ParkinsonNCT05931692
Virtual Reality and Fear of Falling in Parkinson's Disease
An observational study of Parkinson and Parkinson Disease, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
Background: Falls are common in elderly individuals and those with neurological conditions like Parkinson's disease. Parkinson's disease causes postural instability and mobility issues that lead to falls and reduced quality of life. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson, Parkinson Disease, Parkinson's Disease and Parkinsonism
- What is being tested?
- Virtual reality, Electroencephalogram and Electromyography
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Jul 2023to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two groups of participants, who age 40 or older, will be involved in this study. Each group will have from 10 to 30 participants. The first group will include a group of individuals without Parkinson's disease and the second group will include people with Parkinson's disease, both will be screened for eligibility. Participants who meet the inclusion criteria will go through the planned assessment procedure.
Who may be able to join
- People ≥ 40 years old.
- Participants diagnosed with Parkinson's disease by a neurologist, regardless the type.
- Modified Hoehn and Yahr stages I to III.
- Able to follow instructions and understand questions.
- Able to walk independently and without walking aids.
- People who experience excessive fear of falling and fear of movement.
- Able to communicate verbally.
- Stable use of Parkinson's Disease or other comorbidities medications.
Who cannot join
- Impaired vision and hearing.
- Unstable medical condition.
- Co-existing neurological or orthopedic conditions that may limit mobility and affect participation.
- Dizziness, vertigo, headache, and motion-sickness.
- Cognition impairments.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Human Mechatronics Lab, Ain Shams Virtual Hospital, Ain Shams University
Cairo, 11535
Mohamed I Awad, Ph.d, +201123222146, Mohammed.awad@eng.asu.edu.eg
About this study
Official title: The Role of Virtual Reality in Examining the Effect of Fear of Falling (FOF) on Postural Stability in Individuals Without and With Parkinson's Disease in Egypt: A Mixed Methods Feasibility Study
Background: Falls are common in elderly individuals and those with neurological conditions like Parkinson's disease. Parkinson's disease causes postural instability and mobility issues that lead to falls and reduced quality of life. The fear of falling (FoF), a natural response to unstable balance, can exacerbate postural control problems. However, evaluating FoF relies primarily on subjective self-reports due to a lack of objective assessment methods.
Objectives: This mixed-methods feasibility study aims to develop an objective method for assessing fear of falling during motion and walking using virtual reality. This protocol examines a range of FoF-related responses, including cognitive, neuromuscular, and postural stability factors.
Read more
Methods: Individuals without and with Parkinson's disease will complete questionnaires, movement tasks, and walking assessments in real and virtual environments where FoF can be elicited using virtual reality (VR) technology. Data from center-of-pressure measurements, electromyography, heart rate monitoring, motion capture, and usability metrics will evaluate the method's acceptability and safety. Semi-structured interviews will gather participants' and researchers' experiences of the protocol.
Discussion: This method may allow accurate assessment of how FoF impacts movement by measuring cognitive, neuromuscular, and postural responses during gait and motion. Virtual environments reproduce real-life scenarios that trigger FoF. Rigorously assessing FoF with this approach could demonstrate its ability to quantify the effects of FoF on movement.
Conclusions: This protocol aims to improve FoF assessment by evaluating multiple responses during movement in virtual environments. It addresses current measures' limitations. A feasibility study will identify areas for improvement specific to Parkinson's disease. Successful validation could transform how FoF is evaluated and managed.
