Proprioceptive TrainingNCT07681609
Proprioceptive Exercise in Parkinson's Disease
A study testing Proprioceptive treaning and Physiotherapy in people with Proprioceptive Training and Physiotherapy, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial summary
Parkinson's disease is frequently associated with impaired postural control, balance deficits, trunk misalignment, altered proprioception, and an increased risk of falls. These impairments may contribute to reduced mobility, pain, loss of independence, and decreased quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proprioceptive Training, Physiotherapy
- What is being tested?
- Proprioceptive treaning and Physiotherapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 31 May 2021to 15 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18 years.
- Clinical diagnosis of Parkinson's disease.
- Modified Hoehn and Yahr stage between 1.5 and 3.
- Presence of postural and/or motor deficits related to Parkinson's disease.
- Ability to understand and follow the proposed rehabilitation and assessment procedures.
Who cannot join
- Spinal or upper-limb conditions requiring the use of fixed corrective devices.
- Inability to understand the proposed task or to follow study procedures.
- Severe comorbidities that may interfere with participation in the rehabilitation program or outcome assessment.
- Severe spinal arthrosis or other severe musculoskeletal conditions affecting the spine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Effectiveness of a Sensorized Bed for Proprioceptive Rehabilitation in Patients With Parkinson's Disease
Parkinson's disease is frequently associated with impaired postural control, balance deficits, trunk misalignment, altered proprioception, and an increased risk of falls. These impairments may contribute to reduced mobility, pain, loss of independence, and decreased quality of life. Although rehabilitation is a key component of Parkinson's disease management, conventional approaches often focus primarily on motor training, while sensory and proprioceptive aspects of postural control may receive less specific attention.
The aim of this randomized controlled longitudinal study is to evaluate the feasibility and preliminary efficacy of SuPerSense, a CE-marked sensorized proprioceptive rehabilitation table, in individuals with Parkinson's disease. SuPerSense is designed to detect pressure distribution on multiple contact points placed under the participant's back while lying on the device. The system provides quantitative information about trunk loading and symmetry, allowing the therapist to guide the patient during proprioceptive exercises and to provide visual feedback and positive reinforcement during training.
Read more
Participants with clinically diagnosed Parkinson's disease and postural or motor deficits will be randomized to either an experimental group or a control group. Both groups will receive the same amount of standard neuromotor rehabilitation. In addition, the experimental group will receive SuPerSense-based proprioceptive trunk rehabilitation three times per week for four weeks, for a total of 12 sessions. Each session will last approximately 30 minutes and will include periods of supine positioning with knees extended or flexed, followed by active proprioceptive exercises focused on perceiving back-contact information and improving symmetry of trunk loading. The control group will receive conventional rehabilitation for posture and balance with the same frequency and duration.
Assessments will be performed before and after the one-month rehabilitation period. Outcome measures will include objective postural and gait parameters collected using a baropodometric and stabilometric platform and an inertial gait analysis system. Clinical measures will include balance and gait scales, such as the Tinetti Balance and Gait assessments, the Berg Balance Scale, and a numerical rating scale for back pain. Participants will also undergo an assessment session with the SuPerSense device before and after treatment, in order to compare device-derived measures with standard instrumental and clinical outcomes.
The study is expected to provide information on the feasibility of sensorized proprioceptive trunk rehabilitation in Parkinson's disease and on the immediate and medium-term effects of the SuPerSense system on posture, balance, gait function, and pain. The results may support the integration of quantitative sensory-proprioceptive feedback into rehabilitation programs for individuals with Parkinson's disease.
Read the detailed description
Parkinson's disease (PD) is frequently associated with impaired postural control, balance deficits, trunk misalignment, altered proprioception, gait impairment, back pain, and increased risk of falls. These alterations may negatively affect mobility, independence, social participation, and quality of life (QoL). In PD, postural and balance disorders may include increased dorsal kyphosis, trunk flexion, lateral trunk deviation, Pisa syndrome, camptocormia, altered perception of the trunk midline, and impaired sensory-motor integration. Since balance control depends on the integration of sensory, proprioceptive, vestibular, and visual information, rehabilitation approaches targeting proprioceptive awareness and trunk symmetry may represent a useful complement to conventional neuromotor rehabilitation.
