Pediatric BurnsNCT07590557
Plyometrics for Strength and Function After Pediatric Burns
A study testing Plyometric Training and Standard Exercise Program in people with Pediatric Burns and Burn Injury, run by Qassim University at 1 site in Saudi Arabia.
Trial summary
Pediatric burn survivors may experience persistent deficits in lower-limb strength, explosive power, and functional performance after hospital discharge. This randomized controlled trial evaluated whether a 12-week supervised plyometric training program improves lower-extremity muscle strength, power, and functional… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Pediatric Burns, Burn Injury, Post-Burn Rehabilitation
- What is being tested?
- Plyometric Training and Standard Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Apr 2024to 25 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children and adolescents aged 10-18 years at the time of enrolment.
- History of severe burn injury involving ≥30% total body surface area (TBSA), with lower-extremity involvement.
- Between 6 and 12 months post-hospital discharge.
- Ability to understand study instructions and safely perform the prescribed exercise program.
Who cannot join
- Pre-existing neurological or musculoskeletal disorders that may affect lower-limb function or study outcomes.
- Severe lower-limb joint contracture limiting functional movement.
- Cognitive impairment preventing understanding of instructions or reliable participation.
- Participation in another structured exercise, rehabilitation, or physical therapy program outside the study protocol during the trial period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rebuilding Capacity With Plyometrics: A Novel and Potent Stimulus for Strength and Power, and Functional Performance in Pediatric Post-Burn Population
Pediatric burn survivors may experience persistent deficits in lower-limb strength, explosive power, and functional performance after hospital discharge. This randomized controlled trial evaluated whether a 12-week supervised plyometric training program improves lower-extremity muscle strength, power, and functional capacity compared with a standard exercise program in children and adolescents with severe burn injuries.
Read the detailed description
This two-arm, parallel-group, single-blind randomized controlled trial included 62 pediatric burn survivors aged 10-18 years with severe burns involving ≥30% total body surface area and lower-limb involvement. Participants were recruited 6-12 months after hospital discharge and randomly allocated in a 1:1 ratio to either plyometric training or standard exercise.
Both groups received supervised exercise twice weekly for 12 weeks. The experimental group completed progressive plyometric exercises designed to enhance lower-extremity explosive power and dynamic functional mobility. The control group received standard post-discharge rehabilitation focused on flexibility, aerobic conditioning, mobility, and basic strengthening. Outcomes were assessed at baseline and immediately after the 12-week intervention by blinded assessors.
- Conditions
- Pediatric Burns, Burn Injury, Post-Burn Rehabilitation, Rehabilitation, Muscle Weakness, Functional Limitation
- Being tested
- Plyometric Training, Standard Exercise Program
- Keywords
- Pediatric burns, Rehabilitation, Plyometric training, Muscle strength, Muscle power, Functional performance
- Medical subject headings
- Burns, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plyometric TrainingOther
Also called Plyo-Tr group
Participants in the plyometric training group will receive a 12-week supervised program, with each session lasting 45 minutes and designed to improve lower-extremity explosive power and dynamic functional mobility. Sessions will include a 5-minute dynamic warm-up, 35 minutes of progressive plyometric exercises targeting vertical and horizontal force production, and a 5-minute cool-down. Training will be individually supervised with safety measures including shock-absorbing flooring, cushioned footwear, technique monitoring, and standardized rest intervals.
Standard Exercise ProgramOther
Also called Control Intervention
Participants in the control group will receive a 12-week supervised program, with each session lasting 45 minutes post-discharge burn rehabilitation program focusing on mobility, flexibility, aerobic conditioning, and basic lower-limb strengthening. Sessions will include warm-up, stretching, moderate-intensity aerobic exercise at 50-70% of age-predicted maximum heart rate, strengthening exercises, and cool-down, with progression based on participant tolerance.
| Study group | Role | What they receive |
|---|---|---|
| Plyometric Training Group | Experimental | Participants received a 12-week supervised plyometric training program, twice weekly, with each session lasting 45 minutes. Sessions included dynamic warm-up, progressive plyometric exercises targeting vertical and horizontal force production, and cool-down. Receives: Other: Plyometric Training |
| Standard Exercise Group | Active comparator | Participants received a 12-week supervised standard exercise program, twice weekly, with each session lasting 45 minutes. Sessions focused on flexibility, aerobic conditioning, mobility, and basic lower-limb strengthening. Receives: Other: Standard Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower-Limb Muscle Strength
Quadriceps and hamstring strength will be assessed using an isokinetic dynamometer. After standardized positioning, stabilization, warm-up, and familiarization, participants will perform five maximal reciprocal knee extension/flexion repetitions. The highest peak torque value (Nm) for hamstrings and quadriceps will be recorded.
