Bone LengtheningNCT07731022
Video Feedback-Supported Rehabilitation After Bilateral Femoral Lengthening
A study testing Video Feedback-Supported Gait Training and Conventional Physiotherapy in people with Bone Lengthening and Gait Disorders, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled study aims to investigate the effects of adding video feedback-supported gait training to a standard rehabilitation program in individuals undergoing cosmetic bilateral femoral lengthening surgery. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Lengthening, Gait Disorders
- What is being tested?
- Video Feedback-Supported Gait Training and Conventional Physiotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 25 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 45 years
- Scheduled to undergo cosmetic bilateral femoral lengthening surgery using the Lengthening Over Nail technique
- Able and willing to participate regularly in the preoperative and postoperative assessments and rehabilitation program
- Able to understand the study procedures and follow the physiotherapist's instructions
- Willing to provide written informed consent
Who cannot join
- - Presence of a congenital, neurological, or rheumatological disorder
- Previous major orthopedic surgery affecting the lower extremities
- Presence of cerebral palsy, muscular dystrophy, peripheral neuropathy, or another neuromuscular disorder
- Advanced deformity, contracture, or osteoarthritis affecting the hip, knee, or ankle
- Psychiatric illness or cognitive impairment that may affect participation or adherence
- Any medical or postoperative complication preventing regular participation in the rehabilitation program
- Considered unsuitable for continued participation by the treating physician or research team
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Private Esencan Hospital
Istanbul, Eyalet/Yerleşke, 34517
FATMA ÇAVDARCI, PhD Student, 05374590918, cvdrcftm@gmail.com
About this study
Official title: Effects of Video Feedback-Supported Rehabilitation on Functional Outcomes in Individuals Undergoing Cosmetic Bilateral Femoral Lengthening: A Randomized Controlled Trial
This randomized controlled study aims to investigate the effects of adding video feedback-supported gait training to a standard rehabilitation program in individuals undergoing cosmetic bilateral femoral lengthening surgery.
A total of 32 adults aged 18-45 years who undergo cosmetic bilateral femoral lengthening using the Lengthening Over Nail (LON) technique will be included. All surgical procedures will be performed at Private Esencan Hospital. Participants will be monitored at the hospital for the first 6 postoperative days, and the distraction phase will begin on postoperative day 7. After discharge, rehabilitation will continue at BNB Health Services and Consultancy Center.
Read more
Participants will be assigned to an intervention group or a control group using block randomization at a 1:1 ratio. Both groups will receive rehabilitation 5 days per week, with each session lasting 50 minutes. The control group will receive 50 minutes of conventional physiotherapy. The intervention group will receive 40 minutes of conventional physiotherapy and 10 minutes of video feedback-supported gait training.
Assessments will be performed before surgery (T0), when approximately 4 cm of lengthening has been achieved (T1), when approximately 8 cm of lengthening has been achieved (T2), and 2 weeks after removal of the external fixator (T3).
The primary outcome will be walking performance assessed using the 10-Meter Walk Test. Secondary outcomes will include lower-extremity function, kinesiophobia, body awareness, quadriceps muscle strength, and pressure pain threshold.
Read the detailed description
Cosmetic limb-lengthening surgery has become increasingly common among individuals seeking an increase in height. The Lengthening Over Nail (LON) technique reduces the duration of external fixation and provides greater mechanical stability. However, the lengthening process affects not only bone tissue but also muscles, tendons, connective tissues, blood vessels, and the nervous system.
During distraction osteogenesis, approximately 1 mm of lengthening is generally performed each day. The resulting continuous mechanical tension on the soft tissues may lead to quadriceps tightness, reduced knee range of motion, loss of muscle strength, pain, and impaired functional performance. Joint stiffness, muscle-tendon problems, contractures, and alterations in gait may also occur during femoral lengthening. Therefore, intensive and structured rehabilitation is an essential component of the treatment process.
Video feedback allows individuals to observe their own movement patterns, recognize movement errors, and modify their motor strategies. Although visual and video feedback approaches have demonstrated beneficial effects on gait and motor performance in several patient populations, their effects have not been investigated in individuals undergoing cosmetic bilateral femoral lengthening.
This study is designed as a prospective, parallel-group, assessor-blinded randomized controlled trial. A total of 32 participants aged 18-45 years who undergo cosmetic bilateral femoral lengthening using the LON technique will be assigned to two groups through computer-generated block randomization at a 1:1 ratio.
Both groups will participate in rehabilitation sessions 5 days per week, with each session lasting 50 minutes. The control group will receive 50 minutes of conventional physiotherapy. The intervention group will receive 40 minutes of conventional physiotherapy in addition to 10 minutes of video feedback-supported gait training. Conventional physiotherapy will include active and passive range-of-motion exercises, stretching exercises for the quadriceps and hamstring muscles, isometric strengthening exercises, gait training, and neuromuscular electrical stimulation.