The aim of this randomized controlled trial (RCT) longitudinal study is to evaluate the feasibility and preliminary efficacy of SuPerSense (SPS), a Conformité Européenne (CE)-marked sensorized proprioceptive rehabilitation table, in individuals with PD. SPS is an electromedical device designed to detect the distribution of pressure exerted by the participant's back on multiple contact points. The device consists of a motorized support surface equipped with removable latex cones and sensorized areas connected to a software interface. The system provides quantitative information about trunk loading and pressure distribution, allowing the therapist to monitor the execution of the exercise, guide the participant, and provide feedback during proprioceptive rehabilitation.
A total of 24 participants with clinically diagnosed PD and postural or motor deficits will be enrolled and randomized to one of two groups: an experimental group (EG) receiving SuPerSense-based proprioceptive rehabilitation (SPS-PR) in addition to standard neuromotor rehabilitation, and a control group (CG) receiving conventional rehabilitation focused on posture and balance. Each group will include 12 participants.
The total expected duration of the study is 36 months from ethics committee approval. For each participant with PD, participation will last approximately one month. The study will be conducted at the Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Fondazione Santa Lucia, Rome, and Policlinico Universitario Campus Bio-Medico.
Participants with PD will be eligible if they are older than 18 years and have a clinical diagnosis of PD with a modified Hoehn and Yahr (H\&Y) stage between 1.5 and 3. Exclusion criteria include spinal or upper-limb conditions requiring fixed corrective devices, inability to understand the proposed task, and severe comorbidities, including severe arthrosis of the spine.
Both PD groups will receive the same overall amount of neuromotor rehabilitation, consisting of approximately three hours per day of rehabilitation. Within this rehabilitation program, the EG will receive 12 sessions of treatment with the SPS device, delivered three times per week for four weeks. Each SPS session will last approximately 30 minutes. During the session, the participant will lie on the device and will perform proprioceptive trunk exercises. The session will include one minute in supine position with knees extended, one minute with knees flexed, and two active treatment phases lasting approximately 10 minutes each. During the active phases, the participant will be asked to focus on the sensations arising from the contact points on the back and to improve symmetry of trunk loading. Rest periods and additional positioning phases with knees flexed and extended will be included between and after the active treatment phases. The therapist will use the quantitative information provided by the device to guide the participant and support correct task execution.
The CG will receive CR aimed at improving posture and balance, with the same frequency and duration as the SPS-PR intervention. Blinding of participants to group allocation is not feasible because of the nature of the intervention. Instrumental assessments will be performed using computerized devices to obtain objective and reproducible measures.
All participants with PD will be evaluated before and after the one-month rehabilitation period. Instrumental assessments will include gait analysis using the G-Walk inertial measurement unit (IMU) sensor system and postural assessment using the FreeMed baropodometric and stabilometric platform. The FreeMed platform will be used to collect static baropodometric measures, dynamic baropodometric measures, and stabilometric parameters. G-Walk will be used to assess accelerometer-based gait parameters. Clinical assessments will include the Tinetti Balance Scale (TBS), the Tinetti Gait Scale (TGS), the Berg Balance Scale (BBS), and a Numerical Rating Scale (NRS) for back pain.
Participants with PD will also undergo an SPS assessment session before and after the rehabilitation period. Data extracted from the SPS device will be compared with data obtained from the baropodometric/stabilometric platform, the IMU-based gait analysis system, and clinical scales. This will allow exploration of the validity of device-derived measures and their sensitivity to changes following rehabilitation.
The primary objective of the study is to assess the feasibility of a sensorized proprioceptive trunk rehabilitation program using SPS in individuals with PD. Secondary objectives are to evaluate the immediate and medium-term effects of SPS-PR on postural stability, gait function, trunk symmetry, balance, and back pain. The study will also explore whether quantitative pressure-distribution measures obtained from the SPS device can provide clinically meaningful information for monitoring proprioceptive rehabilitation in PD.
