Gait Disorders, NeurologicNCT06461923
Home-based Gait Rehabilitation Service Using the Insole-type Gait Analysis Device for Children With Cerebral Palsy
A study testing Insole wearing in people with Gait Disorders, Neurologic and Cerebral Palsy, run by Yonsei University at 1 site in South Korea.
Trial summary
Walking is a crucial daily activity that requires complex coordination of muscular systems. It is essential for bone and muscle health, cardiovascular fitness, and activities of daily living, making it an important indicator of prognosis and patient function. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Gait Disorders, Neurologic, Cerebral Palsy
- What is being tested?
- Insole wearing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2024to Jun 2025
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients diagnosed with cerebral palsy aged 7 to 18 years old
- Patients classified as Gross Motor Function Classification System level 1 or 2
- Individuals who visited Severance Hospital, comprehended the study, agreed to participate, and submitted the informed consent form
Who cannot join
- Individuals with complications such as severe foot deformities where the sensors of the insole gait analysis device cannot be recognized
- In addition to above, individuals with clinically significant findings deemed inappropriate for this study by the study director or person in charge based on medical judgment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, Seodaemun-gu, 03722
Juntaek Hong, +82 010 6517 7526, GHDWNSXOR@yuhs.ac
Yerim Do, +82 010 7154 6011, doyr62@gmail.com
About this study
Official title: Development and Feasibility Study of the Home-based Gait Rehabilitation Service by Using the Insole-type Gait Analysis Device for Children With Cerebral Palsy
Walking is a crucial daily activity that requires complex coordination of muscular systems. It is essential for bone and muscle health, cardiovascular fitness, and activities of daily living, making it an important indicator of prognosis and patient function. Insole gait analysis devices are affordable and easy to use, and they align well with standardized 3D gait analysis. However, their use outside of hospital settings is limited.
This study aims to assess the usability and satisfaction of utilizing insole gait analysis devices for monitoring and providing feedback on the walking status of children with cerebral palsy exhibiting walking impairments in a home environment. Additionally, adherence to a home-based exercise program developed in this study will be evaluated.
Read the detailed description
The screening test is conducted after obtaining consent, and it involves assessing whether the subject can independently walk more than 10 meters, regardless of the use of assistive devices, following an evaluation of their baseline symptoms and signs.
Subjects who pass the screening test are provided with information about their current walking status and what constitutes normal walking. Following the initial evaluation, they are instructed to participate in the 6-week home exercise program and how to record an exercise log. Additionally, researchers provide participants with an insole gait analysis device and instruct them on its operation, encouraging prolonged usage to ensure that usage time and walking patterns are recorded.
Based on the collected measurement data, feedback is provided over the phone at weeks 3 to 4. After completing the 6-week home exercise program, a final evaluation is conducted in the same manner as the initial evaluation. Satisfaction with the insole gait analysis device is assessed only at the time of the final evaluation.
Usage and satisfaction with the insole gait analysis device will be analyzed, and evaluation indicators will be compared before and after the home exercise program. Additionally, adherence to the home exercise program will be evaluated through exercise logs.
- Conditions
- Gait Disorders, Neurologic, Cerebral Palsy
- Being tested
- Insole wearing
- Keywords
- gait parameters, smart insole, home-based exercise, monitoring system, rehabilitation
- Medical subject headings
- Gait Disorders, Neurologic, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insole wearingDevice
The insole-wearing group is instructed to wear the insole gait analysis device as frequently and for as long as possible during outdoor activities. Participants receive feedback during 3rd to 4th week via telephone. Following a period of 6 weeks, an evaluation of the usability and satisfaction of the insole gait analysis device will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| Insole wearing | Experimental | Not described Receives: Device: Insole wearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute Walking Test
Measured: This test results will be assessed two times: baseline and after 6 weeks
Secondary outcomes (18)
Appendicular muscle mass (kg)
This outcome will be measured using bioelectrical impedance.
