StrokeNCT07308054
The Effects of Fresnel Prism Glasses on Visual Perception, Balance, Gait and Functional Independence in Post-Stroke Patients
A study testing Fresnel Prism Glasse and Convetional physical therapy in people with Stroke, run by Lahore University of Biological and Applied Sciences.
Trial summary
This randomized controlled trial aims to evaluate the effects of Fresnel prism glasses on visual perception, balance, gait, and functional independence in post-stroke patients. Stroke survivors, particularly those with right hemisphere involvement, often experience visuospatial deficits such as unilateral spatial… Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Fresnel Prism Glasse and Convetional physical therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 13 Dec 2025to 26 May 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 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria Right hemisphere with left side neglect (14). Adults (40-65 years old) who have experienced an ischemic stroke for the first time (1-3 months post-stroke) are eligible (15) A score of 2-4 in the Functional Ambulation Category (FAC) (16) and MMSE ≥24 (to guarantee training-related cognitive ability)(17). Patient who can walk more than 10m Independently Exclusion Criteria Severe comorbidities, such as neurological or orthopedic disorders and impair gait(18) Hearing and vision problems that are not assisted. Patients with profound sensory impairment or significant cognitive dysfunction(19) Individuals who have recently suffered from cardiac failure, myocardial infarction, or other severe illnesses(20)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This randomized controlled trial aims to evaluate the effects of Fresnel prism glasses on visual perception, balance, gait, and functional independence in post-stroke patients. Stroke survivors, particularly those with right hemisphere involvement, often experience visuospatial deficits such as unilateral spatial neglect, leading to impaired balance, abnormal gait, and reduced functional independence. Fresnel prism glasses offer a low-cost, non-invasive intervention that may improve visuospatial alignment and postural control by modifying visual input. Adult post-stroke patients will be randomly allocated into an intervention group receiving Fresnel prism glasses alongside conventional physical therapy, and a control group receiving conventional therapy alone. Outcome measures will include the Motor-Free Visual Perception Test, Berg Balance Scale, Functional Independence Measure, and JAKC Observational Gait Analysis. Assessments will be conducted at baseline, post-intervention, and follow-up. The study is expected to provide evidence on whether Fresnel prism glasses can serve as an effective adjunct to conventional rehabilitation for improving mobility, balance, and functional outcomes in stroke survivors.
Read the detailed description
Stroke is one of the leading causes of long-term disability worldwide and is frequently associated with impairments in balance, gait, motor function, and visuospatial perception. Among these deficits, unilateral spatial neglect (USN) is particularly common following right hemisphere stroke and significantly limits functional recovery. Individuals with USN often demonstrate impaired awareness of the contralesional space, distorted midline perception, postural asymmetry, and abnormal gait patterns, which collectively increase the risk of falls and dependence in activities of daily living. Despite advances in conventional stroke rehabilitation, including physical and occupational therapy, many patients continue to experience persistent functional limitations, highlighting the need for innovative and adjunctive rehabilitation strategies.
Recent developments in neurorehabilitation emphasize sensory-based interventions that promote neuroplasticity by modifying sensory input. Fresnel prism glasses represent a low-cost, non-invasive visual intervention designed to shift the visual field and facilitate visuospatial realignment. By altering visual input, Fresnel prisms may enhance sensory integration and improve postural control, balance, and gait performance in stroke survivors. Preliminary studies have demonstrated improvements in balance measures, gait symmetry, and visual perception following prism use; however, findings remain inconsistent, and evidence regarding functional outcomes and long-term effects is limited.
This randomized controlled trial aims to evaluate the effectiveness of Fresnel prism glasses as an adjunct to conventional physiotherapy in post-stroke patients. Eligible participants with a confirmed diagnosis of stroke will be randomly allocated into two groups: an experimental group receiving Fresnel prism glasses in addition to standard rehabilitation, and a control group receiving conventional physiotherapy alone. The intervention will be delivered over a defined treatment period, with assessments conducted at baseline and post-intervention.
Primary outcome measures will assess balance and postural control using standardized tools such as the Berg Balance Scale and Functional Reach Test. Secondary outcomes will include gait analysis, visual perception, and functional independence measured through validated clinical scales. The study also seeks to examine whether visual realignment through Fresnel prisms can facilitate weight transfer toward the affected side and reduce asymmetry during standing and walking.