- Conditions
- Proprioceptive Training, Physiotherapy
- Being tested
- Proprioceptive treaning, Physiotherapy
- Keywords
- sensorised surface, proprioceptive training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive treaningDevice
Proprioceptive training carried out using a sensorised surface
PhysiotherapyBehavioural
conventional physiotherapy exercises
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive rehabilitation | Experimental | Proprioceptive rehabilitation with sensorised surface Receives: Device: Proprioceptive treaning |
| physiotherapy | Active comparator | Conventional physiotherapy Receives: Behavioral: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in postural stability measured by stabilometric assessment
Postural stability will be assessed using the FreeMed stabilometric platform. Stabilometric parameters such as the centre of pressure (CoP) trajectory measured in centimeters, will be collected during standing assessment to quantify changes in static postural control after the rehabilitation program.
Measured: Baseline (Day 0) and after 4 weeks (Day 28) of rehabilitation
Secondary outcomes (3)
Change from baseline in gait speed measured by G-Walk
Gait speed ( expressed in meter/seconds) will be measured using the G-Walk inertial sensor system during walking assessment.
Measured: Baseline (Day 0) and after 4 weeks of rehabilitation (Day 28).
Change from baseline in Berg Balance Scale score
Balance performance will be assessed using the Berg Balance Scale (BBS). The scale includes 14 functional balance tasks, each scored from 0 to 4. A score of 0 indicates inability to perform the task, whereas a score of 4 indicates independent and safe performance. The total score ranges from 0 to 56, with higher scores indicating better balance performance. The change in total score from baseline to the end of the rehabilitation program will be used to evaluate clinical changes in balance.
Measured: From baseline (Day 0) up to four weeks of treatment (Day 28)
Change from baseline in Tinetti Balance score
Balance will be assessed using the balance section of the Tinetti Performance-Oriented Mobility Assessment (POMA). The balance section ranges from 0 to 16, with higher scores indicating better balance performance and lower fall risk. An increase in the score indicates improvement.
Measured: Day 0 (baseline) and Day 28 (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start31 May 2021
- Primary completion1 Apr 2025
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proprioceptive TrainingStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Morone, PhD, Associate Professor, Principal investigator, IRRCS Santa Lucia foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681609
- Sponsor's protocol ID
- PerceptiveRehab
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available under request to corresponding Author after publications
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of a Sensorized Bed for Proprioceptive Rehabilitation in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07681609
- Acronym / sponsor ID
- PerceptiveRehab
- Conditions
- Proprioceptive Training, Physiotherapy
- Keywords
- sensorised surface, proprioceptive training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 31 May 2021 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 2 Jul 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.
Parkinson's disease is frequently associated with impaired postural control, balance deficits, trunk misalignment, altered proprioception, and an increased risk of falls. These impairments may contribute to reduced mobility, pain, loss of independence, and decreased quality of life. Although rehabilitation is a key component of Parkinson's disease management, conventional approaches often focus primarily on motor training, while sensory and proprioceptive aspects of postural control may receive less specific attention.
The aim of this randomized controlled longitudinal study is to evaluate the feasibility and preliminary efficacy of SuPerSense, a CE-marked sensorized proprioceptive rehabilitation table, in individuals with Parkinson's disease. SuPerSense is designed to detect pressure distribution on multiple contact points placed under the participant's back while lying on the device. The system provides quantitative information about trunk loading and symmetry, allowing the therapist to guide the patient during proprioceptive exercises and to provide visual feedback and positive reinforcement during training.
Participants with clinically diagnosed Parkinson's disease and postural or motor deficits will be randomized to either an experimental group or a control group. Both groups will receive the same amount of standard neuromotor rehabilitation. In addition, the experimental group will receive SuPerSense-based proprioceptive trunk rehabilitation three times per week for four weeks, for a total of 12 sessions. Each session will last approximately 30 minutes and will include periods of supine positioning with knees extended or flexed, followed by active proprioceptive exercises focused on perceiving back-contact information and improving symmetry of trunk loading. The control group will receive conventional rehabilitation for posture and balance with the same frequency and duration.