Measured: pre-intervention (Week 0)
Lower-Limb Muscle Strength
Quadriceps and hamstring strength will be assessed using an isokinetic dynamometer. After standardized positioning, stabilization, warm-up, and familiarization, participants will perform five maximal reciprocal knee extension/flexion repetitions. The highest peak torque value (Nm) for hamstrings and quadriceps will be recorded.
Measured: immediately post-intervention (Week 12)
Secondary outcomes (16)
Vertical Jump Height
Vertical Jump Test: Lower-limb explosive power will be assessed using a vertical jump performed on a force plate. Participants will jump maximally with hands on hips to minimize arm contribution, completing three trials with 60 seconds of rest between trials. The highest jump height will be recorded in centimeters.
Measured: pre-intervention (Week 0)
Vertical Jump Height
Vertical Jump Test: Lower-limb explosive power will be assessed using a vertical jump performed on a force plate. Participants will jump maximally with hands on hips to minimize arm contribution, completing three trials with 60 seconds of rest between trials. The highest jump height will be recorded in centimeters.
Measured: immediately post-intervention (Week 12)
Broad Jump Distance
Horizontal lower-limb power and dynamic leg strength will be assessed using the broad jump test. Participants will perform three maximal two-footed forward jumps from a marked starting line, with 60 seconds of rest between trials. The longest distance, measured from the starting line to the rearmost landing point, will be recorded in centimeters.
Measured: pre-intervention (Week 0)
Broad Jump Distance
Horizontal lower-limb power and dynamic leg strength will be assessed using the broad jump test. Participants will perform three maximal two-footed forward jumps from a marked starting line, with 60 seconds of rest between trials. The longest distance, measured from the starting line to the rearmost landing point, will be recorded in centimeters.
Measured: immediately post-intervention (Week 12)
Reactive Strength Index
Reactive strength will be assessed using a drop jump from a 30-cm box onto a force plate. Three trials will be performed with 60 seconds of rest, and the highest reactive strength index value, calculated as jump height divided by ground contact time, will be recorded.
Measured: pre-intervention (Week 0)
Reactive Strength Index
Reactive strength will be assessed using a drop jump from a 30-cm box onto a force plate. Three trials will be performed with 60 seconds of rest, and the highest reactive strength index value, calculated as jump height divided by ground contact time, will be recorded.
Measured: immediately post-intervention (Week 12)
Lower Extremity Functional Scale Score
Lower-limb functional ability will be assessed using the 20-item Lower Extremity Functional Scale, which evaluates perceived difficulty in activities such as walking, running, stair climbing, and squatting. Each item is scored from 0 to 4, with a total score ranging from 0 to 80. Higher scores indicate better functional capacity.
Measured: pre-intervention (Week 0)
Lower Extremity Functional Scale Score
Lower-limb functional ability will be assessed using the 20-item Lower Extremity Functional Scale, which evaluates perceived difficulty in activities such as walking, running, stair climbing, and squatting. Each item is scored from 0 to 4, with a total score ranging from 0 to 80. Higher scores indicate better functional capacity.
Measured: immediately post-intervention (Week 12)
Six-Minute Walk Test Distance
Functional exercise capacity will be assessed using the Six-Minute Walk Test performed along a 30-meter indoor corridor according to standardized guidelines. Participants will be instructed to walk as far as possible, without running, within six minutes, and the total distance covered will be recorded in meters.