The findings of this study are expected to contribute to the growing body of evidence on sensory-based rehabilitation interventions for stroke. By addressing current gaps related to functional outcomes and feasibility, this research may help establish Fresnel prism glasses as an effective, accessible adjunct therapy in stroke rehabilitation, particularly in resource-limited settings. Ultimately, the study aims to support improved mobility, independence, and quality of life among stroke survivors.
- Conditions
- Stroke
- Being tested
- Fresnel Prism Glasse, Convetional physical therapy
- Keywords
- Visual Perception, Functional Independence, Fresnel Prism Glasses, Gait, Balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fresnel Prism GlasseDevice
Fresnel prism glasses consist of lightweight, flexible, press-on plastic prism lenses with a power of 15 prism diopters, affixed to the inner surface of standard spectacle lenses. The prisms are designed to shift the visual field horizontally to promote visuospatial realignment and improve sensory integration during functional activities.
Participants assigned to the experimental group will wear Fresnel prism glasses during supervised physiotherapy sessions. The intervention will be administered alongside conventional physiotherapy, including balance training, gait training, postural control exercises, and functional mobility tasks. The prism glasses will be worn throughout the therapy session to facilitate visual feedback and encourage symmetrical weight-bearing and improved postural alignment.
The intervention will be delivered for a duration of 4 weeks, with sessions conducted 5 days per week. Each session will last approximately 30-45 minutes and will be supervised by a qualified
Convetional physical therapyBehavioural
Conventional physiotherapy will be provided to all participants in both groups according to standard neurorehabilitation protocols. The program will include balance exercises, gait training, strengthening exercises, postural alignment activities, weight-shifting exercises, and task-oriented functional training. Participants in the control group will receive conventional physiotherapy alone, without Fresnel prism glasses, for the same duration and frequency as the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Arm/group | Experimental | Participants allocated to the experimental group will receive Fresnel prism glasses (15 prism diopters) in addition to conventional physiotherapy. The Fresnel prism lenses will be affixed to the participant's spectacles to induce visuospatial realignment during therapeutic activities. Participants will wear the prism glasses during supervised rehabilitation sessions focused on balance training, gait training, and functional mobility tasks. Conventional physiotherapy will include postural control exercises, weight-shifting activities, gait re-education, and task-oriented functional training. The intervention will be administered for 4 weeks, with sessions conducted 5 days per week, under the supervision of a qualified physiotherapist. Receives: Device: Fresnel Prism Glasse; Behavioral: Convetional physical therapy |
| Arm/Group | Active comparator | Participants allocated to the control group will receive conventional physiotherapy alone, without the use of Fresnel prism glasses. The rehabilitation program will follow standard neurorehabilitation protocols and will include balance exercises, gait training, strengthening, postural alignment exercises, and functional mobility tasks. Therapy will be provided with the same frequency and duration as the experimental group (5 sessions per week for 4 weeks) to ensure comparability between groups. Receives: Behavioral: Convetional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor-Free Visual Perception Test
The Motor-Free Visual Perception Test (MVPT) is a standardized assessment tool consisting of 36 items that evaluate multiple domains of visual perception, including figure-ground discrimination, visual discrimination, visual memory, visual closure, and spatial relationships. It is designed to assess visual field deficits and overall visual perceptual function in patients who have experienced brain injuries or strokes. In this study, we measured participants' response behaviors to identify the extent of unilateral neglect by recording their responses to both the left and right sides of the body, regardless of accuracy. Correct responses are scored as raw points, while the total time taken to complete the assessment is recorded as the visual perceptual processing time. The maximum score achievable is 36 points. The MVPT demonstrates high reliability, with a test-retest intraclass correlation coefficient (ICC) of 0.92 (95% CI: 0.84-0.96). In this trial, the MVPT will be utilized.