Assessments will be performed before and after the one-month rehabilitation period. Outcome measures will include objective postural and gait parameters collected using a baropodometric and stabilometric platform and an inertial gait analysis system. Clinical measures will include balance and gait scales, such as the Tinetti Balance and Gait assessments, the Berg Balance Scale, and a numerical rating scale for back pain. Participants will also undergo an assessment session with the SuPerSense device before and after treatment, in order to compare device-derived measures with standard instrumental and clinical outcomes.
The study is expected to provide information on the feasibility of sensorized proprioceptive trunk rehabilitation in Parkinson's disease and on the immediate and medium-term effects of the SuPerSense system on posture, balance, gait function, and pain. The results may support the integration of quantitative sensory-proprioceptive feedback into rehabilitation programs for individuals with Parkinson's disease.
Detailed description
Parkinson's disease (PD) is frequently associated with impaired postural control, balance deficits, trunk misalignment, altered proprioception, gait impairment, back pain, and increased risk of falls. These alterations may negatively affect mobility, independence, social participation, and quality of life (QoL). In PD, postural and balance disorders may include increased dorsal kyphosis, trunk flexion, lateral trunk deviation, Pisa syndrome, camptocormia, altered perception of the trunk midline, and impaired sensory-motor integration. Since balance control depends on the integration of sensory, proprioceptive, vestibular, and visual information, rehabilitation approaches targeting proprioceptive awareness and trunk symmetry may represent a useful complement to conventional neuromotor rehabilitation.
The aim of this randomized controlled trial (RCT) longitudinal study is to evaluate the feasibility and preliminary efficacy of SuPerSense (SPS), a Conformité Européenne (CE)-marked sensorized proprioceptive rehabilitation table, in individuals with PD. SPS is an electromedical device designed to detect the distribution of pressure exerted by the participant's back on multiple contact points. The device consists of a motorized support surface equipped with removable latex cones and sensorized areas connected to a software interface. The system provides quantitative information about trunk loading and pressure distribution, allowing the therapist to monitor the execution of the exercise, guide the participant, and provide feedback during proprioceptive rehabilitation.
A total of 24 participants with clinically diagnosed PD and postural or motor deficits will be enrolled and randomized to one of two groups: an experimental group (EG) receiving SuPerSense-based proprioceptive rehabilitation (SPS-PR) in addition to standard neuromotor rehabilitation, and a control group (CG) receiving conventional rehabilitation focused on posture and balance. Each group will include 12 participants.
The total expected duration of the study is 36 months from ethics committee approval. For each participant with PD, participation will last approximately one month. The study will be conducted at the Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Fondazione Santa Lucia, Rome, and Policlinico Universitario Campus Bio-Medico.
Participants with PD will be eligible if they are older than 18 years and have a clinical diagnosis of PD with a modified Hoehn and Yahr (H\&Y) stage between 1.5 and 3. Exclusion criteria include spinal or upper-limb conditions requiring fixed corrective devices, inability to understand the proposed task, and severe comorbidities, including severe arthrosis of the spine.
Both PD groups will receive the same overall amount of neuromotor rehabilitation, consisting of approximately three hours per day of rehabilitation. Within this rehabilitation program, the EG will receive 12 sessions of treatment with the SPS device, delivered three times per week for four weeks. Each SPS session will last approximately 30 minutes. During the session, the participant will lie on the device and will perform proprioceptive trunk exercises. The session will include one minute in supine position with knees extended, one minute with knees flexed, and two active treatment phases lasting approximately 10 minutes each. During the active phases, the participant will be asked to focus on the sensations arising from the contact points on the back and to improve symmetry of trunk loading. Rest periods and additional positioning phases with knees flexed and extended will be included between and after the active treatment phases. The therapist will use the quantitative information provided by the device to guide the participant and support correct task execution.