- Being tested
- Virtual reality, Electroencephalogram, Electromyography, Motion Capture system, Polar H10 Heart Sensor
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDiagnostic test
Virtual environment that triggers fear of falling
ElectroencephalogramDiagnostic test
Detect brain waves in response to fear of falling
ElectromyographyDiagnostic test
Measures muscle activity and response to fear of falling
Motion Capture systemDiagnostic test
Measures postural and gait responses to fear of falling
Polar H10 Heart SensorDiagnostic test
Heart rate monitor
Inertial measurement UniteDiagnostic test
Measure Postural sway
| Study group | Role | What they receive |
|---|---|---|
| Individuals without Parkinson's disease | People over 40 years old Receives: Diagnostic Test: Virtual reality; Diagnostic Test: Electroencephalogram; Diagnostic Test: Electromyography; Diagnostic Test: Motion Capture system; Diagnostic Test: Polar H10 Heart Sensor; Diagnostic Test: Inertial measurement Unite | |
| Parkinson Disease | People over 40 years old who have Parkinson's Disease at stage I to III Hoehn and Yahr scale Receives: Diagnostic Test: Virtual reality; Diagnostic Test: Electroencephalogram; Diagnostic Test: Electromyography; Diagnostic Test: Motion Capture system; Diagnostic Test: Polar H10 Heart Sensor; Diagnostic Test: Inertial measurement Unite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Control
Movement control throughout the movement scenario will be assessed using a Qualisys motion capture system (MCS).
Measured: 5 minutes
Balance Assessment
Force platforms will measure the center of pressure (COP) displacement during the movement scenario.
Measured: 5 minutes
Postural Sway
A postural Inertial Measurement Unit (IMU) will be placed over the projected center of mass located at the 4th lumbar vertebra to evaluate postural sway.
Measured: 5 minutes
EEG Monitoring
The electroencephalogram (EEG) will be used to monitor the neuromuscular system's reaction to fear throughout the movement scenario. power in alpha and beta frequency bands will be recorded.
Measured: 5 minutes
EMG Monitoring
The electromyography (EMG) will be employed to monitor the neuromuscular system's reaction to fear throughout the movement scenario. Muscle activation of lower limb muscles such as tibialis anterior and quadriceps will be recorded by surface EMG.
Measured: 5 minutes
Heart Rate Monitoring
The unit of measurement for heart rate monitoring is typically beats per minute (BPM). The Polar H10 heart rate sensor will be used in to measure the electrical signals produced by the heart and provides continuous and accurate heart rate readings in BPM.
Measured: 5 minutes
Suitability Evaluation
the Suitability Evaluation Questionnaire (SEQ) is the SEQ Suitability Evaluation Questionnaire for Virtual Rehabilitation Systems. The range of scores is 0 to 100, with higher scores indicating a better outcome. The SEQ is scored by summing the responses to the 14 items. The items are scored on a 7-point Likert scale, with 1 = strongly disagree and 7 = strongly agree. The total score can range from 0 to 98. A higher score on the SEQ indicates that the VR system is perceived as being more user-friendly, enjoyable, and safe. This suggests that the patient is more likely to use the VR system and to benefit from it.
Measured: 30 minutes
Sense of Presence
The iGroup Presence Questionnaire (IPQ) has a range of scores is 0 to 6, with higher scores indicating a better outcome. The IPQ is scored by summing the responses to the 14 items. The items are scored on a 7-point Likert scale, with 1 = disagree strongly and 7 = agree strongly. The total score can range from 0 to 98. A higher score on the IPQ indicates that the user feels more present in the Virtual environment (VE). This suggests that the VE is more immersive and engaging, and that the user is more likely to be absorbed in the experience.
Measured: 30 minutes
Effort
The Borg Rated Perceived Exertion (RPE) scale will record effort during the session. The Borg Rated Perceived Exertion (RPE) Scale: Range 0-10, higher scores indicate greater perceived exertion.
Measured: 30 minutes
Adverse events
any adverse events during the procedure and after effects will be documented. Number of participants reporting adverse events as per study protocol
Measured: 30 minutes
Secondary outcomes (8)
Fear of Falling Assessment
Fear of falling will be assessed using the Falls Efficacy Scale International (FES-I).
Measured: 45 minutes
Cognition Assessment
Montreal Cognitive Assessment (MoCA) is a brief, 30-item cognitive screening test that is used to assess a person's cognitive abilities. Montreal Cognitive Assessment has a minimum value of 0 and maximum value of 3 with Higher score indicates better outcome. A score of 26 or higher is considered normal, while a score of 25 or lower may indicate cognitive impairment.