Measured: Baseline, before intervention, 8 weeks post intervention
Berg Balance Scale
The Functional Independence Measure (FIM) is a key tool used to assess the level of disability in patients undergoing rehabilitation. It evaluates 18 different activities of daily living on a scale from 1 to 7, where 1 means the person is fully dependent and 7 means they can do everything independently without any assistance. The highest possible score is 126, which signifies complete functional independence, while the lowest score of 18 indicates total dependence. The activities are divided into two main categories: 13 motor skills (like personal care, sphincter control, mobility, and locomotion) and five cognitive skills (which include communication and social cognition)
Measured: baseline, before interventio, 8 weeks post intervention
Functional Independence Measure
Independence Measure (FIM) is a key tool used to assess the level of disability in patients undergoing rehabilitation. It evaluates 18 different activities of daily living on a scale from 1 to 7, where 1 means the person is fully dependent and 7 means they can do everything independently without any assistance(23). The highest possible score is 126, which signifies complete functional independence, while the lowest score of 18 indicates total dependence. The activities are divided into two main categories: 13 motor skills (like personal care, sphincter control, mobility, and locomotion) and five cognitive skills (which include communication and social cognition)
Measured: baseline, before intervention, 8 weeks post intervention
JAKC's Observational Gait Analysis
The JAKC Observational Gait Analysis (Joint Angle Kinematic Coordination) is a wellstructured clinical tool designed to evaluate gait patterns, especially in individuals dealing with neurological or musculoskeletal issues like stroke. It zeroes in on the coordination and quality of movement in key joints-namely the hip, knee, ankle, and trunk-throughout various stages of the gait cycle. By closely observing joint angles, timing, and how limbs work together, therapists can spot unusual movement patterns and compensatory behaviors. The JAKC scale aids in clinical decision-making by pinpointing specific gait deviations, which helps in crafting targeted interventions and tracking progress over time. It's a practical, non-invasive approach that's widely embraced in rehabilitation environments
Measured: Baseline, before intervention, 8 week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start13 Dec 2025 (estimated)
- Primary completion26 May 2026 (estimated)
- Study completion26 May 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 StrokeStudies of the same condition, open and under way.
- More trials run by Lahore University of Biological and Applied SciencesThe sponsor's other registered studies.
- 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
- After recruitment of participants into the study, they will be allocated to their respective group utilizing the online randomization tool.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308054
- Sponsor's protocol ID
- UBAS/ERB/FpRS/25/035
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ha SY, Sung YH. Effects of Fresnel prism glasses on balance and gait in stroke patients with hemiplegia: A randomized controlled trial pilot study. Technol Health Care. 2020;28(6):625-633. doi: 10.3233/THC-191973.
PubMed 32280072
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fresnel Prism Glasses on Visual Perception, Balance, Gait and Functional Independence in Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT07308054
- Acronym / sponsor ID
- UBAS/ERB/FpRS/25/035
- Conditions
- Stroke
- Keywords
- Visual Perception, Functional Independence, Fresnel Prism Glasses, Gait, Balance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Study start
- 13 Dec 2025 (estimated)
- Primary completion
- 26 May 2026 (estimated)
- Study completion
- 26 May 2026 (estimated)
- First posted
- 29 Dec 2025 (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.
This randomized controlled trial aims to evaluate the effects of Fresnel prism glasses on visual perception, balance, gait, and functional independence in post-stroke patients. Stroke survivors, particularly those with right hemisphere involvement, often experience visuospatial deficits such as unilateral spatial neglect, leading to impaired balance, abnormal gait, and reduced functional independence. Fresnel prism glasses offer a low-cost, non-invasive intervention that may improve visuospatial alignment and postural control by modifying visual input. Adult post-stroke patients will be randomly allocated into an intervention group receiving Fresnel prism glasses alongside conventional physical therapy, and a control group receiving conventional therapy alone. Outcome measures will include the Motor-Free Visual Perception Test, Berg Balance Scale, Functional Independence Measure, and JAKC Observational Gait Analysis. Assessments will be conducted at baseline, post-intervention, and follow-up. The study is expected to provide evidence on whether Fresnel prism glasses can serve as an effective adjunct to conventional rehabilitation for improving mobility, balance, and functional outcomes in stroke survivors.
