Occupational TherapyGRASPNCT03872466
Glove Rehabilitation Application for Stroke Patients
A study testing GRASP HEP in people with Occupational Therapy and Virtual Reality, run by Barron Associates, Inc. at 1 site in United States.
Trial summary
The University of Virginia (UVA) Director of Neurorehabilitation will lead GRASP randomized, controlled efficacy trials. The study will involve employment of the GRASP system in three one-hour sessions per week over eight weeks by stroke survivors suffering from ongoing hand function impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Occupational Therapy, Virtual Reality
- What is being tested?
- GRASP HEP
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2020to 26 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participant has had a right or left hemispheric stroke affecting normal hand function;
- Participant has sufficient active finger flexion at the MCP joint in at least one finger to be detected by visual observation by a study therapist;
- Participant has visual acuity with corrective lenses of 20/50 or better;
- Participant's affected hand fits within sizing available for the glove orthosis;
- Participant is no longer in an active UE rehabilitation program; and
- Participant is currently living at a private residence and anticipates remaining at that location for the duration of study participation.
Who cannot join
- Withholding or withdrawal of consent by the participant;
- Inability to understand and follow verbal directions;
- Determination by the Principal Investigator that participation would result in overexertion or significant discomfort or pain;
- A psychological diagnosis that in the determination of the Principal Investigator could significantly impact subject's participation or that could be aggravated by study participation (Principal Investigator will consult with candidate's personal physician as appropriate); (4) Determination by the Principal Investigator that participation would result in significant agitation or elevated stress; (5) Visual field deficit in either eye that impairs the ability to view the computer monitor; (6) Stiffness or contractures of the muscles, joints, tendons, ligaments, or skin that restricts normal movement; (7) More than mild tone/spasticity (measured on modified Ashworth, 5-point scale); (8) Severe contractures or joint deformities in the fingers; (9) Open wound or infection, severe edema, or excessive swelling which might interfere with wearing the glove; (10) Severe pre-stroke co-morbidities, such as cardiovascular, neurological, orthopedic, or rheumatoid impairments before stroke that may interfere with task performance; (11) Severe sensory deficits from the involved UE; or (12) Hemispatial neglect that impairs the ability to process and perceive visual stimuli provided through the computer monitor.
Trial locations and contacts
1 site in 1 country.
United States1 site
UVA Outpatient Rehabilitation Clinic
Charlottesville, Virginia, 22901
About this study
Official title: Glove Rehabilitation Application for Stroke Patients (GRASP)
The University of Virginia (UVA) Director of Neurorehabilitation will lead GRASP randomized, controlled efficacy trials. The study will involve employment of the GRASP system in three one-hour sessions per week over eight weeks by stroke survivors suffering from ongoing hand function impairment.
Read the detailed description
Testing will involve employment of the GRASP system (glove orthosis, sensor package, and application software) in three one-hour sessions per week over eight weeks by stroke survivors suffering from ongoing hand function impairment. This frequency and duration is consistent with previous studies successfully investigating new upper extremity (UE) therapies. The primary outcome of the efficacy study will be change in hand function for a group of participants using the GRASP system versus a control group receiving standard care over the same period.
Participants assigned to the GRASP intervention group will attend five outpatient clinic visits for consent, pre-assessment, and familiarization with the system, followed by an initial home visit and eight weeks (3x per week) of independent at-home practice. In this study period, GRASP intervention group participants will employ the instrumented glove orthosis while performing functional tasks within virtual activities of daily living (ADLs).
Participants in the Usual Care Treatment (UCT) control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT control group participants.
- Conditions
- Occupational Therapy, Virtual Reality
- Being tested
- GRASP HEP, Usual Care Treatment (UCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRASP HEPDevice
The GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand.
Usual Care Treatment (UCT)Behavioural
Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants.
| Study group | Role | What they receive |
|---|---|---|
| GRASP Intervention | Experimental | This arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system. Receives: Device: GRASP HEP |
| Control | Active comparator | Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants. Receives: Behavioral: Usual Care Treatment (UCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE)
FMUE is one of the most widely used and accepted quantitative measures of motor function in stroke patients, used in clinical and research settings. Individual patient movements associated with specific motor functions are scored using a 3-point ordinal scale (0, 1, or 2). The study employs a subscale of the full assessment that incorporates 33 items relevant to shoulder, elbow, forearm, wrist, hand, and grasp function, thus creating a possible range of 0 to 66 points. Higher scores correspond to higher levels of motor function.
Measured: Pre-intervention at Baseline
Post Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE)
FMUE is one of the most widely used and accepted quantitative measures of motor function in stroke patients, used in clinical and research settings. Individual patient movements associated with specific motor functions are scored using a 3-point ordinal scale (0, 1, or 2). The study employs a subscale of the full assessment that incorporates 33 items relevant to shoulder, elbow, forearm, wrist, hand, and grasp function, thus creating a possible range of 0 to 66 points. Higher scores correspond to higher levels of motor function.
