Hypermobility Spectrum DisorderNCT07830589
Whole-Body Vibration and Postural Stability in Painful HSD
A study testing Conventional Exercise Program and Whole-Body Vibration in people with Hypermobility Spectrum Disorder, run by Gökalp Arif Utkugün at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to investigate the effects of adding whole-body vibration training to a conventional exercise program on postural stability and pain in painful women with hypermobility spectrum disorder. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Hypermobility Spectrum Disorder
- What is being tested?
- Conventional Exercise Program and Whole-Body Vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jul 2025to 9 Nov 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of hypermobility spectrum disorder (Beighton score ≥4/9)
- Female participants aged 18-45 years
- Presence of musculoskeletal pain for at least 3 months
Who cannot join
- Pregnancy
- Presence of a cardiac pacemaker, an implanted brain stimulator, a metal implant
- Acute or chronic arthritis
- Active malignancy
- Acute infection
- Initiation of medications that may affect proprioception or postural stability (e.g., antidepressants, antipsychotics, or hypnotics) within the previous 2 months
Show all 11Show fewer
- Regular exercise more than 3 days per week
- Postmenopausal status
- Orthopedic surgery within the previous 12 months
- Vertigo
- Acute painful conditions that would prevent participation in exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Whole-body Vibration Exercises on Postural Stability in Painful Women With Hypermobility Spectrum Disorders: A Randomized Controlled Trial
This randomized controlled trial aims to investigate the effects of adding whole-body vibration training to a conventional exercise program on postural stability and pain in painful women with hypermobility spectrum disorder. Participants are randomly allocated to conventional exercise or conventional exercise plus whole-body vibration groups and complete a 6-week supervised intervention program.
Read the detailed description
Participants were randomly allocated to two groups. One group received a conventional exercise program consisting of proprioceptive, core stabilization, and resistance exercises, while the other group received the same conventional exercise program combined with whole-body vibration exercises. Both groups participated in the exercise program for six weeks. All exercise sessions were conducted at the Department of Physical Medicine and Rehabilitation, Koç University Hospital, under the supervision of a resident physician. Participants were evaluated before and after the six-week intervention by a blinded outcome assessor who was unaware of the participants' group allocation.
- Conditions
- Hypermobility Spectrum Disorder
- Being tested
- Conventional Exercise Program, Whole-Body Vibration
- Keywords
- Joint Hypermobility, Whole-Body Vibration, Postural Stability, Balance, Pain, exercise
- Medical subject headings
- Joint Instability, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Exercise ProgramOther
A supervised exercise program consisting of proprioceptive, core stabilization, and resistance exercises was performed for six weeks. Exercises were progressively administered according to the study protocol under the supervision of a resident physician.
Whole-Body VibrationDevice
Also called Power Plate Pro5
Whole-body vibration exercises were performed using a Power Plate Pro5 vibration platform in addition to the conventional exercise program. The intervention was administered as part of the supervised six-week exercise program.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Exercise Group | Active comparator | Participants allocated to this arm received a supervised conventional exercise program consisting of proprioceptive, core stabilization, and resistance exercises for six weeks. Exercise sessions were conducted at the Department of Physical Medicine and Rehabilitation, Koç University Hospital, under the supervision of a resident physician. Receives: Other: Conventional Exercise Program |
| Conventional Exercise Plus Whole-Body Vibration Group | Experimental | Participants allocated to this arm received the same supervised conventional exercise program consisting of proprioceptive, core stabilization, and resistance exercises, with the addition of whole-body vibration exercises. The intervention was continued for six weeks. Exercise sessions were conducted at the Department of Physical Medicine and Rehabilitation, Koç University Hospital, under the supervision of a resident physician. Receives: Other: Conventional Exercise Program; Device: Whole-Body Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Velocity of Postural Sway
Static postural stability was assessed using three APDM Opal inertial measurement unit (IMU) sensors placed at the lumbar region and both feet. Mean velocity was automatically calculated by the APDM system and expressed in meters per second (m/sec). Eight conditions were assessed separately: double-leg firm surface eyes open/closed; tandem firm surface eyes open/closed; single-leg firm surface eyes open/closed; and single-leg foam surface eyes open/closed. In tandem stance, the dominant foot was in front; single-leg conditions were performed on the non-dominant leg. Lower values indicate less sway. Change = post-intervention minus baseline; negative values indicate reduced sway velocity.
