StrokeNCT06979934
Effect of 3D Printing Functional Hand Splints for Patients With Stroke
A study testing 3D printing splint group and functional splint group in people with Stroke, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
The study is to evaluate the effect of 3D printing functional splints on hand function for patients with stroke.Twenty stroke patients with moderate motor deficits were recruited and randomized into experimental (3D printing splint) or control (functional splint) groups for 8 weeks of treatment.The performance was… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- 3D printing splint group and functional splint group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2021to 30 Sep 2022
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cerebral stroke, patients with unilateral hemiplegia
- Onset is more than three months;
- Able to understand activity instructions;
- Fugl-Meyer assessment 20-50 points
Who cannot join
- Age over 75 years and under 20 years old;
- Other medical diseases that affect the execution program
- Modified Ashworth Scale of Wrist and hand greater than 2 Points
- Deformed elbow, wrist and hand joints
- Treated with botulinum toxin on the upper limbs of the affected side.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of 3D Printing Functional Splints on Hand Function for Patients With Stroke
The study is to evaluate the effect of 3D printing functional splints on hand function for patients with stroke.Twenty stroke patients with moderate motor deficits were recruited and randomized into experimental (3D printing splint) or control (functional splint) groups for 8 weeks of treatment.The performance was assessed by a blinded assessor for two times including motor, function, and feasibility.Collected data will be analyzed with nonparametric tests by SPSS version 20.0, and alpha level was set at .05.
Read the detailed description
Background: Spasticity is an important factor limiting independency and activity of daily living for post-stroke patients. Splinting has been proved to be successful treatment for spasticity.3D printing technology was used to construct personalized, complicated orthosis, and one piece to reduce assembly time. The evidence most are product development, but few of study investigate the effectiveness.
Aim: To evaluate the effect of 3D printing functional splints on hand function for patients with stroke.
Methods: Twenty stroke patients with moderate motor deficits were recruited and randomized into experimental (3D printing splint) or control (functional splint) groups for 8 weeks of treatment (Sixty minutes for position and twenty minutes for training a time, triple times a day). The performance was assessed by a blinded assessor for two times included Fugl-Meyer Assessment-Upper Limb section(FMA-UE), Electromyography (EMG), Grip dynamometer, Passive Range of motion (PROM) at upper extremity, Muscle tone at upper extremity, and Disability of the arm, shoulder and hand questionnaire(DASH). The splint wearing performance and Satisfaction were recorded. Collected data will be analyzed with nonparametric tests by SPSS version 20.0, and alpha level was set at .05.
- Conditions
- Stroke
- Being tested
- 3D printing splint group, functional splint group
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printing splint groupBehavioural
Wear 3D printing design splint for position for 60 minutes each time, plus 20 minutes of exercise which including:(1) Raise hands for 5 minutes, and bend and straighten the elbow for 5 minutes for proximal movement exercise;(2) Wear 3D printed design hand splint and change objects according to the ability of grasp, such as hold a cup, handle, eraser, pen, etc.
functional splint groupBehavioural
Wear functional splint for position for 60 minutes each time, plus 20 minutes of exercise which including:(1) Raise hands for 5 minutes, and bend and straighten the elbow for 5 minutes for proximal movement exercise;(2) Grasp the holder according the grasp ability, such as hold a cup, handle, eraser, pen, etc.
| Study group | Role | What they receive |
|---|---|---|
| 3D printing splint group | Experimental | 3D printing splint for 8 weeks of treatment (Sixty minutes for position and twenty minutes for training a time, triple times a day) Receives: Behavioral: 3D printing splint group |
| functional splint group | Active comparator | functional splint for 8 weeks of treatment (Sixty minutes for position and twenty minutes for training a time, triple times a day) Receives: Behavioral: functional splint group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment-upper extremity
The Fugl-Meyer Assessment-upper extremity (FMA-UE) measures motor impairment in the upper extremity. The assessment consists of 33 items, including movement, reflex, grasp, and coordination, and a total score of 66.The unit of measure is score.
Measured: Change from Baseline at 8 weeks
Secondary outcomes (7)
Electromyography
Record the maximum voluntary contraction (maximal voluntary contraction; MVC) of the wrist extensor muscles, total extensor muscles, and flexor muscles.The unit of measure is motor unit.
Measured: Change from Baseline at 8 weeks
Dynanometer
The grip dynamometer was used to measure the maximum isometric strength of the hand and forearm muscles. The mean score of 3 trials was calculated. For this measurement, the elbow was placed at 90° and the forearm was placed in mid-position.The unit of measure is kilograms.
Measured: Change from Baseline at 8 weeks
Range of motion of upper limb joints
Passive movement angle of elbow joint, wrist joint and thumb, finger metacarpophalangeal joint.The unit of measure is degree.