During video feedback-supported gait training, participants will be recorded while walking along a 10-meter walkway. Recordings will be obtained in the frontal and sagittal planes. Participants will review their gait videos with the physiotherapist and receive standardized verbal and visual feedback regarding step width, step symmetry, lateral trunk deviation, shoulder alignment, pelvic position, Trendelenburg sign, hip and knee movements, foot contact, and gait rhythm.
Assessments will be conducted before surgery (T0), at approximately 4 cm of lengthening (T1), at approximately 8 cm of lengthening (T2), and 2 weeks after external fixator removal (T3). All assessments will be performed by an outcome assessor who is blinded to group allocation.
The primary outcome will be walking performance measured using the 10-Meter Walk Test. Secondary outcomes will include the Lower Extremity Functional Scale, Tampa Scale for Kinesiophobia, Body Awareness Questionnaire, quadriceps muscle strength measured with a handheld dynamometer, and pressure pain threshold measured with a pressure algometer.
The study will determine whether adding video feedback-supported gait training to conventional physiotherapy provides greater improvements in walking performance, functional status, movement-related fear, body awareness, quadriceps muscle strength, and pressure pain threshold than conventional physiotherapy alone.
- Conditions
- Bone Lengthening, Gait Disorders
- Being tested
- Video Feedback-Supported Gait Training, Conventional Physiotherapy
- Keywords
- Cosmetic Limb Lengthening, Bilateral Femoral Lengthening, Lengthening Over Nail, Video Feedback, Gait Training, Physical Therapy, Kinesiophobia, Body Awareness
- Medical subject headings
- Mobility Limitation, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Feedback-Supported Gait TrainingBehavioural
Participants will be recorded while walking on a 10-meter walkway in the frontal and sagittal planes. They will review the recordings with the physiotherapist and receive standardized visual and verbal feedback regarding step width, step symmetry, trunk alignment, pelvic position, Trendelenburg sign, lower-extremity movements, foot contact, and gait rhythm. The intervention will be administered for 10 minutes per session, 5 days per week throughout the distraction phase.
Conventional PhysiotherapyOther
Conventional physiotherapy will include active and passive range-of-motion exercises, quadriceps and hamstring stretching, isometric strengthening exercises, gait training, and neuromuscular electrical stimulation. The experimental arm will receive 40 minutes and the active comparator arm will receive 50 minutes per session, 5 days per week throughout the distraction phase.
| Study group | Role | What they receive |
|---|---|---|
| Video Feedback-Supported Rehabilitation | Experimental | Participants will receive 40 minutes of conventional physiotherapy and 10 minutes of video feedback-supported gait training per session, 5 days per week throughout the distraction phase. Receives: Behavioral: Video Feedback-Supported Gait Training; Other: Conventional Physiotherapy |
| Conventional Physiotherapy | Active comparator | Participants will receive 50 minutes of conventional physiotherapy per session, 5 days per week throughout the distraction phase. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Walking Speed Assessed by the 10-Meter Walk Test
Walking speed will be assessed on a 14-meter walkway. The first 2 meters will be used for acceleration and the final 2 meters for deceleration. The time required to walk the middle 10 meters at a comfortable speed will be recorded in seconds using a digital stopwatch. Walking speed will be calculated in meters per second. The test will be performed twice, and the mean value will be used. Higher walking speed indicates better walking performance.
Measured: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
Secondary outcomes (5)
Lower-Extremity Function
The Lower Extremity Functional Scale consists of 20 items assessing difficulty in performing daily activities. Each item is scored from 0 to 4, producing a total score ranging from 0 to 80. Higher scores indicate better lower-extremity function.
Measured: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
Change in Kinesiophobia Assessed With the Tampa Scale for Kinesiophobia
The Tampa Scale for Kinesiophobia is a 17-item self-reported questionnaire assessing fear of movement and reinjury. The total score ranges from 17 to 68. Higher scores indicate greater kinesiophobia.
Measured: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
Change in Body Awareness Assessed With the Body Awareness Questionnaire
The Body Awareness Questionnaire is an 18-item self-reported questionnaire assessing attentiveness to normal bodily processes and changes. The total score ranges from 18 to 126. Higher scores indicate greater body awareness.
Measured: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
Change in Quadriceps Muscle Strength Assessed With a Handheld Dynamometer
Quadriceps muscle strength will be measured using a MicroFET 2 handheld dynamometer. Participants will be assessed in a seated position with the hip and knee flexed to 90 degrees. Three measurements will be performed, and the mean value will be used. Higher values indicate greater quadriceps muscle strength.