The CG will receive CR aimed at improving posture and balance, with the same frequency and duration as the SPS-PR intervention. Blinding of participants to group allocation is not feasible because of the nature of the intervention. Instrumental assessments will be performed using computerized devices to obtain objective and reproducible measures.
All participants with PD will be evaluated before and after the one-month rehabilitation period. Instrumental assessments will include gait analysis using the G-Walk inertial measurement unit (IMU) sensor system and postural assessment using the FreeMed baropodometric and stabilometric platform. The FreeMed platform will be used to collect static baropodometric measures, dynamic baropodometric measures, and stabilometric parameters. G-Walk will be used to assess accelerometer-based gait parameters. Clinical assessments will include the Tinetti Balance Scale (TBS), the Tinetti Gait Scale (TGS), the Berg Balance Scale (BBS), and a Numerical Rating Scale (NRS) for back pain.
Participants with PD will also undergo an SPS assessment session before and after the rehabilitation period. Data extracted from the SPS device will be compared with data obtained from the baropodometric/stabilometric platform, the IMU-based gait analysis system, and clinical scales. This will allow exploration of the validity of device-derived measures and their sensitivity to changes following rehabilitation.
The primary objective of the study is to assess the feasibility of a sensorized proprioceptive trunk rehabilitation program using SPS in individuals with PD. Secondary objectives are to evaluate the immediate and medium-term effects of SPS-PR on postural stability, gait function, trunk symmetry, balance, and back pain. The study will also explore whether quantitative pressure-distribution measures obtained from the SPS device can provide clinically meaningful information for monitoring proprioceptive rehabilitation in PD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive rehabilitation | Experimental | Device: Proprioceptive treaningProprioceptive rehabilitation with sensorised surface |
| physiotherapy | Active comparator | Behavioral: PhysiotherapyConventional physiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age older than 18 years.
- Clinical diagnosis of Parkinson's disease.
- Modified Hoehn and Yahr stage between 1.5 and 3.
- Presence of postural and/or motor deficits related to Parkinson's disease.
- Ability to understand and follow the proposed rehabilitation and assessment procedures.
Key exclusion criteria (4 listed)
- Spinal or upper-limb conditions requiring the use of fixed corrective devices.
- Inability to understand the proposed task or to follow study procedures.
- Severe comorbidities that may interfere with participation in the rehabilitation program or outcome assessment.
- Severe spinal arthrosis or other severe musculoskeletal conditions affecting the spine.
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 |
|---|---|---|
| Proprioceptive treaningProprioceptive training carried out using a sensorised surface | Device | Proprioceptive rehabilitation |
| Physiotherapyconventional physiotherapy exercises | Behavioural | physiotherapy |
Primary outcome
Change from baseline in postural stability measured by stabilometric assessment
Time frame: Baseline (Day 0) and after 4 weeks (Day 28) of rehabilitation
Postural stability will be assessed using the FreeMed stabilometric platform. Stabilometric parameters such as the centre of pressure (CoP) trajectory measured in centimeters, will be collected during standing assessment to quantify changes in static postural control after the rehabilitation program.
3 secondary outcomes
Change from baseline in gait speed measured by G-Walk
Time frame: Baseline (Day 0) and after 4 weeks of rehabilitation (Day 28).
Change from baseline in Berg Balance Scale score
Time frame: From baseline (Day 0) up to four weeks of treatment (Day 28)
Change from baseline in Tinetti Balance score
Time frame: Day 0 (baseline) and Day 28 (end of treatment)
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 6 Jul 2026.
- Individual participant dataSharing planned: No. Data will be available under request to corresponding Author after publications
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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.
Giovanni Morone, PhD, Associate Professor principal investigator
IRRCS Santa Lucia foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive treaning and Physiotherapy in people with Proprioceptive Training and Physiotherapy, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 6 Jul 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 Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
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?
Change from baseline in postural stability measured by stabilometric assessment (time frame: Baseline (Day 0) and after 4 weeks (Day 28) of rehabilitation). 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 6 Jul 2026.