Measured: Change from Baseline at 8 weeks
Disabilities of The Arm, Shoulder And Hand Questionnaire
a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100. We used the subtest of Activity capacity, severity of illness.The unit of measure is score.
Measured: Change from Baseline at 8 weeks
Side effects record
The number of side effects after intervention (such as soreness, pain, motion vertigo, injury, etc.) were recorded every day. The unit of measure is number of times.
Measured: Every training session, total sessions continued to 8 weeks
Satisfaction questionnaire
The questionnaire is a subjective self-filling scale using a hand brace, with 5-level scores (strongly agree to strongly disagree), including aesthetics, complexity, weight, resistance, comfort, ease of wear, etc.The unit of measure is score.
Measured: Every training session, total sessions continued to 8 weeks
Wear performance record
The wear and exercise times were recorded every day. The unit of measure is number of times.
Measured: Every training session, total sessions continued to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Jul 2021 (estimated)
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Why it stopped: Because the project proposal was not approved for funding, it was not carried out.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsinchieh Lee, Principal investigator, Taipei Medical University, Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06979934
- Sponsor's protocol ID
- TMU-JIRB N202104007
- Status last verified
- May 2025
- First submitted
- 23 May 2021
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alexander J, Dawson J, Langhorne P. Dynamic hand orthoses for the recovery of hand and arm function in adults after stroke: A systematic review and meta-analysis of randomised controlled trials. Top Stroke Rehabil. 2022 Mar;29(2):114-124. doi: 10.1080/10749357.2021.1878669. Epub 2021 Jan 31.
PubMed 33517868Ates, S., Haarman, C. J., & Stienen, A. H. J. A. R. (2017). SCRIPT passive orthosis: design of interactive hand and wrist exoskeleton for rehabilitation at home after stroke. 41(3), 711-723.
Azeez, A., Gopichand, A., Shankar, N., Hanumantharao, K. J. I. J. o. E. T., & Technology. (2015). A novel prosthetic hand support for physically disabled. 29(6), 295-298
Baronio G, Harran S, Signoroni A. A Critical Analysis of a Hand Orthosis Reverse Engineering and 3D Printing Process. Appl Bionics Biomech. 2016;2016:8347478. doi: 10.1155/2016/8347478. Epub 2016 Aug 9.
PubMed 27594781Basteris A, Nijenhuis SM, Stienen AH, Buurke JH, Prange GB, Amirabdollahian F. Training modalities in robot-mediated upper limb rehabilitation in stroke: a framework for classification based on a systematic review. J Neuroeng Rehabil. 2014 Jul 10;11:111. doi: 10.1186/1743-0003-11-111.
PubMed 25012864Cazon, A., Aizpurua, J., Paterson, A., Bibb, R., Campbell, R. I. J. V., & Prototyping, P. (2014). Customised design and manufacture of protective face masks combining a practitioner-friendly modelling approach and low-cost devices for digitising and additive manufacturing: This paper analyses the viability of replacing conventional practice with AM method to make customized protective face masks. 9(4), 251-261.
Chang, K., Chang, J.-H., Huang, M.-W., & Lee, L.-Y. (2018). Innovative orthosis for phalanx extension neurofacilitation (iOPEN)-development of a 3D-printed hand orthosis for chronic stroke patient. Paper presented at the 2018 IEEE International Conference on Applied System Invention (ICASI).
Chang WD, Lai PT. New design of home-based dynamic hand splint for hemiplegic hands: a preliminary study. J Phys Ther Sci. 2015 Mar;27(3):829-31. doi: 10.1589/jpts.27.829. Epub 2015 Mar 31.
PubMed 25931740Copley J, Kuipers K, Fleming J, Rassafiani M. Individualised resting hand splints for adults with acquired brain injury: a randomized, single blinded, single case design. NeuroRehabilitation. 2013;32(4):885-98. doi: 10.3233/NRE-130913.
PubMed 23867415Diment LE, Thompson MS, Bergmann JH. Three-dimensional printed upper-limb prostheses lack randomised controlled trials: A systematic review. Prosthet Orthot Int. 2018 Feb;42(1):7-13. doi: 10.1177/0309364617704803. Epub 2017 Jun 24.
PubMed 28649911Duncan PW, Propst M, Nelson SG. Reliability of the Fugl-Meyer assessment of sensorimotor recovery following cerebrovascular accident. Phys Ther. 1983 Oct;63(10):1606-10. doi: 10.1093/ptj/63.10.1606.