Measured: 45 minutes
Depression Assessment
Hamilton Depression Rating Scale (HAM-D) will be used to assess depression level. Minimum value is 0 and the maximum value is 52. Lower scores indicate better outcome. The HAM-D is a 17-item clinician-rated scale that is used to assess the severity of depression. The scale was developed by Max Hamilton in 1960 and has been used in a wide range of studies to assess depression. The HAM-D covers a range of symptoms of depression, including depressed mood, feelings of guilt, suicidal ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. Each item is scored on a 5-point scale, with 0 = absent and 4 = severe. The total score can range from 0 to 52, with a higher score indicating more severe depression.
Measured: 45 minutes
Anxiety Assessment
Hamilton Anxiety Rating Scale will be used to assess level of anxiety. the Minimum value is 0 and Maximum value is 56. Lower score indicates better outcome. It is a 14-item clinician-rated scale that is used to assess the severity of anxiety. The scale was developed by Max Hamilton in 1959 and has been used in a wide range of studies to assess anxiety. It covers a range of symptoms of anxiety, including anxious mood, tension, fears, insomnia, intellectual, somatic (muscular), somatic (sensory), cardiovascular, respiratory, gastrointestinal, genitourinary, autonomic symptoms, and behavior at interview. Each item is scored on a 4-point scale, with 0 = absent and 4 = severe. The total score can range from 0 to 56, with a higher score indicating more severe anxiety.
Measured: 45 minutes
Participation Assessment
Participation levels will be assessed using the World Health Organization Disability Assessment Schedule 2.0. the Minimum value is 0 and Maximum value is 100. Lower score indicates better outcome. The WHODAS 2.0 is a 12-item self-report questionnaire that is used to assess the impact of a health condition on an individual's functioning. The items are scored on a 5-point scale, with 0 = no difficulty and 4 = extreme difficulty. The total score can range from 0 to 100, with a lower score indicating less disability. The WHODAS 2.0 covers six domains of functioning: cognition, mobility, self-care, getting along, life activities, and participation. The scale was developed by the World Health Organization (WHO) and is based on the International Classification of Functioning, Disability and Health (ICF).
Measured: 45 minutes
Health-related Quality of Life Assessment
Health-related quality of life will be evaluated using the Parkinson's Disease Questionnaire 39 (PDQ-39). Parkinson's Disease Questionnaire 39 has a Minimum value of 0 and Maximum value of 100. Lower score indicates better outcome. The PDQ-39 is a 39-item self-report questionnaire that is used to assess the impact of Parkinson's disease (PD) on an individual's quality of life. The items are scored on a 5-point scale, with 0 = no problem and 4 = severe problem. The total score can range from 0 to 100, with a lower score indicating better quality of life.
Measured: 45 minutes
Balance confidence
Balance confidence will be evaluated using Activity-specific Balance Confidence scale (ABC scale). Which is a self-administered scale to indicate the level of confidence the person has in doing the activity without losing his/her balance. The ABC is an 16 point scale and ratings should consist of whole numbers (0 to 100) for each item. Total the ratings and divide by 16 to get each subject's ABC score.
Measured: 10 minutes
Combined Balance assessment
Mini Balance Evaluation System Test (mini-BESTest) will be used and it assesses 4 domains: Anticipatory postural adjustments, Reactive postural control, Sensory orientation, and Dynamic gait. The test has a maximum score of 28 points from 14 items that are each scored from 0-2. "0" indicates the lowest level of function and "2" the highest level of function.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start17 Jul 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ParkinsonStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, Yasmine Gomaa, Ahram Canadian University
- Investigators
- Yasmine S Gomaa, Ph.d, Principal investigator, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931692
- Sponsor's protocol ID
- P.T/ NEUR /3/2023/46
- Status last verified
- Apr 2024
- First submitted
- 15 Jun 2023
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gomaa YS, Awad MI, Emara T, Elbokl A, Al-Yahya E, ElMeligie MM. Role of virtual reality in examining the effect of fear of falling (FOF) on postural stability in individuals without and with Parkinson's disease in Egypt: a mixed-methods feasibility study protocol. BMJ Open. 2024 May 1;14(5):e080592. doi: 10.1136/bmjopen-2023-080592.