Measured: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Path Length of Postural Sway
Static postural stability was assessed using three APDM Opal inertial measurement unit (IMU) sensors placed at the lumbar region and both feet. Path length was automatically calculated by the APDM system and expressed in meters per second squared (m/sec²). Eight conditions were assessed separately: double-leg firm surface eyes open/closed; tandem firm surface eyes open/closed; single-leg firm surface eyes open/closed; and single-leg foam surface eyes open/closed. In tandem stance, the dominant foot was in front; single-leg conditions were performed on the non-dominant leg. Lower values indicate less postural sway. Change = post-intervention minus baseline; negative values indicate reduced path length.
Measured: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Sway Area
Static postural stability was assessed using three APDM Opal inertial measurement unit (IMU) sensors placed at the lumbar region and both feet. Sway area was automatically calculated by the APDM system and expressed in square meters per second to the fourth power (m²/sec⁴). Eight conditions were assessed separately: double-leg firm surface eyes open/closed; tandem firm surface eyes open/closed; single-leg firm surface eyes open/closed; and single-leg foam surface eyes open/closed. In tandem stance, the dominant foot was in front; single-leg conditions were performed on the non-dominant leg. Lower values indicate less sway. Change = post-intervention minus baseline; negative values indicate reduced sway area.
Measured: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Normalized Reach Distance on the Star Excursion Balance Test
Dynamic postural stability was assessed with the Star Excursion Balance Test (SEBT). Reach distance was measured in the anterior, posteromedial, and posterolateral directions on both lower limbs. Three trials were performed for each direction, and the mean was normalized to the corresponding limb length: (mean reach distance / limb length) × 100. Results were expressed as % of limb length. Six values were analyzed separately: right and left anterior, posteromedial, and posterolateral reach. This is a continuous distance-based measure, with a minimum of 0% and no fixed maximum. Higher values indicate better reach performance. Change = post-intervention minus baseline; positive values indicate improvement.
Measured: Baseline and 3 to 10 days after completion of the 6-week intervention.
Secondary outcomes (8)
Change From Baseline in Isometric Muscle Strength Measured With a Hand-Held Dynamometer
Isometric muscle strength was assessed on the dominant side using a Lafayette hand-held dynamometer. The anterior deltoid and quadriceps were evaluated separately. Three maximal isometric trials were performed for each muscle group, and the highest value was used for analysis. Strength was expressed in Newtons (N). Higher values indicate greater isometric muscle strength. Change from baseline was calculated as the post-intervention value minus the baseline value; positive values indicate increased strength.
Measured: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Average Pain Intensity Assessed With the Numeric Rating Scale
Average pain intensity during the previous 2 weeks was assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 to 10. A score of 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity. Change from baseline was calculated as the post-intervention score minus the baseline score; negative values indicate a reduction in average pain intensity.
Measured: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Pressure Pain Threshold
Pressure pain threshold was assessed on the dominant side using a Wagner FDK20 pressure algometer at four sites: deltoid, trapezius, tibialis anterior, and the L3 paraspinal region. Three measurements were obtained at each site, and the mean of the final two was used for analysis. Results were expressed in kg/cm², and each site was analyzed separately. Higher values indicate a higher pressure pain threshold and lower mechanical pain sensitivity. Change = post-intervention minus baseline; positive values indicate increased pressure pain threshold.
Measured: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Dominant-Side Handgrip Strength
Handgrip strength of the dominant upper extremity was assessed using a Jamar digital hand dynamometer. Three maximal trials were performed, and the highest recorded value was used for analysis.
Handgrip strength was expressed in kilogram-force (kgf). Higher values indicate greater handgrip strength. Change from baseline was calculated as the post-intervention value minus the baseline value; positive change values indicate increased handgrip strength.
Measured: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in 6-Minute Walk Distance
Functional walking capacity was assessed using the 6-Minute Walk Test in a standardized 30-meter corridor. Participants were instructed to walk as far as possible during 6 minutes. The total distance walked was recorded in meters (m). Higher values indicate greater functional walking capacity. Change from baseline was calculated as the post-intervention distance minus the baseline distance; positive values indicate an increase in walking distance
Measured: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Body Weight
Body weight was measured using a body composition scale and recorded in kilograms (kg).
Change from baseline was calculated as the post-intervention body weight minus the baseline body weight.
Measured: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Body Fat Percentage
Body fat percentage was estimated using a body composition scale and expressed as a percentage (%) of total body weight. Change from baseline was calculated as the post-intervention body fat percentage minus the baseline body fat percentage.
Measured: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Muscle Mass
Muscle mass was estimated using a body composition scale and recorded in kilograms (kg). Change from baseline was calculated as the post-intervention muscle mass minus the baseline muscle mass.