Measured: Post Intervention at 8 weeks
Secondary outcomes (10)
Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)
The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement.
The WMFT Functional Assessment (WMFT-FA) score is an observational assessment of movement quality and scored using a 6-point ordinal rating scale that ranges from 0 (no use of the affected side attempted) to 5 (normal function). A total WMFT-FA score is calculated by taking the average across all 15 UE tasks. A patient's WMFT-FA score is thus a real number that can range from 0 to 5. An increase in WMFT-FA score implies improved motor function.
Measured: Pre-intervention at Baseline
Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)
The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement.
The WMFT Functional Assessment (WMFT-FA) score is an observational assessment of movement quality and scored using a 6-point ordinal rating scale that ranges from 0 (no use of the affected side attempted) to 5 (normal function). A total WMFT-FA score is calculated by taking the average across all 15 UE tasks. A patient's WMFT-FA score is thus a real number that can range from 0 to 5. An increase in WMFT-FA score implies improved motor function.
Measured: Post Intervention at 8 weeks
Pre Intervention Wolf Motor Function Test Time (WMFT-TIME)
The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. WMFT-TIME is a quantitative measure calculated using the average time to complete the tasks. Any time greater than 120 seconds is recorded as 120 seconds. A patient's WMFT-TIME score (average completion time) thus ranges from 0 to 120. A reduction in WMFT-TIME implies improved motor function.
Measured: Pre-intervention at Baseline
Post Intervention Wolf Motor Function Test Time (WMFT-TIME)
The WMFT test is a functionally-oriented clinical and research instrument. The test consists of 15 motor tasks scored both for time and quality of movement. WMFT-TIME is a quantitative measure calculated using the average time to complete the tasks. Any time greater than 120 seconds is recorded as 120 seconds. A patient's WMFT-TIME score (average completion time) thus ranges from 0 to 120. A reduction in WMFT-TIME implies improved motor function.
Measured: Post Intervention at 8 weeks
Pre Intervention Box and Blocks Test (BBT)
The BBT provides a measure of unilateral gross manual dexterity. Subjects are asked to move 2.5 cm wooden cubes from one 8.5 cm tall box to another, as quickly as possible. The BBT score is simply the number of blocks moved in 60 seconds. A patient's WMFT-FA score is thus an integer number if blocks that is greater than or equal to zero. The maximum number of blocks is 150. An increase in BBT score implies improved motor function.
Measured: Pre-intervention at Baseline
Post Intervention Box and Blocks Test (BBT)
The BBT provides a measure of unilateral gross manual dexterity. Subjects are asked to move 2.5 cm wooden cubes from one 8.5 cm tall box to another, as quickly as possible. The BBT score is simply the number of blocks moved in 60 seconds. A patient's WMFT-FA score is thus an integer number if blocks that is greater than or equal to zero. The maximum number of blocks is 150. An increase in BBT score implies improved motor function.
Measured: Post Intervention at 8 weeks
Pre Intervention Motor Activity Log - Amount (MAL-Amount)
The MAL is a structured interview assessing use of the affected arm in 30 daily activities in the subject's real-life experience. These range from turning on a light to eating finger foods. For each activity, the subject provides a self-assessment of the frequency with which the affected arm is involved in the activity (MAL-Amount) and the quality with which the affected arm performs (MAL-How Well). Grading is on a Likert scale. At the low end, 0 corresponds to never using the weaker arm for the activity. On the upper end, 5 corresponds to using the weaker arm equivalently to the stronger arm. A total MAL-Amount score is calculated by taking the average across all 30 activities. Likewise, a total MAL-How Well score is calculated by taking the average across all 30 activities. A patient's MAL-Amount and MAL-How Well scores are thus real numbers that can range from 0 to 5. An increase in these scores implies improved motor function.
Measured: Pre-intervention at Baseline
Post Intervention Motor Activity Log - Amount (MAL-Amount)
The MAL is a structured interview assessing use of the affected arm in 30 daily activities in the subject's real-life experience. These range from turning on a light to eating finger foods. For each activity, the subject provides a self-assessment of the frequency with which the affected arm is involved in the activity (MAL-Amount) and the quality with which the affected arm performs (MAL-How Well). Grading is on a Likert scale. At the low end, 0 corresponds to never using the weaker arm for the activity. On the upper end, 5 corresponds to using the weaker arm equivalently to the stronger arm. A total MAL-Amount score is calculated by taking the average across all 30 activities. Likewise, a total MAL-How Well score is calculated by taking the average across all 30 activities. A patient's MAL-Amount and MAL-How Well scores are thus real numbers that can range from 0 to 5. An increase in these scores implies improved motor function.
