, Wang Y, Zhang B, He L, Ju M. Effects of virtual reality rehabilitation training on gait and balance in patients with Parkinson's disease: A systematic review. PLoS One. 2019 Nov 7;14(11):e0224819. doi: 10.1371/journal.pone.0224819. eCollection 2019.
PubMed 31697777Iruthayarajah J, McIntyre A, Cotoi A, Macaluso S, Teasell R. The use of virtual reality for balance among individuals with chronic stroke: a systematic review and meta-analysis. Top Stroke Rehabil. 2017 Jan;24(1):68-79. doi: 10.1080/10749357.2016.1192361. Epub 2016 Jun 16.
PubMed 27309680
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Low-Cost Balance Training Platform Using Augmented Reality in Neurorehabilitation: a Usability Study
- ClinicalTrials.gov ID
- NCT06627387
- Acronym / sponsor ID
- PR(AT)309/2024
- Conditions
- Postural Balance, Cerebrovascular Disorders, Neurodegenerative Diseases, Augmented Reality, Neurological Rehabilitation
- Keywords
- Augmented Reality, Postural balance, Neurological Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Eodyne Systems SL
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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 patient's 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 patient's relative, who will accept to be the training partner.
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- usability study
| Arm | Type | Receives |
|---|---|---|
| Balance training | Experimental | Other: Balance Training Using Augmented RealityThe 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 a day, 3 days a week for 4 weeks. If the patients meet the inclusion criteria, the intervention will be extended for two more weeks at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Balance impairment due cerebrovascular diseases or neurodegenerative diseases.
- Being able to mantain standing for 2 minuts without assistance.
- Berg scale ≥21
- Age ≥18
- Signing informed consent
Key exclusion criteria (6 listed)
- The presence of a condition or abnormality that could compromise the patient's safety.
- Severe cognitive impairments tha prevent the execution of the xperiment (MoCA <19)
- Presence of sensory aphasia.
- Diagnostic of conduct disorders.
- Presence of severe neglect.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance Training Using Augmented RealityAlso: Personalized Health Assistance SystEM (PHASE)The intervention will be carried out in two phases. The first phase will take place at Vall d\&#39;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 | Balance training |
Primary outcome
System Usability Scale (SUS)
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.
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)
Time frame: "Week 4" "Week 6"
The instrument is a self-administered questionnaire assessing user satisfaction with assistive technology product and associated services.
User Esperience Questionnaire (UEQ)
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.
Adherence (Home)
Time frame: "Week 6"
Time the Augmentad reality system is used in comparision to the scheduled dosage.
Adherence (Hospital)
Time frame: "Week 4"
Total sessions scheduled for therapy compared to the number of sessions attended
Ad-hoc questions
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.
5 secondary outcomes
Berg Balance Scale
Time frame: "Day 0" "Week 4" "Week 6"
Postural Sway
Time frame: "Day 0" "Week 4" "Week 6"
Five Times Sit to Stand Test (FTSS)
Time frame: "Day 0" "Week 4" "Week 6"
The Activities-specific Balance Confidence (ABC) Scale.
Time frame: "Day 0" "Week 4" "Week 6"
The EuroQol-5 Dimension-5 Level (EQ-5D-5L)
Time frame: "Day 0" "Week 4" "Week 6"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Background: PubMed 35175439Truijen S, Abdullahi A, Bijsterbosch D, van Zoest E, Conijn M, Wang Y, Struyf N, Saeys W. Effect of home-based virtual reality training and telerehabilitation on balance in individuals with Parkinson disease, multiple sclerosis, and stroke: a systematic review and meta-analysis. Neurol Sci. 2022 May;43(5):2995-3006. doi: 10.1007/s10072-021-05855-2. Epub 2022 Feb 17.
- Background: PubMed 34477171Lim JH, Lee HS, Song CS. Home-based rehabilitation programs on postural balance, walking, and quality of life in patients with stroke: A single-blind, randomized controlled trial. Medicine (Baltimore). 2021 Sep 3;100(35):e27154. doi: 10.1097/MD.0000000000027154.
- Background: PubMed 24526707Keller JL, Bastian AJ. A home balance exercise program improves walking in people with cerebellar ataxia. Neurorehabil Neural Repair. 2014 Oct;28(8):770-8. doi: 10.1177/1545968314522350. Epub 2014 Feb 13.
- Background: PubMed 31697777Lei C, Sunzi K, Dai F, Liu X, Wang Y, Zhang B, He L, Ju M. Effects of virtual reality rehabilitation training on gait and balance in patients with Parkinson's disease: A systematic review. PLoS One. 2019 Nov 7;14(11):e0224819. doi: 10.1371/journal.pone.0224819. eCollection 2019.
- Background: PubMed 27309680Iruthayarajah J, McIntyre A, Cotoi A, Macaluso S, Teasell R. The use of virtual reality for balance among individuals with chronic stroke: a systematic review and meta-analysis. Top Stroke Rehabil. 2017 Jan;24(1):68-79. doi: 10.1080/10749357.2016.1192361. Epub 2016 Jun 16.
- Individual participant dataSharing planned: No. We are the only center involved in the studdy and we don\'t consider to share patients data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susana Rodriguez Gonzalez, MD principal investigator
VHIR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Training Using Augmented Reality in people with Postural Balance and Cerebrovascular Disorders, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susana Rodriguez Gonzalez, MD (+34 607609067, susana.rodriguezgonzalez@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (SUS) (time frame: "Week 4" "Week 6"). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06627387, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.