PubMed 38692713
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Virtual Reality in Examining the Effect of Fear of Falling (FOF) on Postural Stability in Individuals Without and With Parkinson's Disease in Egypt: A Mixed Methods Feasibility Study
- ClinicalTrials.gov ID
- NCT05931692
- Acronym / sponsor ID
- P.T/ NEUR /3/2023/46
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 5 Jul 2023 (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.
Background: Falls are common in elderly individuals and those with neurological conditions like Parkinson's disease. Parkinson's disease causes postural instability and mobility issues that lead to falls and reduced quality of life. The fear of falling (FoF), a natural response to unstable balance, can exacerbate postural control problems. However, evaluating FoF relies primarily on subjective self-reports due to a lack of objective assessment methods.
Objectives: This mixed-methods feasibility study aims to develop an objective method for assessing fear of falling during motion and walking using virtual reality. This protocol examines a range of FoF-related responses, including cognitive, neuromuscular, and postural stability factors.
Methods: Individuals without and with Parkinson's disease will complete questionnaires, movement tasks, and walking assessments in real and virtual environments where FoF can be elicited using virtual reality (VR) technology. Data from center-of-pressure measurements, electromyography, heart rate monitoring, motion capture, and usability metrics will evaluate the method's acceptability and safety. Semi-structured interviews will gather participants' and researchers' experiences of the protocol.
Discussion: This method may allow accurate assessment of how FoF impacts movement by measuring cognitive, neuromuscular, and postural responses during gait and motion. Virtual environments reproduce real-life scenarios that trigger FoF. Rigorously assessing FoF with this approach could demonstrate its ability to quantify the effects of FoF on movement.
Conclusions: This protocol aims to improve FoF assessment by evaluating multiple responses during movement in virtual environments. It addresses current measures' limitations. A feasibility study will identify areas for improvement specific to Parkinson's disease. Successful validation could transform how FoF is evaluated and managed.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individuals without Parkinson's disease | – | Diagnostic Test: Virtual reality, Diagnostic Test: Electroencephalogram, Diagnostic Test: Electromyography, Diagnostic Test: Motion Capture system, Diagnostic Test: Polar H10 Heart Sensor, Diagnostic Test: Inertial measurement UnitePeople over 40 years old |
| Parkinson Disease | – | Diagnostic Test: Virtual reality, Diagnostic Test: Electroencephalogram, Diagnostic Test: Electromyography, Diagnostic Test: Motion Capture system, Diagnostic Test: Polar H10 Heart Sensor, Diagnostic Test: Inertial measurement UnitePeople over 40 years old who have Parkinson's Disease at stage I to III Hoehn and Yahr scale |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two groups of participants, who age 40 or older, will be involved in this study. Each group will have from 10 to 30 participants. The first group will include a group of individuals without Parkinson's disease and the second group will include people with Parkinson's disease, both will be screened for eligibility. Participants who meet the inclusion criteria will go through the planned assessment procedure.
Key inclusion criteria (8 listed)
- People ≥ 40 years old.
- Participants diagnosed with Parkinson's disease by a neurologist, regardless the type.
- Modified Hoehn and Yahr stages I to III.
- Able to follow instructions and understand questions.
- Able to walk independently and without walking aids.
Key exclusion criteria (6 listed)
- Impaired vision and hearing.
- Unstable medical condition.
- Co-existing neurological or orthopedic conditions that may limit mobility and affect participation.
- Dizziness, vertigo, headache, and motion-sickness.
- Cognition impairments.
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 |
|---|---|---|
| Virtual realityVirtual environment that triggers fear of falling | Diagnostic test | Individuals without Parkinson's disease, Parkinson Disease |
| ElectroencephalogramDetect brain waves in response to fear of falling | Diagnostic test | Individuals without Parkinson's disease, Parkinson Disease |
| ElectromyographyMeasures muscle activity and response to fear of falling | Diagnostic test | Individuals without Parkinson's disease, Parkinson Disease |
| Motion Capture systemMeasures postural and gait responses to fear of falling | Diagnostic test | Individuals without Parkinson's disease, Parkinson Disease |
| Polar H10 Heart SensorHeart rate monitor | Diagnostic test | Individuals without Parkinson's disease, Parkinson Disease |
| Inertial measurement UniteMeasure Postural sway | Diagnostic test | Individuals without Parkinson's disease, Parkinson Disease |
Primary outcome
Movement Control
Time frame: 5 minutes
Movement control throughout the movement scenario will be assessed using a Qualisys motion capture system (MCS).