Detailed description
Stroke is one of the leading causes of long-term disability worldwide and is frequently associated with impairments in balance, gait, motor function, and visuospatial perception. Among these deficits, unilateral spatial neglect (USN) is particularly common following right hemisphere stroke and significantly limits functional recovery. Individuals with USN often demonstrate impaired awareness of the contralesional space, distorted midline perception, postural asymmetry, and abnormal gait patterns, which collectively increase the risk of falls and dependence in activities of daily living. Despite advances in conventional stroke rehabilitation, including physical and occupational therapy, many patients continue to experience persistent functional limitations, highlighting the need for innovative and adjunctive rehabilitation strategies.
Recent developments in neurorehabilitation emphasize sensory-based interventions that promote neuroplasticity by modifying sensory input. Fresnel prism glasses represent a low-cost, non-invasive visual intervention designed to shift the visual field and facilitate visuospatial realignment. By altering visual input, Fresnel prisms may enhance sensory integration and improve postural control, balance, and gait performance in stroke survivors. Preliminary studies have demonstrated improvements in balance measures, gait symmetry, and visual perception following prism use; however, findings remain inconsistent, and evidence regarding functional outcomes and long-term effects is limited.
This randomized controlled trial aims to evaluate the effectiveness of Fresnel prism glasses as an adjunct to conventional physiotherapy in post-stroke patients. Eligible participants with a confirmed diagnosis of stroke will be randomly allocated into two groups: an experimental group receiving Fresnel prism glasses in addition to standard rehabilitation, and a control group receiving conventional physiotherapy alone. The intervention will be delivered over a defined treatment period, with assessments conducted at baseline and post-intervention.
Primary outcome measures will assess balance and postural control using standardized tools such as the Berg Balance Scale and Functional Reach Test. Secondary outcomes will include gait analysis, visual perception, and functional independence measured through validated clinical scales. The study also seeks to examine whether visual realignment through Fresnel prisms can facilitate weight transfer toward the affected side and reduce asymmetry during standing and walking.
The findings of this study are expected to contribute to the growing body of evidence on sensory-based rehabilitation interventions for stroke. By addressing current gaps related to functional outcomes and feasibility, this research may help establish Fresnel prism glasses as an effective, accessible adjunct therapy in stroke rehabilitation, particularly in resource-limited settings. Ultimately, the study aims to support improved mobility, independence, and quality of life among stroke survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- After recruitment of participants into the study, they will be allocated to their respective group utilizing the online randomization tool.
| Arm | Type | Receives |
|---|---|---|
| Arm/group | Experimental | Device: Fresnel Prism Glasse, Behavioral: Convetional physical therapyParticipants allocated to the experimental group will receive Fresnel prism glasses (15 prism diopters) in addition to conventional physiotherapy. The Fresnel prism lenses will be affixed to the participant's spectacles to induce visuospatial realignment during therapeutic activities. Participants will wear the prism glasses during supervised rehabilitation sessions focused on balance training, gait training, and functional mobility tasks. Conventional physiotherapy will include postural control exercises, weight-shifting activities, gait re-education, and task-oriented functional training. The intervention will be administered for 4 weeks, with sessions conducted 5 days per week, under the supervision of a qualified physiotherapist. |
| Arm/Group | Active comparator | Behavioral: Convetional physical therapyParticipants allocated to the control group will receive conventional physiotherapy alone, without the use of Fresnel prism glasses. The rehabilitation program will follow standard neurorehabilitation protocols and will include balance exercises, gait training, strengthening, postural alignment exercises, and functional mobility tasks. Therapy will be provided with the same frequency and duration as the experimental group (5 sessions per week for 4 weeks) to ensure comparability between groups. |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Fresnel Prism GlasseFresnel prism glasses consist of lightweight, flexible, press-on plastic prism lenses with a power of 15 prism diopters, affixed to the inner surface of standard spectacle lenses. The prisms are designed to shift the visual field horizontally to promote visuospatial realignment and improve sensory integration during functional activities. Participants assigned to the experimental group will wear Fresnel prism glasses during supervised physiotherapy sessions. The intervention will be administered alongside conventional physiotherapy, including balance training, gait training, postural control exercises, and functional mobility tasks. The prism glasses will be worn throughout the therapy session to facilitate visual feedback and encourage symmetrical weight-bearing and improved postural alignment. The intervention will be delivered for a duration of 4 weeks, with sessions conducted 5 days per week. Each session will last approximately 30-45 minutes and will be supervised by a qualified | Device | Arm/group |