Measured: pre-intervention (Week 0)
Six-Minute Walk Test Distance
Functional exercise capacity will be assessed using the Six-Minute Walk Test performed along a 30-meter indoor corridor according to standardized guidelines. Participants will be instructed to walk as far as possible, without running, within six minutes, and the total distance covered will be recorded in meters.
Measured: immediately post-intervention (Week 12)
Timed Up and Down Stairs Performance
Lower-limb power, agility, and dynamic balance will be assessed using the Timed Up and Down Stairs test. Participants will ascend and descend 10 standard stairs as quickly and safely as possible, with two trials performed and the fastest time recorded in seconds.
Measured: pre-intervention (Week 0)
Timed Up and Down Stairs Performance
Lower-limb power, agility, and dynamic balance will be assessed using the Timed Up and Down Stairs test. Participants will ascend and descend 10 standard stairs as quickly and safely as possible, with two trials performed and the fastest time recorded in seconds.
Measured: immediately post-intervention (Week 12)
4×10-Meter Shuttle Run Time
Agility and speed will be assessed using the 4×10-meter shuttle run test. Participants will run back and forth between two cones placed 10 meters apart, completing four 10-meter segments for a total distance of 40 meters. Two trials will be performed, and the fastest completion time will be recorded in seconds.
Measured: pre-intervention (Week 0)
4×10-Meter Shuttle Run Time
Agility and speed will be assessed using the 4×10-meter shuttle run test. Participants will run back and forth between two cones placed 10 meters apart, completing four 10-meter segments for a total distance of 40 meters. Two trials will be performed, and the fastest completion time will be recorded in seconds.
Measured: immediately post-intervention (Week 12)
Figure-of-8 Walk/Run Test Time
Dynamic balance, agility, and coordination will be assessed using the Figure-of-8 Walk/Run Test. Participants will complete two full loops around two cones placed 5 meters apart as quickly as possible. Two trials will be performed, and the fastest completion time will be recorded in seconds.
Measured: pre-intervention (Week 0)
Figure-of-8 Walk/Run Test Time
Dynamic balance, agility, and coordination will be assessed using the Figure-of-8 Walk/Run Test. Participants will complete two full loops around two cones placed 5 meters apart as quickly as possible. Two trials will be performed, and the fastest completion time will be recorded in seconds.
Measured: immediately post-intervention (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Apr 2024
- Primary completion25 Mar 2025
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pediatric BurnsStudies 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
- Participants were randomized 1:1 to plyometric training or standard exercise for 12 weeks. Outcome assessors were blinded to group allocation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University
- Responsible party
- Principal investigator, Maged Basha, Qassim University
- Investigators
- Maged A Basha, PhD, Study director, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07590557
- Sponsor's protocol ID
- 2024-RHPT-017
- Status last verified
- May 2026
- First submitted
- 10 May 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data supporting the published results will be available from the corresponding author upon reasonable request.
Publications
Rivas E, Herndon DN, Cambiaso-Daniel J, Rontoyanni VG, Porter C, Glover S, Suman OE. Quantification of an Exercise Rehabilitation Program for Severely Burned Children: The Standard of Care at Shriners Hospitals for Children(R)-Galveston. J Burn Care Res. 2018 Oct 23;39(6):889-896. doi: 10.1093/jbcr/iry001.
PubMed 29596648Neriamparambil AJ, Sawhney R, Wong WL. Evidence-Based Management of Burns: A Narrative Review of Evolving Practices. Eur Burn J. 2025 Nov 10;6(4):59. doi: 10.3390/ebj6040059.
PubMed 41283468Elnaggar RK, Osailan AM, Alsubaie SF, Moawd SA, Abd El-Nabie WA. Graded aerobic exercise (GAEx): An effective exercise regimen to improve cardio-respiratory fitness and physical and psychosocial functioning in children with burn sequelae of the chest. Burns. 2022 Mar;48(2):337-344. doi: 10.1016/j.burns.2021.05.004. Epub 2021 May 13.
PubMed 34016485Knuth CM, Auger C, Jeschke MG. Burn-induced hypermetabolism and skeletal muscle dysfunction. Am J Physiol Cell Physiol. 2021 Jul 1;321(1):C58-C71. doi: 10.1152/ajpcell.00106.2021. Epub 2021 Apr 28.