Measured: This test results will be assessed two times: baseline and after 6 weeks
Height (cm)
This outcome will be measured using bioelectrical impedance.
Measured: This test results will be assessed two times: baseline and after 6 weeks
Weight (kg)
This outcome will be measured using bioelectrical impedance.
Measured: This test results will be assessed two times: baseline and after 6 weeks
Grip Strength Test (kg)
Measured: This test results will be assessed two times: baseline and after 6 weeks
The number of steps (n)
This outcome will be collected using an insole-type gait analyzer.
Measured: This test results will be assessed two times: baseline and after 6 weeks
Calories burned (kcal)
This outcome will be collected using an insole-type gait analyzer.
Measured: This test results will be assessed two times: baseline and after 6 weeks
Activity time (min)
This outcome will be collected using an insole-type gait analyzer.
Measured: This test results will be assessed two times: baseline and after 6 weeks
Activity distance (km)
This outcome will be collected using an insole-type gait analyzer.
Measured: This test results will be assessed two times: baseline and after 6 weeks
Walking speed (m/s)
This outcome will be collected using an insole-type gait analyzer.
Measured: This test results will be assessed two times: baseline and after 6 weeks
Stride length (cm)
This outcome will be collected using an insole-type gait analyzer.
Measured: This test results will be assessed two times: baseline and after 6 weeks
Left-right gait balance (%)
This outcome will be collected using an insole-type gait analyzer.
Measured: This test results will be assessed two times: baseline and after 6 weeks
10-meter Walking Test (m/s)
Measured: This test results will be assessed two times: baseline and after 6 weeks
Pediatric Balance Scale (scores)
The minimum score is 0 points, and the maximum score is 56 points. A higher score indicates better balance ability in children and a greater capacity to perform daily activities independently.
Measured: This test results will be assessed two times: baseline and after 6 weeks
Gross Motor Function Classification System (levels)
Measured: This test results will be assessed two times: baseline and after 6 weeks
Korean version of Cerebral Palsy Quality of Life (scores)
If the participant is aged 8 or younger, the relevant questionnaire will be administered; otherwise, the Korean version of KIDSCREEN-52 will be used.
The minimum score is 0 points, and the maximum score is 100 points. A higher score indicates a higher quality of life.
Measured: This test results will be assessed two times: baseline and after 6 weeks
Korean version of KIDSCREEN-52 (Children & Adolescents) (scores)
If the participant is aged over 8, the relevant questionnaire will be administered.
The minimum score is 52 points, and the maximum score is 260 points. A higher score indicates a higher quality of life.
Measured: This test results will be assessed two times: baseline and after 6 weeks
Korean version of KIDSCREEN-52 (Parents) (scores)
The minimum score is 52 points, and the maximum score is 260 points. A higher score indicates a higher quality of life.
Measured: This test results will be assessed two times: baseline and after 6 weeks
Satisfaction Survey for the Device (scores)
The minimum score is 12, and the maximum score is 84 points. A higher score indicates lower satisfaction.
Measured: This test results will be assessed once: after 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Aug 2024
- Primary completionMay 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Gait Disorders, NeurologicStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Responsible party
- Sponsor
- Investigators
- Na Young Kim, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461923
- Sponsor's protocol ID
- 4-2023-1407
- Status last verified
- Feb 2025
- First submitted
- 28 May 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salzman B. Gait and balance disorders in older adults. Am Fam Physician. 2010 Jul 1;82(1):61-8.
PubMed 20590073Fritz S, Lusardi M. White paper: "walking speed: the sixth vital sign". J Geriatr Phys Ther. 2009;32(2):46-9. No abstract available.
PubMed 20039582Middleton A, Fritz SL, Lusardi M. Walking speed: the functional vital sign. J Aging Phys Act. 2015 Apr;23(2):314-22. doi: 10.1123/japa.2013-0236. Epub 2014 May 2.