Measured: Post Intervention at 8 weeks
Pre Intervention Motor Activity Log - How Well (MAL-How Well)
The MAL is a structured interview assessing use of the affected arm in 30 daily activities in the subject's real-life experience. These range from turning on a light to eating finger foods. For each activity, the subject provides a self-assessment of the frequency with which the affected arm is involved in the activity (MAL-Amount) and the quality with which the affected arm performs (MAL-How Well). Grading is on a Likert scale. At the low end, 0 corresponds to never using the weaker arm for the activity. On the upper end, 5 corresponds to using the weaker arm equivalently to the stronger arm. A total MAL-Amount score is calculated by taking the average across all 30 activities. Likewise, a total MAL-How Well score is calculated by taking the average across all 30 activities. A patient's MAL-Amount and MAL-How Well scores are thus real numbers that can range from 0 to 5. An increase in these scores implies improved motor function.
Measured: Pre-intervention at Baseline
Post Intervention Motor Activity Log - How Well (MAL-How Well)
The MAL is a structured interview assessing use of the affected arm in 30 daily activities in the subject's real-life experience. These range from turning on a light to eating finger foods. For each activity, the subject provides a self-assessment of the frequency with which the affected arm is involved in the activity (MAL-Amount) and the quality with which the affected arm performs (MAL-How Well). Grading is on a Likert scale. At the low end, 0 corresponds to never using the weaker arm for the activity. On the upper end, 5 corresponds to using the weaker arm equivalently to the stronger arm. A total MAL-Amount score is calculated by taking the average across all 30 activities. Likewise, a total MAL-How Well score is calculated by taking the average across all 30 activities. A patient's MAL-Amount and MAL-How Well scores are thus real numbers that can range from 0 to 5. An increase in these scores implies improved motor function.
Measured: Post Intervention at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start11 Jun 2020
- Primary completion26 Apr 2022
- Study completion26 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Occupational TherapyStudies 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
- Model description
- Intervention group performs therapy using the GRASP system for virtual world-based practice. Control group follows a Usual Care Treatment (UCT) regimen.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barron Associates, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Virginia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872466
- Sponsor's protocol ID
- GRASP
- Acronym
- GRASP
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2019
- Last updated
- 25 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Adams RJ, Ellington AL, Kuccera KA, Leaman H, Smithson C, Patrie JT. Telehealth-Guided Virtual Reality for Recovery of Upper Extremity Function Following Stroke. OTJR (Thorofare N J). 2023 Jul;43(3):446-456. doi: 10.1177/15394492231158375. Epub 2023 Mar 24.
PubMed 36960762
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glove Rehabilitation Application for Stroke Patients (GRASP)
- ClinicalTrials.gov ID
- NCT03872466
- Acronym / sponsor ID
- GRASP / GRASP
- Conditions
- Occupational Therapy, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Barron Associates, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Virginia
- Study start
- 11 Jun 2020 (actual)
- Primary completion
- 26 Apr 2022 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Posted 25 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The University of Virginia (UVA) Director of Neurorehabilitation will lead GRASP randomized, controlled efficacy trials. The study will involve employment of the GRASP system in three one-hour sessions per week over eight weeks by stroke survivors suffering from ongoing hand function impairment.
Detailed description
Testing will involve employment of the GRASP system (glove orthosis, sensor package, and application software) in three one-hour sessions per week over eight weeks by stroke survivors suffering from ongoing hand function impairment. This frequency and duration is consistent with previous studies successfully investigating new upper extremity (UE) therapies. The primary outcome of the efficacy study will be change in hand function for a group of participants using the GRASP system versus a control group receiving standard care over the same period.
Participants assigned to the GRASP intervention group will attend five outpatient clinic visits for consent, pre-assessment, and familiarization with the system, followed by an initial home visit and eight weeks (3x per week) of independent at-home practice. In this study period, GRASP intervention group participants will employ the instrumented glove orthosis while performing functional tasks within virtual activities of daily living (ADLs).
Participants in the Usual Care Treatment (UCT) control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT control group participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Intervention group performs therapy using the GRASP system for virtual world-based practice. Control group follows a Usual Care Treatment (UCT) regimen.
