Down Syndrome Immersive Physical ActivityIN DOWNNCT07668908
Immersive Virtual Reality Program in Down Syndrome
A study testing RVI_Experimental_Immersive Virtual Reality Exergame and RVI_ControGroup_Immersive Virtual Reality Exergame in people with Down Syndrome Immersive Physical Activity, run by University of Vigo at 1 site in Spain.
Trial summary
The presented project aims to bring immersive technology to individuals with Down syndrome (DS) through the development of innovative proposals for acquiring skills and abilities, and enhancing their capabilities by combining the motor and cognitive components so important for this group. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Down Syndrome Immersive Physical Activity
- What is being tested?
- RVI_Experimental_Immersive Virtual Reality Exergame and RVI_ControGroup_Immersive Virtual Reality Exergame
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jan 2026to 1 Jul 2026
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Mild to moderate intellectual disability as reported by parents
- Ability to follow simple verbal instructions in Spanish or Galician
- Adequate physical condition to engage in a high-intensity exercise program. .
Who cannot join
- Individuals who had participated in a high-intensity exercise program within the previous three months
- Those with concurrent medical conditions such as chronic arthritis, autism, unrepaired congenital heart defect; or a history of violent episodes, elopement, aggressive behavior, or antisocial conduct; presenting severe visual or auditory disturbances, vertigo, psychosis or uncontrolled epilepsy that would prevent the sessions being carried out.
- -
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Integration and Equal Opportunities for People With Down Syndrome: An Innovative Proposal Through Immersive Virtual Reality
The presented project aims to bring immersive technology to individuals with Down syndrome (DS) through the development of innovative proposals for acquiring skills and abilities, and enhancing their capabilities by combining the motor and cognitive components so important for this group. Various strategies have been used to improve the functionality (physical and cognitive) and quality of life of people with DS; however, one of the problems observed in practice is the low motivation and commitment to the interventions being implemented. In response to this problem, the use of technology and gamified environments has been proposed in recent years to make therapies more engaging. Therefore, this project arises with the objective of developing and evaluating the effects of an immersive intervention program on the physical and cognitive abilities of individuals with Down syndrome.
Read the detailed description
Down syndrome is the leading cause of intellectual disability and one of the most common genetic disorders, with an estimated prevalence of approximately 34,000 individuals in Spain and around 3,000 in Galicia. This population presents physical, motor, cognitive, and communication characteristics that affect functional ability and independence throughout life, including muscle hypotonia, difficulties in information processing, memory and attention impairments, and delayed language development.
Although various intervention strategies have been developed to improve functionality and quality of life in individuals with Down syndrome, a key limitation in practice is low motivation and adherence to traditional programs. In this context, technology-based and gamified interventions have shown potential to enhance engagement and improve motor outcomes, particularly balance and physical performance.
However, previous evidence has mainly focused on non-immersive exergaming, with limited research on immersive virtual reality approaches. Therefore, this study aims to develop and evaluate an immersive intervention program designed to improve physical and cognitive capacities in individuals with Down syndrome.
- Being tested
- RVI_Experimental_Immersive Virtual Reality Exergame, RVI_ControGroup_Immersive Virtual Reality Exergame
- Keywords
- physical activity, exergames, usability, accessibility, virtual reality, Training program
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVI_Experimental_Immersive Virtual Reality ExergameBehavioural
Participants assigned to the experimental group wil complete a 12-week immersive virtual reality (IVR) intervention based on high-intensity gamified physical exercise, with two (2) supervised sessions per week. The program will be conducted in a controlled environment within the participants' center gym and will be supervised by exercise and health professionals.
The exergames used will be:
Beat Saber (Beat Games) (6 sessions): Participants perform upper-limb and whole-body movements by hitting virtual targets in time with music, promoting coordination, reaction time, and cardiovascular fitness.