PubMed 24812254Stolze H, Klebe S, Baecker C, Zechlin C, Friege L, Pohle S, Deuschl G. Prevalence of gait disorders in hospitalized neurological patients. Mov Disord. 2005 Jan;20(1):89-94. doi: 10.1002/mds.20266.
PubMed 15390043Giladi N, Horak FB, Hausdorff JM. Classification of gait disturbances: distinguishing between continuous and episodic changes. Mov Disord. 2013 Sep 15;28(11):1469-73. doi: 10.1002/mds.25672.
PubMed 24132835Carlon SL, Taylor NF, Dodd KJ, Shields N. Differences in habitual physical activity levels of young people with cerebral palsy and their typically developing peers: a systematic review. Disabil Rehabil. 2013 Apr;35(8):647-55. doi: 10.3109/09638288.2012.715721. Epub 2012 Oct 17.
PubMed 23072296Waltersson L, Rodby-Bousquet E. Physical Activity in Adolescents and Young Adults with Cerebral Palsy. Biomed Res Int. 2017;2017:8080473. doi: 10.1155/2017/8080473. Epub 2017 Dec 20.
PubMed 29423412O'Connell NE, Smith KJ, Peterson MD, Ryan N, Liverani S, Anokye N, Victor C, Ryan JM. Incidence of osteoarthritis, osteoporosis and inflammatory musculoskeletal diseases in adults with cerebral palsy: A population-based cohort study. Bone. 2019 Aug;125:30-35. doi: 10.1016/j.bone.2019.05.007. Epub 2019 May 8.
PubMed 31075418Mcphee PG, Claridge EA, Noorduyn SG, Gorter JW. Cardiovascular disease and related risk factors in adults with cerebral palsy: a systematic review. Dev Med Child Neurol. 2019 Aug;61(8):915-923. doi: 10.1111/dmcn.14028. Epub 2018 Sep 17.
PubMed 30221763Bulekbayeva S, Daribayev Z, Ospanova S, Vento S. Cerebral palsy: a multidisciplinary, integrated approach is essential. Lancet Glob Health. 2017 Apr;5(4):e401. doi: 10.1016/S2214-109X(17)30082-7. No abstract available.
PubMed 28288745Muro-de-la-Herran A, Garcia-Zapirain B, Mendez-Zorrilla A. Gait analysis methods: an overview of wearable and non-wearable systems, highlighting clinical applications. Sensors (Basel). 2014 Feb 19;14(2):3362-94. doi: 10.3390/s140203362.
PubMed 24556672Ngueleu AM, Blanchette AK, Maltais D, Moffet H, McFadyen BJ, Bouyer L, Batcho CS. Validity of Instrumented Insoles for Step Counting, Posture and Activity Recognition: A Systematic Review. Sensors (Basel). 2019 May 28;19(11):2438. doi: 10.3390/s19112438.
PubMed 31141973Andreoli A, Garaci F, Cafarelli FP, Guglielmi G. Body composition in clinical practice. Eur J Radiol. 2016 Aug;85(8):1461-8. doi: 10.1016/j.ejrad.2016.02.005. Epub 2016 Feb 15.
PubMed 26971404Lee SY. Handgrip Strength: An Irreplaceable Indicator of Muscle Function. Ann Rehabil Med. 2021 Jun;45(3):167-169. doi: 10.5535/arm.21106. Epub 2021 Jun 30. No abstract available.
PubMed 34233405Chrysagis N, Skordilis EK, Koutsouki D. Validity and clinical utility of functional assessments in children with cerebral palsy. Arch Phys Med Rehabil. 2014 Feb;95(2):369-74. doi: 10.1016/j.apmr.2013.10.025. Epub 2013 Nov 12.
PubMed 24239880
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility Study of the Home-based Gait Rehabilitation Service by Using the Insole-type Gait Analysis Device for Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06461923
- Acronym / sponsor ID
- 4-2023-1407
- Conditions
- Gait Disorders, Neurologic, Cerebral Palsy
- Keywords
- gait parameters, smart insole, home-based exercise, monitoring system, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 17 Jun 2024 (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.