PubMed 33909503
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rebuilding Capacity With Plyometrics: A Novel and Potent Stimulus for Strength and Power, and Functional Performance in Pediatric Post-Burn Population
- ClinicalTrials.gov ID
- NCT07590557
- Acronym / sponsor ID
- 2024-RHPT-017
- Conditions
- Pediatric Burns, Burn Injury, Post-Burn Rehabilitation, Rehabilitation, Muscle Weakness, Functional Limitation
- Keywords
- Pediatric burns, Rehabilitation, Plyometric training, Muscle strength, Muscle power, Functional performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Collaborators
- Prince Sattam Bin Abdulaziz University
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 25 Mar 2025 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 15 May 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.
Pediatric burn survivors may experience persistent deficits in lower-limb strength, explosive power, and functional performance after hospital discharge. This randomized controlled trial evaluated whether a 12-week supervised plyometric training program improves lower-extremity muscle strength, power, and functional capacity compared with a standard exercise program in children and adolescents with severe burn injuries.
Detailed description
This two-arm, parallel-group, single-blind randomized controlled trial included 62 pediatric burn survivors aged 10-18 years with severe burns involving ≥30% total body surface area and lower-limb involvement. Participants were recruited 6-12 months after hospital discharge and randomly allocated in a 1:1 ratio to either plyometric training or standard exercise.
Both groups received supervised exercise twice weekly for 12 weeks. The experimental group completed progressive plyometric exercises designed to enhance lower-extremity explosive power and dynamic functional mobility. The control group received standard post-discharge rehabilitation focused on flexibility, aerobic conditioning, mobility, and basic strengthening. Outcomes were assessed at baseline and immediately after the 12-week intervention by blinded assessors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomized 1:1 to plyometric training or standard exercise for 12 weeks. Outcome assessors were blinded to group allocation.
| Arm | Type | Receives |
|---|---|---|
| Plyometric Training Group | Experimental | Other: Plyometric TrainingParticipants received a 12-week supervised plyometric training program, twice weekly, with each session lasting 45 minutes. Sessions included dynamic warm-up, progressive plyometric exercises targeting vertical and horizontal force production, and cool-down. |
| Standard Exercise Group | Active comparator | Other: Standard Exercise ProgramParticipants received a 12-week supervised standard exercise program, twice weekly, with each session lasting 45 minutes. Sessions focused on flexibility, aerobic conditioning, mobility, and basic lower-limb strengthening. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Children and adolescents aged 10-18 years at the time of enrolment.
- History of severe burn injury involving ≥30% total body surface area (TBSA), with lower-extremity involvement.
- Between 6 and 12 months post-hospital discharge.
- Ability to understand study instructions and safely perform the prescribed exercise program.
Key exclusion criteria (4 listed)
- Pre-existing neurological or musculoskeletal disorders that may affect lower-limb function or study outcomes.
- Severe lower-limb joint contracture limiting functional movement.
- Cognitive impairment preventing understanding of instructions or reliable participation.
- Participation in another structured exercise, rehabilitation, or physical therapy program outside the study protocol during the trial period.
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 |
|---|---|---|
| Plyometric TrainingAlso: Plyo-Tr groupParticipants in the plyometric training group will receive a 12-week supervised program, with each session lasting 45 minutes and designed to improve lower-extremity explosive power and dynamic functional mobility. Sessions will include a 5-minute dynamic warm-up, 35 minutes of progressive plyometric exercises targeting vertical and horizontal force production, and a 5-minute cool-down. Training will be individually supervised with safety measures including shock-absorbing flooring, cushioned footwear, technique monitoring, and standardized rest intervals. | Other | Plyometric Training Group |
| Standard Exercise ProgramAlso: Control InterventionParticipants in the control group will receive a 12-week supervised program, with each session lasting 45 minutes post-discharge burn rehabilitation program focusing on mobility, flexibility, aerobic conditioning, and basic lower-limb strengthening. Sessions will include warm-up, stretching, moderate-intensity aerobic exercise at 50-70% of age-predicted maximum heart rate, strengthening exercises, and cool-down, with progression based on participant tolerance. | Other | Standard Exercise Group |
Primary outcome
Lower-Limb Muscle Strength
Time frame: pre-intervention (Week 0)
Quadriceps and hamstring strength will be assessed using an isokinetic dynamometer. After standardized positioning, stabilization, warm-up, and familiarization, participants will perform five maximal reciprocal knee extension/flexion repetitions. The highest peak torque value (Nm) for hamstrings and quadriceps will be recorded.