PubMed 6622535Emzain, Z. F., Huang, S.-C., Yang, Y.-S., & Qosim, N. J. R. M. (2020). Design and Analysis of a Dynamic Splint Based on Pulley Rotation for Post-Stroke Finger Extension Rehabilitation Device. 11(3), 477-485.
Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. doi: 10.1016/s0140-6736(13)61953-4.
PubMed 24449944Fitzpatrick, A. P., Mohanned, M. I., Collins, P. K., & Gibson, I. J. K. E. (2017). Design of a patient specific, 3D printed arm cast. 135-142.
Gregson JM, Leathley M, Moore AP, Sharma AK, Smith TL, Watkins CL. Reliability of the Tone Assessment Scale and the modified Ashworth scale as clinical tools for assessing poststroke spasticity. Arch Phys Med Rehabil. 1999 Sep;80(9):1013-6. doi: 10.1016/s0003-9993(99)90053-9.
PubMed 10489001
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 3D Printing Functional Splints on Hand Function for Patients With Stroke
- ClinicalTrials.gov ID
- NCT06979934
- Acronym / sponsor ID
- TMU-JIRB N202104007
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because the project proposal was not approved for funding, it was not carried out.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 20 May 2025 (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.
The study is to evaluate the effect of 3D printing functional splints on hand function for patients with stroke.Twenty stroke patients with moderate motor deficits were recruited and randomized into experimental (3D printing splint) or control (functional splint) groups for 8 weeks of treatment.The performance was assessed by a blinded assessor for two times including motor, function, and feasibility.Collected data will be analyzed with nonparametric tests by SPSS version 20.0, and alpha level was set at .05.
Detailed description
Background: Spasticity is an important factor limiting independency and activity of daily living for post-stroke patients. Splinting has been proved to be successful treatment for spasticity.3D printing technology was used to construct personalized, complicated orthosis, and one piece to reduce assembly time. The evidence most are product development, but few of study investigate the effectiveness.
Aim: To evaluate the effect of 3D printing functional splints on hand function for patients with stroke.
Methods: Twenty stroke patients with moderate motor deficits were recruited and randomized into experimental (3D printing splint) or control (functional splint) groups for 8 weeks of treatment (Sixty minutes for position and twenty minutes for training a time, triple times a day). The performance was assessed by a blinded assessor for two times included Fugl-Meyer Assessment-Upper Limb section(FMA-UE), Electromyography (EMG), Grip dynamometer, Passive Range of motion (PROM) at upper extremity, Muscle tone at upper extremity, and Disability of the arm, shoulder and hand questionnaire(DASH). The splint wearing performance and Satisfaction were recorded. Collected data will be analyzed with nonparametric tests by SPSS version 20.0, and alpha level was set at .05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D printing splint group | Experimental | Behavioral: 3D printing splint group3D printing splint for 8 weeks of treatment (Sixty minutes for position and twenty minutes for training a time, triple times a day) |
| functional splint group | Active comparator | Behavioral: functional splint groupfunctional splint for 8 weeks of treatment (Sixty minutes for position and twenty minutes for training a time, triple times a day) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cerebral stroke, patients with unilateral hemiplegia
- Onset is more than three months;
- Able to understand activity instructions;
- Fugl-Meyer assessment 20-50 points
Key exclusion criteria (5 listed)
- Age over 75 years and under 20 years old;
- Other medical diseases that affect the execution program
- Modified Ashworth Scale of Wrist and hand greater than 2 Points
- Deformed elbow, wrist and hand joints
- Treated with botulinum toxin on the upper limbs of the affected side.
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 |
|---|---|---|
| 3D printing splint groupWear 3D printing design splint for position for 60 minutes each time, plus 20 minutes of exercise which including:(1) Raise hands for 5 minutes, and bend and straighten the elbow for 5 minutes for proximal movement exercise;(2) Wear 3D printed design hand splint and change objects according to the ability of grasp, such as hold a cup, handle, eraser, pen, etc. | Behavioural | 3D printing splint group |
| functional splint groupWear functional splint for position for 60 minutes each time, plus 20 minutes of exercise which including:(1) Raise hands for 5 minutes, and bend and straighten the elbow for 5 minutes for proximal movement exercise;(2) Grasp the holder according the grasp ability, such as hold a cup, handle, eraser, pen, etc. | Behavioural | functional splint group |
Primary outcome
Fugl-Meyer Assessment-upper extremity
Time frame: Change from Baseline at 8 weeks
The Fugl-Meyer Assessment-upper extremity (FMA-UE) measures motor impairment in the upper extremity. The assessment consists of 33 items, including movement, reflex, grasp, and coordination, and a total score of 66.The unit of measure is score.