| Arm | Type | Receives |
|---|---|---|
| GRASP Intervention | Experimental | Device: GRASP HEPThis arm will perform eight weeks of independent home practice for upper extremity therapy using the GRASP system. |
| Control | Active comparator | Behavioral: Usual Care Treatment (UCT)Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as control group participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant has had a right or left hemispheric stroke affecting normal hand function;
- Participant has sufficient active finger flexion at the MCP joint in at least one finger to be detected by visual observation by a study therapist;
- Participant has visual acuity with corrective lenses of 20/50 or better;
- Participant's affected hand fits within sizing available for the glove orthosis;
- Participant is no longer in an active UE rehabilitation program; and
Key exclusion criteria (4 listed)
- Withholding or withdrawal of consent by the participant;
- Inability to understand and follow verbal directions;
- Determination by the Principal Investigator that participation would result in overexertion or significant discomfort or pain;
- A psychological diagnosis that in the determination of the Principal Investigator could significantly impact subject's participation or that could be aggravated by study participation (Principal Investigator will consult with candidate's personal physician as appropriate); (4) Determination by the Principal Investigator that participation would result in significant agitation or elevated stress; (5) Visual field deficit in either eye that impairs the ability to view the computer monitor; (6) Stiffness or contractures of the muscles, joints, tendons, ligaments, or skin that restricts normal movement; (7) More than mild tone/spasticity (measured on modified Ashworth, 5-point scale); (8) Severe contractures or joint deformities in the fingers; (9) Open wound or infection, severe edema, or excessive swelling which might interfere with wearing the glove; (10) Severe pre-stroke co-morbidities, such as cardiovascular, neurological, orthopedic, or rheumatoid impairments before stroke that may interfere with task performance; (11) Severe sensory deficits from the involved UE; or (12) Hemispatial neglect that impairs the ability to process and perceive visual stimuli provided through the computer monitor.
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 |
|---|---|---|
| GRASP HEPThe GRASP system comprises a sensor package and therapy game software that works with a commercial glove orthosis to enable virtual world-based practice of activities of daily living (ADLs) involving the hand. | Device | GRASP Intervention |
| Usual Care Treatment (UCT)Participants in the control group will continue to receive any previously prescribed therapy services. These patients will not receive any treatment services through the study as UCT group participants. | Behavioural | Control |
Primary outcome
Pre Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE)
Time frame: Pre-intervention at Baseline
FMUE is one of the most widely used and accepted quantitative measures of motor function in stroke patients, used in clinical and research settings. Individual patient movements associated with specific motor functions are scored using a 3-point ordinal scale (0, 1, or 2). The study employs a subscale of the full assessment that incorporates 33 items relevant to shoulder, elbow, forearm, wrist, hand, and grasp function, thus creating a possible range of 0 to 66 points. Higher scores correspond to higher levels of motor function.
Post Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE)
Time frame: Post Intervention at 8 weeks
FMUE is one of the most widely used and accepted quantitative measures of motor function in stroke patients, used in clinical and research settings. Individual patient movements associated with specific motor functions are scored using a 3-point ordinal scale (0, 1, or 2). The study employs a subscale of the full assessment that incorporates 33 items relevant to shoulder, elbow, forearm, wrist, hand, and grasp function, thus creating a possible range of 0 to 66 points. Higher scores correspond to higher levels of motor function.
10 secondary outcomes
Pre Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)
Time frame: Pre-intervention at Baseline
Post Intervention Wolf Motor Function Test Functional Assessment (WMFT-FA)
Time frame: Post Intervention at 8 weeks
Pre Intervention Wolf Motor Function Test Time (WMFT-TIME)
Time frame: Pre-intervention at Baseline
Post Intervention Wolf Motor Function Test Time (WMFT-TIME)
Time frame: Post Intervention at 8 weeks
Pre Intervention Box and Blocks Test (BBT)
Time frame: Pre-intervention at Baseline
Post Intervention Box and Blocks Test (BBT)
Time frame: Post Intervention at 8 weeks
Pre Intervention Motor Activity Log - Amount (MAL-Amount)
Time frame: Pre-intervention at Baseline
Post Intervention Motor Activity Log - Amount (MAL-Amount)
Time frame: Post Intervention at 8 weeks
Pre Intervention Motor Activity Log - How Well (MAL-How Well)
Time frame: Pre-intervention at Baseline
Post Intervention Motor Activity Log - How Well (MAL-How Well)
Time frame: Post Intervention at 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36960762Adams RJ, Ellington AL, Kuccera KA, Leaman H, Smithson C, Patrie JT. Telehealth-Guided Virtual Reality for Recovery of Upper Extremity Function Following Stroke. OTJR (Thorofare N J). 2023 Jul;43(3):446-456. doi: 10.1177/15394492231158375. Epub 2023 Mar 24.
- 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.
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 GRASP HEP in people with Occupational Therapy and Virtual Reality, run by Barron Associates, Inc. at 1 site in United States.
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 6 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: finished, as of the sponsor's last update on 25 Mar 2025. 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 United States. 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?
Yes. Results are posted in the registry (first posted 25 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pre Intervention Fugl-Meyer Assessment of Upper Extremity Motor Function (FMUE) (time frame: Pre-intervention at Baseline). The study lists 2 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 NCT03872466, 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 25 Mar 2025.