Walking is a crucial daily activity that requires complex coordination of muscular systems. It is essential for bone and muscle health, cardiovascular fitness, and activities of daily living, making it an important indicator of prognosis and patient function. Insole gait analysis devices are affordable and easy to use, and they align well with standardized 3D gait analysis. However, their use outside of hospital settings is limited.
This study aims to assess the usability and satisfaction of utilizing insole gait analysis devices for monitoring and providing feedback on the walking status of children with cerebral palsy exhibiting walking impairments in a home environment. Additionally, adherence to a home-based exercise program developed in this study will be evaluated.
Detailed description
The screening test is conducted after obtaining consent, and it involves assessing whether the subject can independently walk more than 10 meters, regardless of the use of assistive devices, following an evaluation of their baseline symptoms and signs.
Subjects who pass the screening test are provided with information about their current walking status and what constitutes normal walking. Following the initial evaluation, they are instructed to participate in the 6-week home exercise program and how to record an exercise log. Additionally, researchers provide participants with an insole gait analysis device and instruct them on its operation, encouraging prolonged usage to ensure that usage time and walking patterns are recorded.
Based on the collected measurement data, feedback is provided over the phone at weeks 3 to 4. After completing the 6-week home exercise program, a final evaluation is conducted in the same manner as the initial evaluation. Satisfaction with the insole gait analysis device is assessed only at the time of the final evaluation.
Usage and satisfaction with the insole gait analysis device will be analyzed, and evaluation indicators will be compared before and after the home exercise program. Additionally, adherence to the home exercise program will be evaluated through exercise logs.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insole wearing | Experimental | Device: Insole wearing |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients diagnosed with cerebral palsy aged 7 to 18 years old
- Patients classified as Gross Motor Function Classification System level 1 or 2
- Individuals who visited Severance Hospital, comprehended the study, agreed to participate, and submitted the informed consent form
Key exclusion criteria (2 listed)
- Individuals with complications such as severe foot deformities where the sensors of the insole gait analysis device cannot be recognized
- In addition to above, individuals with clinically significant findings deemed inappropriate for this study by the study director or person in charge based on medical judgment
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 |
|---|---|---|
| Insole wearingThe insole-wearing group is instructed to wear the insole gait analysis device as frequently and for as long as possible during outdoor activities. Participants receive feedback during 3rd to 4th week via telephone. Following a period of 6 weeks, an evaluation of the usability and satisfaction of the insole gait analysis device will be conducted. | Device | Insole wearing |
Primary outcome
6-minute Walking Test
Time frame: This test results will be assessed two times: baseline and after 6 weeks
18 secondary outcomes
Appendicular muscle mass (kg)
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Height (cm)
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Weight (kg)
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Grip Strength Test (kg)
Time frame: This test results will be assessed two times: baseline and after 6 weeks
The number of steps (n)
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Calories burned (kcal)
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Activity time (min)
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Activity distance (km)
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Walking speed (m/s)
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Stride length (cm)
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Left-right gait balance (%)
Time frame: This test results will be assessed two times: baseline and after 6 weeks
10-meter Walking Test (m/s)
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Pediatric Balance Scale (scores)
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Gross Motor Function Classification System (levels)
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Korean version of Cerebral Palsy Quality of Life (scores)
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Korean version of KIDSCREEN-52 (Children & Adolescents) (scores)
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Korean version of KIDSCREEN-52 (Parents) (scores)
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Satisfaction Survey for the Device (scores)
Time frame: This test results will be assessed once: after 6 weeks
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 10 Feb 2025.
- Results publication: PubMed 20590073Salzman B. Gait and balance disorders in older adults. Am Fam Physician. 2010 Jul 1;82(1):61-8.