FitXR (14 sessions): A virtual reality training program based on high-intensity interval training (HIIT), boxing, and functional movement exercises. It enhances cardiovascular endurance, motor coordinat and cognitive engagement through structured tasks with progressively increasing difficulty levels. Alcove VR (1 session): Used as an initial familiarization and adaptat
RVI_ControGroup_Immersive Virtual Reality ExergameBehavioural
Participants assigned to the experimental group wil complete a 12-week immersive virtual reality (IVR) intervention based on high-intensity gamified physical exercise, with one (1) supervised sessions per week. The program will be conducted in a controlled environment within the participants' center gym and will be supervised by exercise and health professionals. The exergames used will be: Beat Saber (Beat Games) (3 sessions): Participants perform upper-limb and whole-body movements by hitting virtual targets in time with music, promoting coordination, reaction time, and cardiovascular fitness. FitXR (FitXR Ltd., London, UK) (7 sessions): A virtual reality training program based on high-intensity interval training (HIIT), boxing, and functional movement exercises. It enhances cardiovascular endurance, motor coordinat and cognitive engagement through structured tasks with progressively increasing difficulty levels. Alcove VR (1 session): Used as an initial familiarization and adaptat
| Study group | Role | What they receive |
|---|---|---|
| RVI_E_Immersive Virtual Reality Exergame | Experimental | Participants will complete a 12-week immersive virtual reality (VR) intervention based on high-intensity, gamified physical exercise, with two (2) supervised sessions per week. The program will take place in a controlled environment within the participants' center's gym and will be supervised by fitness and health professionals. Receives: Behavioral: RVI_Experimental_Immersive Virtual Reality Exergame |
| RVI_ControGroup_Immersive Virtual Reality Exergame | Placebo comparator | Participants will complete a 12-week immersive virtual reality (VR) intervention based on high-intensity, gamified physical exercise, with one (1) supervised sessions per week. The program will take place in a controlled environment within the participants' center's gym and will be supervised by fitness and health professionals. Receives: Behavioral: RVI_ControGroup_Immersive Virtual Reality Exergame |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Assessment body composition
Description: Body composition was assessed using the Tanita MC-780 bioelectrical impedance analyzer. Measured variables included fat mass (FM), fat-free mass (FFM), muscle mass (MM), total body water (TBW), and segmental body composition of the trunk and limbs.
Unit of Measurement:
Fat Mass (FM): kg Fat-Free Mass (FFM): kg Muscle Mass (MM): kg Total Body Water (TBW): kg Segmental Body Composition: kg
Interpretation: Higher FFM, MM, and TBW indicate better physical fitness. Lower FM indicates better body composition.
Measured: 12 weeks
Assessment usability
- System usability will be assessed using the System Usability Scale (SUS), a validated 10-item questionnaire. Scores range from 0 to 100, with higher scores indicating better usability.
Unit of Measure:
SUS score (0-100)
Interpretation:
Scores ≥68 indicate acceptable usability; scores >80 indicate excellent usability.
Measured: 12 weeks
Cognitive parameters: Executive function
Description: Clock Drawing Test (CDT) Participants are asked to draw an analog clock and set the hands to a specified time. Performance is scored using methods such as TRO and TCR, which evaluate the accuracy and organization of the drawing.
Unit of measurement
Total CDT score (scoring scale) ( 0-20 points)
Interpretation
Higher scores: better cognitive performance, particularly in executive and visuospatial functions Lower scores: possible impairment in planning, spatial organization, and other cognitive functions
Measured: 12 weeks
Assessment Aerobic endurance
2-Minute Step Test Participants march in place for 2 minutes, raising their knees to a specified height. The total number of correctly completed steps is recorded.
Unit of measurement Number of steps completed in 2 minutes Interpretation Higher scores: better aerobic capacity and physical fitness Lower scores: reduced endurance and lower cardiorespiratory fitness
Measured: 12 weeks
Health-related quality of life
Description:
Health-related quality of life will be assessed using the KidsLife-Down Questionnaire, a validated instrument for individuals with Down syndrome that evaluates eight domains of quality of life and provides standardized scores and percentiles.
Unit of Measure:
KidsLife-Down total standardized score (scale)
Interpretation:
Higher scores indicate better quality of life and well-being. Lower scores indicate greater limitations in quality of life and daily functioning.
Measured: 12 weeks
Assessment Safety and cybersickness symptoms
Safety and cybersickness symptoms will be assessed using the Simulator Sickness Questionnaire (SSQ). Higher scores indicate greater severity of cybersickness symptoms.