| Convetional physical therapyConventional physiotherapy will be provided to all participants in both groups according to standard neurorehabilitation protocols. The program will include balance exercises, gait training, strengthening exercises, postural alignment activities, weight-shifting exercises, and task-oriented functional training. Participants in the control group will receive conventional physiotherapy alone, without Fresnel prism glasses, for the same duration and frequency as the experimental group. | Behavioural | Arm/Group, Arm/group |
Primary outcome
Motor-Free Visual Perception Test
Time frame: Baseline, before intervention, 8 weeks post intervention
The Motor-Free Visual Perception Test (MVPT) is a standardized assessment tool consisting of 36 items that evaluate multiple domains of visual perception, including figure-ground discrimination, visual discrimination, visual memory, visual closure, and spatial relationships. It is designed to assess visual field deficits and overall visual perceptual function in patients who have experienced brain injuries or strokes. In this study, we measured participants' response behaviors to identify the extent of unilateral neglect by recording their responses to both the left and right sides of the body, regardless of accuracy. Correct responses are scored as raw points, while the total time taken to complete the assessment is recorded as the visual perceptual processing time. The maximum score achievable is 36 points. The MVPT demonstrates high reliability, with a test-retest intraclass correlation coefficient (ICC) of 0.92 (95% CI: 0.84-0.96). In this trial, the MVPT will be utilized.
Berg Balance Scale
Time frame: baseline, before interventio, 8 weeks post intervention
The Functional Independence Measure (FIM) is a key tool used to assess the level of disability in patients undergoing rehabilitation. It evaluates 18 different activities of daily living on a scale from 1 to 7, where 1 means the person is fully dependent and 7 means they can do everything independently without any assistance. The highest possible score is 126, which signifies complete functional independence, while the lowest score of 18 indicates total dependence. The activities are divided into two main categories: 13 motor skills (like personal care, sphincter control, mobility, and locomotion) and five cognitive skills (which include communication and social cognition)
Functional Independence Measure
Time frame: baseline, before intervention, 8 weeks post intervention
Independence Measure (FIM) is a key tool used to assess the level of disability in patients undergoing rehabilitation. It evaluates 18 different activities of daily living on a scale from 1 to 7, where 1 means the person is fully dependent and 7 means they can do everything independently without any assistance(23). The highest possible score is 126, which signifies complete functional independence, while the lowest score of 18 indicates total dependence. The activities are divided into two main categories: 13 motor skills (like personal care, sphincter control, mobility, and locomotion) and five cognitive skills (which include communication and social cognition)
JAKC's Observational Gait Analysis
Time frame: Baseline, before intervention, 8 week post intervention
The JAKC Observational Gait Analysis (Joint Angle Kinematic Coordination) is a wellstructured clinical tool designed to evaluate gait patterns, especially in individuals dealing with neurological or musculoskeletal issues like stroke. It zeroes in on the coordination and quality of movement in key joints-namely the hip, knee, ankle, and trunk-throughout various stages of the gait cycle. By closely observing joint angles, timing, and how limbs work together, therapists can spot unusual movement patterns and compensatory behaviors. The JAKC scale aids in clinical decision-making by pinpointing specific gait deviations, which helps in crafting targeted interventions and tracking progress over time. It's a practical, non-invasive approach that's widely embraced in rehabilitation environments
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 29 Dec 2025.
- Results publication: PubMed 32280072Ha SY, Sung YH. Effects of Fresnel prism glasses on balance and gait in stroke patients with hemiplegia: A randomized controlled trial pilot study. Technol Health Care. 2020;28(6):625-633. doi: 10.3233/THC-191973.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Fresnel Prism Glasse and Convetional physical therapy in people with Stroke, run by Lahore University of Biological and Applied Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Muhammad Asad Azam, Master of physical therapy (+923217267679, asadazam10000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor-Free Visual Perception Test (time frame: Baseline, before intervention, 8 weeks post intervention). The study lists 4 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 NCT07308054, 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 29 Dec 2025.