Balance Assessment
Time frame: 5 minutes
Force platforms will measure the center of pressure (COP) displacement during the movement scenario.
Postural Sway
Time frame: 5 minutes
A postural Inertial Measurement Unit (IMU) will be placed over the projected center of mass located at the 4th lumbar vertebra to evaluate postural sway.
EEG Monitoring
Time frame: 5 minutes
The electroencephalogram (EEG) will be used to monitor the neuromuscular system's reaction to fear throughout the movement scenario. power in alpha and beta frequency bands will be recorded.
EMG Monitoring
Time frame: 5 minutes
The electromyography (EMG) will be employed to monitor the neuromuscular system's reaction to fear throughout the movement scenario. Muscle activation of lower limb muscles such as tibialis anterior and quadriceps will be recorded by surface EMG.
Heart Rate Monitoring
Time frame: 5 minutes
The unit of measurement for heart rate monitoring is typically beats per minute (BPM). The Polar H10 heart rate sensor will be used in to measure the electrical signals produced by the heart and provides continuous and accurate heart rate readings in BPM.
Suitability Evaluation
Time frame: 30 minutes
the Suitability Evaluation Questionnaire (SEQ) is the SEQ Suitability Evaluation Questionnaire for Virtual Rehabilitation Systems. The range of scores is 0 to 100, with higher scores indicating a better outcome. The SEQ is scored by summing the responses to the 14 items. The items are scored on a 7-point Likert scale, with 1 = strongly disagree and 7 = strongly agree. The total score can range from 0 to 98. A higher score on the SEQ indicates that the VR system is perceived as being more user-friendly, enjoyable, and safe. This suggests that the patient is more likely to use the VR system and to benefit from it.
Sense of Presence
Time frame: 30 minutes
The iGroup Presence Questionnaire (IPQ) has a range of scores is 0 to 6, with higher scores indicating a better outcome. The IPQ is scored by summing the responses to the 14 items. The items are scored on a 7-point Likert scale, with 1 = disagree strongly and 7 = agree strongly. The total score can range from 0 to 98. A higher score on the IPQ indicates that the user feels more present in the Virtual environment (VE). This suggests that the VE is more immersive and engaging, and that the user is more likely to be absorbed in the experience.
Effort
Time frame: 30 minutes
The Borg Rated Perceived Exertion (RPE) scale will record effort during the session. The Borg Rated Perceived Exertion (RPE) Scale: Range 0-10, higher scores indicate greater perceived exertion.
Adverse events
Time frame: 30 minutes
any adverse events during the procedure and after effects will be documented. Number of participants reporting adverse events as per study protocol
8 secondary outcomes
Fear of Falling Assessment
Time frame: 45 minutes
Cognition Assessment
Time frame: 45 minutes
Depression Assessment
Time frame: 45 minutes
Anxiety Assessment
Time frame: 45 minutes
Participation Assessment
Time frame: 45 minutes
Health-related Quality of Life Assessment
Time frame: 45 minutes
Balance confidence
Time frame: 10 minutes
Combined Balance assessment
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Derived from this study: PubMed 38692713Gomaa YS, Awad MI, Emara T, Elbokl A, Al-Yahya E, ElMeligie MM. Role of virtual reality in examining the effect of fear of falling (FOF) on postural stability in individuals without and with Parkinson's disease in Egypt: a mixed-methods feasibility study protocol. BMJ Open. 2024 May 1;14(5):e080592. doi: 10.1136/bmjopen-2023-080592.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yasmine S Gomaa, Ph.d principal investigator
Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson and Parkinson Disease, run by Ahram Canadian University at 1 site in Egypt.
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 8 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: status not confirmed, as of the sponsor's last update on 26 Apr 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasmine S Gomaa, Ph.d (+201001590520, yasmeen_gomaa@pt.kfs.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Control (time frame: 5 minutes). The study lists 10 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 NCT05931692, which also lists 1 linked publication.
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 26 Apr 2024.