Unit of Measure:
SSQ total score
Interpretation:
Lower scores indicate better tolerability and safety; a score of 0 indicates no symptoms.
Measured: 12 weeks
Assessment user experience and engagement
User experience and engagement will be assessed using the Game Experience Questionnaire (GEQ - Post-Game Module). Items are rated from 0 to
Unit of Measure:
GEQ subscale scores (0-4)
Interpretation:
Higher scores indicate better experience for positive dimensions and poorer experience for negative dimensions.
Measured: 12 weeks
Cognitive parameters: processing speed
Description: Symbol Digit Modalities Test (SDMT) Participants match symbols to corresponding numbers using a reference key and complete as many correct pairings as possible within a time limit.
Unit of measurement
Number of correct responses (raw score)
Interpretation
Higher scores: better attention, faster processing speed, and higher cognitive efficiency Lower scores: reduced attention, slower processing speed, and poorer cognitive performance
Measured: 12 weeks
Assessment Dynamic balance
Timed Up and Go (TUG) Test The participant stands up from a chair, walks a set distance (usually 3 meters), turns, walks back, and sits down. The total time is recorded.
Unit of measurement Seconds (time to complete the test) Interpretation Lower times: better mobility, balance, and functional performance Higher times: impaired mobility, poorer balance, and increased risk of falls
Measured: 12 weeks
Assessment Upper body muscular strength
Handgrip Strength (Jamar Dynamometer)
Participants squeeze a Jamar hand dynamometer with maximum voluntary force, usually with the dominant hand or both hands depending on protocol.
Unit of measurement
- Kilograms (kg) Interpretation
- Higher values: greater muscular strength and better physical condition
- Lower values: reduced strength and poorer physical fitness
Measured: 12 weeks
Assessment Lower limb strength
Five Sit to stand Test (5STS) Participants perform five full squats as quickly and safely as possible. The total time to complete the five repetitions is recorded.
Unit of measurement Seconds (time to complete 5 squats) Interpretation Lower times: greater lower limb strength and better functional capacity Higher times: reduced strength and poorer functional performance
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start22 Jan 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down Syndrome Immersive Physical ActivityStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Vigo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José M. Cancela, University of Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668908
- Sponsor's protocol ID
- CEIHG 2023-00125
- Acronym
- IN DOWN
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration and Equal Opportunities for People With Down Syndrome: An Innovative Proposal Through Immersive Virtual Reality
- ClinicalTrials.gov ID
- NCT07668908
- Acronym / sponsor ID
- IN DOWN / CEIHG 2023-00125
- Keywords
- physical activity, exergames, usability, accessibility, virtual reality, Training program
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of VigoUniversity, hospital or other
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 25 Jun 2026 (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 presented project aims to bring immersive technology to individuals with Down syndrome (DS) through the development of innovative proposals for acquiring skills and abilities, and enhancing their capabilities by combining the motor and cognitive components so important for this group. Various strategies have been used to improve the functionality (physical and cognitive) and quality of life of people with DS; however, one of the problems observed in practice is the low motivation and commitment to the interventions being implemented. In response to this problem, the use of technology and gamified environments has been proposed in recent years to make therapies more engaging. Therefore, this project arises with the objective of developing and evaluating the effects of an immersive intervention program on the physical and cognitive abilities of individuals with Down syndrome.
Detailed description
Down syndrome is the leading cause of intellectual disability and one of the most common genetic disorders, with an estimated prevalence of approximately 34,000 individuals in Spain and around 3,000 in Galicia. This population presents physical, motor, cognitive, and communication characteristics that affect functional ability and independence throughout life, including muscle hypotonia, difficulties in information processing, memory and attention impairments, and delayed language development.
Although various intervention strategies have been developed to improve functionality and quality of life in individuals with Down syndrome, a key limitation in practice is low motivation and adherence to traditional programs. In this context, technology-based and gamified interventions have shown potential to enhance engagement and improve motor outcomes, particularly balance and physical performance.