Measured: Baseline and 3 to 10 days after completion of the 6-week intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start3 Jul 2025
- Primary completion5 Oct 2026 (estimated)
- Study completion9 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hypermobility Spectrum DisorderStudies 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
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gökalp Arif Utkugün
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gökalp Arif Utkugün, Koç University
- Investigators
- Gökalp Utkugün, MD, Principal investigator, Koc University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830589
- Sponsor's protocol ID
- 2025.296.IRB2.137
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available in order to protect participant confidentiality.
Publications
Mittal N, Santa Mina D, Buryk-Iggers S, Lopez-Hernandez L, Hussey L, Franzese A, Katz J, Laflamme C, McGillis L, McLean L, Rachinsky M, Rozenberg D, Slepian M, Weinrib A, Clarke H. The GoodHope Exercise and Rehabilitation (GEAR) Program for People With Ehlers-Danlos Syndromes and Generalized Hypermobility Spectrum Disorders. Front Rehabil Sci. 2021 Nov 8;2:769792. doi: 10.3389/fresc.2021.769792. eCollection 2021.
PubMed 36188836Ewertowska P, Formella O, Poniatowski L, Zielinska A, Krzysztofik M, Czaprowski D. Effect of whole-body vibration on postural stability in young adults with generalized joint hypermobility: A comparative study. J Back Musculoskelet Rehabil. 2024;37(5):1363-1371. doi: 10.3233/BMR-240004.
PubMed 38607750
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole-body Vibration Exercises on Postural Stability in Painful Women With Hypermobility Spectrum Disorders: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07830589
- Acronym / sponsor ID
- 2025.296.IRB2.137
- Conditions
- Hypermobility Spectrum Disorder
- Keywords
- Joint Hypermobility, Whole-Body Vibration, Postural Stability, Balance, Pain, exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gökalp Arif UtkugünUniversity, hospital or other
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 5 Oct 2026 (estimated)
- Study completion
- 9 Nov 2026 (estimated)
- First posted
- 21 Sep 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.
This randomized controlled trial aims to investigate the effects of adding whole-body vibration training to a conventional exercise program on postural stability and pain in painful women with hypermobility spectrum disorder. Participants are randomly allocated to conventional exercise or conventional exercise plus whole-body vibration groups and complete a 6-week supervised intervention program.
Detailed description
Participants were randomly allocated to two groups. One group received a conventional exercise program consisting of proprioceptive, core stabilization, and resistance exercises, while the other group received the same conventional exercise program combined with whole-body vibration exercises. Both groups participated in the exercise program for six weeks. All exercise sessions were conducted at the Department of Physical Medicine and Rehabilitation, Koç University Hospital, under the supervision of a resident physician. Participants were evaluated before and after the six-week intervention by a blinded outcome assessor who was unaware of the participants' group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Exercise Group | Active comparator | Other: Conventional Exercise ProgramParticipants allocated to this arm received a supervised conventional exercise program consisting of proprioceptive, core stabilization, and resistance exercises for six weeks. Exercise sessions were conducted at the Department of Physical Medicine and Rehabilitation, Koç University Hospital, under the supervision of a resident physician. |
| Conventional Exercise Plus Whole-Body Vibration Group | Experimental | Other: Conventional Exercise Program, Device: Whole-Body VibrationParticipants allocated to this arm received the same supervised conventional exercise program consisting of proprioceptive, core stabilization, and resistance exercises, with the addition of whole-body vibration exercises. The intervention was continued for six weeks. Exercise sessions were conducted at the Department of Physical Medicine and Rehabilitation, Koç University Hospital, under the supervision of a resident physician. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of hypermobility spectrum disorder (Beighton score ≥4/9)
- Female participants aged 18-45 years
- Presence of musculoskeletal pain for at least 3 months
Key exclusion criteria (11 listed)
- Pregnancy
- Presence of a cardiac pacemaker, an implanted brain stimulator, a metal implant
- Acute or chronic arthritis
- Active malignancy
- Acute infection
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 |
|---|---|---|
| Conventional Exercise ProgramA supervised exercise program consisting of proprioceptive, core stabilization, and resistance exercises was performed for six weeks. Exercises were progressively administered according to the study protocol under the supervision of a resident physician. | Other | Conventional Exercise Group, Conventional Exercise Plus Whole-Body Vibration Group |
| Whole-Body VibrationAlso: Power Plate Pro5Whole-body vibration exercises were performed using a Power Plate Pro5 vibration platform in addition to the conventional exercise program. The intervention was administered as part of the supervised six-week exercise program. | Device | Conventional Exercise Plus Whole-Body Vibration Group |
Primary outcome
Change From Baseline in Mean Velocity of Postural Sway
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Static postural stability was assessed using three APDM Opal inertial measurement unit (IMU) sensors placed at the lumbar region and both feet. Mean velocity was automatically calculated by the APDM system and expressed in meters per second (m/sec). Eight conditions were assessed separately: double-leg firm surface eyes open/closed; tandem firm surface eyes open/closed; single-leg firm surface eyes open/closed; and single-leg foam surface eyes open/closed. In tandem stance, the dominant foot was in front; single-leg conditions were performed on the non-dominant leg. Lower values indicate less sway. Change = post-intervention minus baseline; negative values indicate reduced sway velocity.