Measured: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
Change in Pressure Pain Threshold Assessed With a Pressure Algometer
Pressure pain threshold will be measured over the vastus lateralis using a Baseline dolorimeter. The measurement point will be the midpoint between the greater trochanter and the lateral femoral condyle. Three measurements will be performed, and the mean value in kilograms per square centimeter will be used. Higher values indicate a higher pressure pain threshold and lower pressure sensitivity.
Measured: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion25 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LengtheningStudies 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
- A total of 32 participants will be randomly assigned in a 1:1 ratio to either the video feedback-supported rehabilitation group or the conventional physiotherapy group, with 16 participants in each arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FATMA ÇAVDARCI, Istanbul Aydın University
- Investigators
- Ioakim Ipseftel, PhD, Principal investigator, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731022
- Sponsor's protocol ID
- IAU-FTR-LON-VFB-01
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 28 Jul 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 shared because participant consent for external data sharing was not obtained.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Video Feedback-Supported Rehabilitation on Functional Outcomes in Individuals Undergoing Cosmetic Bilateral Femoral Lengthening: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07731022
- Acronym / sponsor ID
- IAU-FTR-LON-VFB-01
- Conditions
- Bone Lengthening, Gait Disorders
- Keywords
- Cosmetic Limb Lengthening, Bilateral Femoral Lengthening, Lengthening Over Nail, Video Feedback, Gait Training, Physical Therapy, Kinesiophobia, Body Awareness
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 25 Nov 2026 (estimated)
- First posted
- 28 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.
This randomized controlled study aims to investigate the effects of adding video feedback-supported gait training to a standard rehabilitation program in individuals undergoing cosmetic bilateral femoral lengthening surgery.
A total of 32 adults aged 18-45 years who undergo cosmetic bilateral femoral lengthening using the Lengthening Over Nail (LON) technique will be included. All surgical procedures will be performed at Private Esencan Hospital. Participants will be monitored at the hospital for the first 6 postoperative days, and the distraction phase will begin on postoperative day 7. After discharge, rehabilitation will continue at BNB Health Services and Consultancy Center.
Participants will be assigned to an intervention group or a control group using block randomization at a 1:1 ratio. Both groups will receive rehabilitation 5 days per week, with each session lasting 50 minutes. The control group will receive 50 minutes of conventional physiotherapy. The intervention group will receive 40 minutes of conventional physiotherapy and 10 minutes of video feedback-supported gait training.
Assessments will be performed before surgery (T0), when approximately 4 cm of lengthening has been achieved (T1), when approximately 8 cm of lengthening has been achieved (T2), and 2 weeks after removal of the external fixator (T3).
The primary outcome will be walking performance assessed using the 10-Meter Walk Test. Secondary outcomes will include lower-extremity function, kinesiophobia, body awareness, quadriceps muscle strength, and pressure pain threshold.
Detailed description
Cosmetic limb-lengthening surgery has become increasingly common among individuals seeking an increase in height. The Lengthening Over Nail (LON) technique reduces the duration of external fixation and provides greater mechanical stability. However, the lengthening process affects not only bone tissue but also muscles, tendons, connective tissues, blood vessels, and the nervous system.
During distraction osteogenesis, approximately 1 mm of lengthening is generally performed each day. The resulting continuous mechanical tension on the soft tissues may lead to quadriceps tightness, reduced knee range of motion, loss of muscle strength, pain, and impaired functional performance. Joint stiffness, muscle-tendon problems, contractures, and alterations in gait may also occur during femoral lengthening. Therefore, intensive and structured rehabilitation is an essential component of the treatment process.
Video feedback allows individuals to observe their own movement patterns, recognize movement errors, and modify their motor strategies. Although visual and video feedback approaches have demonstrated beneficial effects on gait and motor performance in several patient populations, their effects have not been investigated in individuals undergoing cosmetic bilateral femoral lengthening.
This study is designed as a prospective, parallel-group, assessor-blinded randomized controlled trial. A total of 32 participants aged 18-45 years who undergo cosmetic bilateral femoral lengthening using the LON technique will be assigned to two groups through computer-generated block randomization at a 1:1 ratio.
Both groups will participate in rehabilitation sessions 5 days per week, with each session lasting 50 minutes. The control group will receive 50 minutes of conventional physiotherapy. The intervention group will receive 40 minutes of conventional physiotherapy in addition to 10 minutes of video feedback-supported gait training. Conventional physiotherapy will include active and passive range-of-motion exercises, stretching exercises for the quadriceps and hamstring muscles, isometric strengthening exercises, gait training, and neuromuscular electrical stimulation.
During video feedback-supported gait training, participants will be recorded while walking along a 10-meter walkway. Recordings will be obtained in the frontal and sagittal planes. Participants will review their gait videos with the physiotherapist and receive standardized verbal and visual feedback regarding step width, step symmetry, lateral trunk deviation, shoulder alignment, pelvic position, Trendelenburg sign, hip and knee movements, foot contact, and gait rhythm.