However, previous evidence has mainly focused on non-immersive exergaming, with limited research on immersive virtual reality approaches. Therefore, this study aims to develop and evaluate an immersive intervention program designed to improve physical and cognitive capacities in individuals with Down syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RVI_E_Immersive Virtual Reality Exergame | Experimental | Behavioral: RVI_Experimental_Immersive Virtual Reality ExergameParticipants will complete a 12-week immersive virtual reality (VR) intervention based on high-intensity, gamified physical exercise, with two (2) supervised sessions per week. The program will take place in a controlled environment within the participants' center's gym and will be supervised by fitness and health professionals. |
| RVI_ControGroup_Immersive Virtual Reality Exergame | Placebo comparator | Behavioral: RVI_ControGroup_Immersive Virtual Reality ExergameParticipants will complete a 12-week immersive virtual reality (VR) intervention based on high-intensity, gamified physical exercise, with one (1) supervised sessions per week. The program will take place in a controlled environment within the participants' center's gym and will be supervised by fitness and health professionals. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Mild to moderate intellectual disability as reported by parents
- Ability to follow simple verbal instructions in Spanish or Galician
- Adequate physical condition to engage in a high-intensity exercise program. .
Key exclusion criteria (4 listed)
- Individuals who had participated in a high-intensity exercise program within the previous three months
- Those with concurrent medical conditions such as chronic arthritis, autism, unrepaired congenital heart defect; or a history of violent episodes, elopement, aggressive behavior, or antisocial conduct; presenting severe visual or auditory disturbances, vertigo, psychosis or uncontrolled epilepsy that would prevent the sessions being carried out.
- -
- -
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 |
|---|---|---|
| RVI_Experimental_Immersive Virtual Reality ExergameParticipants assigned to the experimental group wil complete a 12-week immersive virtual reality (IVR) intervention based on high-intensity gamified physical exercise, with two (2) supervised sessions per week. The program will be conducted in a controlled environment within the participants' center gym and will be supervised by exercise and health professionals. The exergames used will be: Beat Saber (Beat Games) (6 sessions): Participants perform upper-limb and whole-body movements by hitting virtual targets in time with music, promoting coordination, reaction time, and cardiovascular fitness. FitXR (14 sessions): A virtual reality training program based on high-intensity interval training (HIIT), boxing, and functional movement exercises. It enhances cardiovascular endurance, motor coordinat and cognitive engagement through structured tasks with progressively increasing difficulty levels. Alcove VR (1 session): Used as an initial familiarization and adaptat | Behavioural | RVI_E_Immersive Virtual Reality Exergame |
| RVI_ControGroup_Immersive Virtual Reality ExergameParticipants assigned to the experimental group wil complete a 12-week immersive virtual reality (IVR) intervention based on high-intensity gamified physical exercise, with one (1) supervised sessions per week. The program will be conducted in a controlled environment within the participants' center gym and will be supervised by exercise and health professionals. The exergames used will be: Beat Saber (Beat Games) (3 sessions): Participants perform upper-limb and whole-body movements by hitting virtual targets in time with music, promoting coordination, reaction time, and cardiovascular fitness. FitXR (FitXR Ltd., London, UK) (7 sessions): A virtual reality training program based on high-intensity interval training (HIIT), boxing, and functional movement exercises. It enhances cardiovascular endurance, motor coordinat and cognitive engagement through structured tasks with progressively increasing difficulty levels. Alcove VR (1 session): Used as an initial familiarization and adaptat | Behavioural | RVI_ControGroup_Immersive Virtual Reality Exergame |
Primary outcome
1. Assessment body composition
Time frame: 12 weeks
Description: Body composition was assessed using the Tanita MC-780 bioelectrical impedance analyzer. Measured variables included fat mass (FM), fat-free mass (FFM), muscle mass (MM), total body water (TBW), and segmental body composition of the trunk and limbs. Unit of Measurement: Fat Mass (FM): kg Fat-Free Mass (FFM): kg Muscle Mass (MM): kg Total Body Water (TBW): kg Segmental Body Composition: kg Interpretation: Higher FFM, MM, and TBW indicate better physical fitness. Lower FM indicates better body composition.