Change From Baseline in Path Length of Postural Sway
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Static postural stability was assessed using three APDM Opal inertial measurement unit (IMU) sensors placed at the lumbar region and both feet. Path length was automatically calculated by the APDM system and expressed in meters per second squared (m/sec²). Eight conditions were assessed separately: double-leg firm surface eyes open/closed; tandem firm surface eyes open/closed; single-leg firm surface eyes open/closed; and single-leg foam surface eyes open/closed. In tandem stance, the dominant foot was in front; single-leg conditions were performed on the non-dominant leg. Lower values indicate less postural sway. Change = post-intervention minus baseline; negative values indicate reduced path length.
Change From Baseline in Sway Area
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Static postural stability was assessed using three APDM Opal inertial measurement unit (IMU) sensors placed at the lumbar region and both feet. Sway area was automatically calculated by the APDM system and expressed in square meters per second to the fourth power (m²/sec⁴). Eight conditions were assessed separately: double-leg firm surface eyes open/closed; tandem firm surface eyes open/closed; single-leg firm surface eyes open/closed; and single-leg foam surface eyes open/closed. In tandem stance, the dominant foot was in front; single-leg conditions were performed on the non-dominant leg. Lower values indicate less sway. Change = post-intervention minus baseline; negative values indicate reduced sway area.
Change From Baseline in Normalized Reach Distance on the Star Excursion Balance Test
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Dynamic postural stability was assessed with the Star Excursion Balance Test (SEBT). Reach distance was measured in the anterior, posteromedial, and posterolateral directions on both lower limbs. Three trials were performed for each direction, and the mean was normalized to the corresponding limb length: (mean reach distance / limb length) × 100. Results were expressed as % of limb length. Six values were analyzed separately: right and left anterior, posteromedial, and posterolateral reach. This is a continuous distance-based measure, with a minimum of 0% and no fixed maximum. Higher values indicate better reach performance. Change = post-intervention minus baseline; positive values indicate improvement.
8 secondary outcomes
Change From Baseline in Isometric Muscle Strength Measured With a Hand-Held Dynamometer
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Average Pain Intensity Assessed With the Numeric Rating Scale
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Pressure Pain Threshold
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Dominant-Side Handgrip Strength
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in 6-Minute Walk Distance
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Body Weight
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Body Fat Percentage
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
Change From Baseline in Muscle Mass
Time frame: Baseline and 3 to 10 days after completion of the 6-week intervention.
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 23 Sep 2026.
- Background: PubMed 36188836Mittal N, Santa Mina D, Buryk-Iggers S, Lopez-Hernandez L, Hussey L, Franzese A, Katz J, Laflamme C, McGillis L, McLean L, Rachinsky M, Rozenberg D, Slepian M, Weinrib A, Clarke H. The GoodHope Exercise and Rehabilitation (GEAR) Program for People With Ehlers-Danlos Syndromes and Generalized Hypermobility Spectrum Disorders. Front Rehabil Sci. 2021 Nov 8;2:769792. doi: 10.3389/fresc.2021.769792. eCollection 2021.
- Background: PubMed 38607750Ewertowska P, Formella O, Poniatowski L, Zielinska A, Krzysztofik M, Czaprowski D. Effect of whole-body vibration on postural stability in young adults with generalized joint hypermobility: A comparative study. J Back Musculoskelet Rehabil. 2024;37(5):1363-1371. doi: 10.3233/BMR-240004.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available in order to protect participant confidentiality.
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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.
Gökalp Utkugün, MD principal investigator
Koc University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Exercise Program and Whole-Body Vibration in people with Hypermobility Spectrum Disorder, run by Gökalp Arif Utkugün at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 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 23 Sep 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 Turkey (Türkiye). 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 Mean Velocity of Postural Sway (time frame: Baseline and 3 to 10 days after completion of the 6-week 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 NCT07830589, which also lists 2 linked publications.
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 23 Sep 2026.