Assessments will be conducted before surgery (T0), at approximately 4 cm of lengthening (T1), at approximately 8 cm of lengthening (T2), and 2 weeks after external fixator removal (T3). All assessments will be performed by an outcome assessor who is blinded to group allocation.
The primary outcome will be walking performance measured using the 10-Meter Walk Test. Secondary outcomes will include the Lower Extremity Functional Scale, Tampa Scale for Kinesiophobia, Body Awareness Questionnaire, quadriceps muscle strength measured with a handheld dynamometer, and pressure pain threshold measured with a pressure algometer.
The study will determine whether adding video feedback-supported gait training to conventional physiotherapy provides greater improvements in walking performance, functional status, movement-related fear, body awareness, quadriceps muscle strength, and pressure pain threshold than conventional physiotherapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 32 participants will be randomly assigned in a 1:1 ratio to either the video feedback-supported rehabilitation group or the conventional physiotherapy group, with 16 participants in each arm.
| Arm | Type | Receives |
|---|---|---|
| Video Feedback-Supported Rehabilitation | Experimental | Behavioral: Video Feedback-Supported Gait Training, Other: Conventional PhysiotherapyParticipants will receive 40 minutes of conventional physiotherapy and 10 minutes of video feedback-supported gait training per session, 5 days per week throughout the distraction phase. |
| Conventional Physiotherapy | Active comparator | Other: Conventional PhysiotherapyParticipants will receive 50 minutes of conventional physiotherapy per session, 5 days per week throughout the distraction phase. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged between 18 and 45 years
- Scheduled to undergo cosmetic bilateral femoral lengthening surgery using the Lengthening Over Nail technique
- Able and willing to participate regularly in the preoperative and postoperative assessments and rehabilitation program
- Able to understand the study procedures and follow the physiotherapist's instructions
- Willing to provide written informed consent
Key exclusion criteria (7 listed)
- - Presence of a congenital, neurological, or rheumatological disorder
- Previous major orthopedic surgery affecting the lower extremities
- Presence of cerebral palsy, muscular dystrophy, peripheral neuropathy, or another neuromuscular disorder
- Advanced deformity, contracture, or osteoarthritis affecting the hip, knee, or ankle
- Psychiatric illness or cognitive impairment that may affect participation or adherence
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 |
|---|---|---|
| Video Feedback-Supported Gait TrainingParticipants will be recorded while walking on a 10-meter walkway in the frontal and sagittal planes. They will review the recordings with the physiotherapist and receive standardized visual and verbal feedback regarding step width, step symmetry, trunk alignment, pelvic position, Trendelenburg sign, lower-extremity movements, foot contact, and gait rhythm. The intervention will be administered for 10 minutes per session, 5 days per week throughout the distraction phase. | Behavioural | Video Feedback-Supported Rehabilitation |
| Conventional PhysiotherapyConventional physiotherapy will include active and passive range-of-motion exercises, quadriceps and hamstring stretching, isometric strengthening exercises, gait training, and neuromuscular electrical stimulation. The experimental arm will receive 40 minutes and the active comparator arm will receive 50 minutes per session, 5 days per week throughout the distraction phase. | Other | Conventional Physiotherapy, Video Feedback-Supported Rehabilitation |
Primary outcome
Change in Walking Speed Assessed by the 10-Meter Walk Test
Time frame: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
Walking speed will be assessed on a 14-meter walkway. The first 2 meters will be used for acceleration and the final 2 meters for deceleration. The time required to walk the middle 10 meters at a comfortable speed will be recorded in seconds using a digital stopwatch. Walking speed will be calculated in meters per second. The test will be performed twice, and the mean value will be used. Higher walking speed indicates better walking performance.
5 secondary outcomes
Lower-Extremity Function
Time frame: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
Change in Kinesiophobia Assessed With the Tampa Scale for Kinesiophobia
Time frame: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
Change in Body Awareness Assessed With the Body Awareness Questionnaire
Time frame: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
Change in Quadriceps Muscle Strength Assessed With a Handheld Dynamometer
Time frame: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
Change in Pressure Pain Threshold Assessed With a Pressure Algometer
Time frame: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.
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 28 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because participant consent for external data sharing was not obtained.
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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.
Ioakim Ipseftel, PhD principal investigator
Istanbul Aydın 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 Video Feedback-Supported Gait Training and Conventional Physiotherapy in people with Bone Lengthening and Gait Disorders, run by Istanbul Aydın University 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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 28 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 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?
Contact Fatma Çavdarcı, PhD Candidate, Physiotherapy (+905374590918, cvdrcftm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Walking Speed Assessed by the 10-Meter Walk Test (time frame: Baseline (preoperative), postoperative Week 7, postoperative Week 13, and postoperative Week 15.). 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 28 Jul 2026.