Lower-Limb Muscle Strength
Time frame: immediately post-intervention (Week 12)
Quadriceps and hamstring strength will be assessed using an isokinetic dynamometer. After standardized positioning, stabilization, warm-up, and familiarization, participants will perform five maximal reciprocal knee extension/flexion repetitions. The highest peak torque value (Nm) for hamstrings and quadriceps will be recorded.
16 secondary outcomes
Vertical Jump Height
Time frame: pre-intervention (Week 0)
Vertical Jump Height
Time frame: immediately post-intervention (Week 12)
Broad Jump Distance
Time frame: pre-intervention (Week 0)
Broad Jump Distance
Time frame: immediately post-intervention (Week 12)
Reactive Strength Index
Time frame: pre-intervention (Week 0)
Reactive Strength Index
Time frame: immediately post-intervention (Week 12)
Lower Extremity Functional Scale Score
Time frame: pre-intervention (Week 0)
Lower Extremity Functional Scale Score
Time frame: immediately post-intervention (Week 12)
Six-Minute Walk Test Distance
Time frame: pre-intervention (Week 0)
Six-Minute Walk Test Distance
Time frame: immediately post-intervention (Week 12)
Timed Up and Down Stairs Performance
Time frame: pre-intervention (Week 0)
Timed Up and Down Stairs Performance
Time frame: immediately post-intervention (Week 12)
4×10-Meter Shuttle Run Time
Time frame: pre-intervention (Week 0)
4×10-Meter Shuttle Run Time
Time frame: immediately post-intervention (Week 12)
Figure-of-8 Walk/Run Test Time
Time frame: pre-intervention (Week 0)
Figure-of-8 Walk/Run Test Time
Time frame: immediately post-intervention (Week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 29596648Rivas E, Herndon DN, Cambiaso-Daniel J, Rontoyanni VG, Porter C, Glover S, Suman OE. Quantification of an Exercise Rehabilitation Program for Severely Burned Children: The Standard of Care at Shriners Hospitals for Children(R)-Galveston. J Burn Care Res. 2018 Oct 23;39(6):889-896. doi: 10.1093/jbcr/iry001.
- Background: PubMed 41283468Neriamparambil AJ, Sawhney R, Wong WL. Evidence-Based Management of Burns: A Narrative Review of Evolving Practices. Eur Burn J. 2025 Nov 10;6(4):59. doi: 10.3390/ebj6040059.
- Results publication: PubMed 34016485Elnaggar RK, Osailan AM, Alsubaie SF, Moawd SA, Abd El-Nabie WA. Graded aerobic exercise (GAEx): An effective exercise regimen to improve cardio-respiratory fitness and physical and psychosocial functioning in children with burn sequelae of the chest. Burns. 2022 Mar;48(2):337-344. doi: 10.1016/j.burns.2021.05.004. Epub 2021 May 13.
- Results publication: PubMed 33909503Knuth CM, Auger C, Jeschke MG. Burn-induced hypermetabolism and skeletal muscle dysfunction. Am J Physiol Cell Physiol. 2021 Jul 1;321(1):C58-C71. doi: 10.1152/ajpcell.00106.2021. Epub 2021 Apr 28.
- Individual participant dataSharing planned: Yes. De-identified individual participant data supporting the published results will be available from the corresponding author upon reasonable request.
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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.
Maged A Basha, PhD study director
Qassim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plyometric Training and Standard Exercise Program in people with Pediatric Burns and Burn Injury, run by Qassim University at 1 site in Saudi Arabia.
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 4 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 15 May 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lower-Limb Muscle Strength (time frame: pre-intervention (Week 0)). 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 NCT07590557, which also lists 4 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 15 May 2026.