- Results publication: PubMed 20039582Fritz S, Lusardi M. White paper: "walking speed: the sixth vital sign". J Geriatr Phys Ther. 2009;32(2):46-9. No abstract available.
- Results publication: PubMed 24812254Middleton A, Fritz SL, Lusardi M. Walking speed: the functional vital sign. J Aging Phys Act. 2015 Apr;23(2):314-22. doi: 10.1123/japa.2013-0236. Epub 2014 May 2.
- Results publication: PubMed 15390043Stolze H, Klebe S, Baecker C, Zechlin C, Friege L, Pohle S, Deuschl G. Prevalence of gait disorders in hospitalized neurological patients. Mov Disord. 2005 Jan;20(1):89-94. doi: 10.1002/mds.20266.
- Results publication: PubMed 24132835Giladi N, Horak FB, Hausdorff JM. Classification of gait disturbances: distinguishing between continuous and episodic changes. Mov Disord. 2013 Sep 15;28(11):1469-73. doi: 10.1002/mds.25672.
- Results publication: PubMed 23072296Carlon SL, Taylor NF, Dodd KJ, Shields N. Differences in habitual physical activity levels of young people with cerebral palsy and their typically developing peers: a systematic review. Disabil Rehabil. 2013 Apr;35(8):647-55. doi: 10.3109/09638288.2012.715721. Epub 2012 Oct 17.
- Results publication: PubMed 29423412Waltersson L, Rodby-Bousquet E. Physical Activity in Adolescents and Young Adults with Cerebral Palsy. Biomed Res Int. 2017;2017:8080473. doi: 10.1155/2017/8080473. Epub 2017 Dec 20.
- Results publication: PubMed 31075418O'Connell NE, Smith KJ, Peterson MD, Ryan N, Liverani S, Anokye N, Victor C, Ryan JM. Incidence of osteoarthritis, osteoporosis and inflammatory musculoskeletal diseases in adults with cerebral palsy: A population-based cohort study. Bone. 2019 Aug;125:30-35. doi: 10.1016/j.bone.2019.05.007. Epub 2019 May 8.
- Results publication: PubMed 30221763Mcphee PG, Claridge EA, Noorduyn SG, Gorter JW. Cardiovascular disease and related risk factors in adults with cerebral palsy: a systematic review. Dev Med Child Neurol. 2019 Aug;61(8):915-923. doi: 10.1111/dmcn.14028. Epub 2018 Sep 17.
- Results publication: PubMed 28288745Bulekbayeva S, Daribayev Z, Ospanova S, Vento S. Cerebral palsy: a multidisciplinary, integrated approach is essential. Lancet Glob Health. 2017 Apr;5(4):e401. doi: 10.1016/S2214-109X(17)30082-7. No abstract available.
- Results publication: PubMed 24556672Muro-de-la-Herran A, Garcia-Zapirain B, Mendez-Zorrilla A. Gait analysis methods: an overview of wearable and non-wearable systems, highlighting clinical applications. Sensors (Basel). 2014 Feb 19;14(2):3362-94. doi: 10.3390/s140203362.
- Results publication: PubMed 31141973Ngueleu AM, Blanchette AK, Maltais D, Moffet H, McFadyen BJ, Bouyer L, Batcho CS. Validity of Instrumented Insoles for Step Counting, Posture and Activity Recognition: A Systematic Review. Sensors (Basel). 2019 May 28;19(11):2438. doi: 10.3390/s19112438.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Na Young Kim principal investigator
Severance 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 Insole wearing in people with Gait Disorders, Neurologic and Cerebral Palsy, run by Yonsei University at 1 site in South Korea.
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 2 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: looking for participants now, as of the sponsor's last update on 10 Feb 2025. 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 South Korea. 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 Juntaek Hong (+82 010 6517 7526, GHDWNSXOR@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute Walking Test (time frame: This test results will be assessed two times: baseline and after 6 weeks). 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 NCT06461923, which also lists 15 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 10 Feb 2025.