Assessment usability
Time frame: 12 weeks
1. System usability will be assessed using the System Usability Scale (SUS), a validated 10-item questionnaire. Scores range from 0 to 100, with higher scores indicating better usability. Unit of Measure: SUS score (0-100) Interpretation: Scores ≥68 indicate acceptable usability; scores >80 indicate excellent usability.
Cognitive parameters: Executive function
Time frame: 12 weeks
Description: Clock Drawing Test (CDT) Participants are asked to draw an analog clock and set the hands to a specified time. Performance is scored using methods such as TRO and TCR, which evaluate the accuracy and organization of the drawing. Unit of measurement Total CDT score (scoring scale) ( 0-20 points) Interpretation Higher scores: better cognitive performance, particularly in executive and visuospatial functions Lower scores: possible impairment in planning, spatial organization, and other cognitive functions
Assessment Aerobic endurance
Time frame: 12 weeks
2-Minute Step Test Participants march in place for 2 minutes, raising their knees to a specified height. The total number of correctly completed steps is recorded. Unit of measurement Number of steps completed in 2 minutes Interpretation Higher scores: better aerobic capacity and physical fitness Lower scores: reduced endurance and lower cardiorespiratory fitness
Health-related quality of life
Time frame: 12 weeks
Description: Health-related quality of life will be assessed using the KidsLife-Down Questionnaire, a validated instrument for individuals with Down syndrome that evaluates eight domains of quality of life and provides standardized scores and percentiles. Unit of Measure: KidsLife-Down total standardized score (scale) Interpretation: Higher scores indicate better quality of life and well-being. Lower scores indicate greater limitations in quality of life and daily functioning.
Assessment Safety and cybersickness symptoms
Time frame: 12 weeks
Safety and cybersickness symptoms will be assessed using the Simulator Sickness Questionnaire (SSQ). Higher scores indicate greater severity of cybersickness symptoms. Unit of Measure: SSQ total score Interpretation: Lower scores indicate better tolerability and safety; a score of 0 indicates no symptoms.
Assessment user experience and engagement
Time frame: 12 weeks
User experience and engagement will be assessed using the Game Experience Questionnaire (GEQ - Post-Game Module). Items are rated from 0 to Unit of Measure: GEQ subscale scores (0-4) Interpretation: Higher scores indicate better experience for positive dimensions and poorer experience for negative dimensions.
Cognitive parameters: processing speed
Time frame: 12 weeks
Description: Symbol Digit Modalities Test (SDMT) Participants match symbols to corresponding numbers using a reference key and complete as many correct pairings as possible within a time limit. Unit of measurement Number of correct responses (raw score) Interpretation Higher scores: better attention, faster processing speed, and higher cognitive efficiency Lower scores: reduced attention, slower processing speed, and poorer cognitive performance
Assessment Dynamic balance
Time frame: 12 weeks
Timed Up and Go (TUG) Test The participant stands up from a chair, walks a set distance (usually 3 meters), turns, walks back, and sits down. The total time is recorded. Unit of measurement Seconds (time to complete the test) Interpretation Lower times: better mobility, balance, and functional performance Higher times: impaired mobility, poorer balance, and increased risk of falls
Assessment Upper body muscular strength
Time frame: 12 weeks
Handgrip Strength (Jamar Dynamometer) Participants squeeze a Jamar hand dynamometer with maximum voluntary force, usually with the dominant hand or both hands depending on protocol. Unit of measurement * Kilograms (kg) Interpretation * Higher values: greater muscular strength and better physical condition * Lower values: reduced strength and poorer physical fitness
Assessment Lower limb strength
Time frame: 12 weeks
Five Sit to stand Test (5STS) Participants perform five full squats as quickly and safely as possible. The total time to complete the five repetitions is recorded. Unit of measurement Seconds (time to complete 5 squats) Interpretation Lower times: greater lower limb strength and better functional capacity Higher times: reduced strength and poorer functional performance
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 25 Jun 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RVI_Experimental_Immersive Virtual Reality Exergame and RVI_ControGroup_Immersive Virtual Reality Exergame in people with Down Syndrome Immersive Physical Activity, run by University of Vigo 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 3 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 25 Jun 2026. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Assessment body composition (time frame: 12 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2026.