7 secondary outcomes
Electromyography
Time frame: Change from Baseline at 8 weeks
Dynanometer
Time frame: Change from Baseline at 8 weeks
Range of motion of upper limb joints
Time frame: Change from Baseline at 8 weeks
Disabilities of The Arm, Shoulder And Hand Questionnaire
Time frame: Change from Baseline at 8 weeks
Side effects record
Time frame: Every training session, total sessions continued to 8 weeks
Satisfaction questionnaire
Time frame: Every training session, total sessions continued to 8 weeks
Wear performance record
Time frame: Every training session, total sessions continued to 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Background: PubMed 33517868Alexander J, Dawson J, Langhorne P. Dynamic hand orthoses for the recovery of hand and arm function in adults after stroke: A systematic review and meta-analysis of randomised controlled trials. Top Stroke Rehabil. 2022 Mar;29(2):114-124. doi: 10.1080/10749357.2021.1878669. Epub 2021 Jan 31.
- BackgroundAtes, S., Haarman, C. J., & Stienen, A. H. J. A. R. (2017). SCRIPT passive orthosis: design of interactive hand and wrist exoskeleton for rehabilitation at home after stroke. 41(3), 711-723.
- BackgroundAzeez, A., Gopichand, A., Shankar, N., Hanumantharao, K. J. I. J. o. E. T., & Technology. (2015). A novel prosthetic hand support for physically disabled. 29(6), 295-298
- Background: PubMed 27594781Baronio G, Harran S, Signoroni A. A Critical Analysis of a Hand Orthosis Reverse Engineering and 3D Printing Process. Appl Bionics Biomech. 2016;2016:8347478. doi: 10.1155/2016/8347478. Epub 2016 Aug 9.
- Background: PubMed 25012864Basteris A, Nijenhuis SM, Stienen AH, Buurke JH, Prange GB, Amirabdollahian F. Training modalities in robot-mediated upper limb rehabilitation in stroke: a framework for classification based on a systematic review. J Neuroeng Rehabil. 2014 Jul 10;11:111. doi: 10.1186/1743-0003-11-111.
- BackgroundCazon, A., Aizpurua, J., Paterson, A., Bibb, R., Campbell, R. I. J. V., & Prototyping, P. (2014). Customised design and manufacture of protective face masks combining a practitioner-friendly modelling approach and low-cost devices for digitising and additive manufacturing: This paper analyses the viability of replacing conventional practice with AM method to make customized protective face masks. 9(4), 251-261.
- BackgroundChang, K., Chang, J.-H., Huang, M.-W., & Lee, L.-Y. (2018). Innovative orthosis for phalanx extension neurofacilitation (iOPEN)-development of a 3D-printed hand orthosis for chronic stroke patient. Paper presented at the 2018 IEEE International Conference on Applied System Invention (ICASI).
- Background: PubMed 25931740Chang WD, Lai PT. New design of home-based dynamic hand splint for hemiplegic hands: a preliminary study. J Phys Ther Sci. 2015 Mar;27(3):829-31. doi: 10.1589/jpts.27.829. Epub 2015 Mar 31.
- Background: PubMed 23867415Copley J, Kuipers K, Fleming J, Rassafiani M. Individualised resting hand splints for adults with acquired brain injury: a randomized, single blinded, single case design. NeuroRehabilitation. 2013;32(4):885-98. doi: 10.3233/NRE-130913.
- Background: PubMed 28649911Diment LE, Thompson MS, Bergmann JH. Three-dimensional printed upper-limb prostheses lack randomised controlled trials: A systematic review. Prosthet Orthot Int. 2018 Feb;42(1):7-13. doi: 10.1177/0309364617704803. Epub 2017 Jun 24.
- Background: PubMed 6622535Duncan PW, Propst M, Nelson SG. Reliability of the Fugl-Meyer assessment of sensorimotor recovery following cerebrovascular accident. Phys Ther. 1983 Oct;63(10):1606-10. doi: 10.1093/ptj/63.10.1606.
- BackgroundEmzain, Z. F., Huang, S.-C., Yang, Y.-S., & Qosim, N. J. R. M. (2020). Design and Analysis of a Dynamic Splint Based on Pulley Rotation for Post-Stroke Finger Extension Rehabilitation Device. 11(3), 477-485.
- Individual participant dataSharing planned: No
Related trials for Stroke
RecruitingPhase 4
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
Cerebrovascular Disorders
Active, not recruiting
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
Stroke, Cognitive Dysfunction
Recruiting
Role of Hypothermia in Endovascular Stroke Thrombectomy
Stroke, Acute Ischemic
RecruitingPhase 3
Treatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease
Cerebral Small Vessel Disease, Ischemic Stroke
Active, not recruiting
Community-Empowerment and Environmental Enrichment-based Co-management (CEEEC) Model and Mechanisms for Improving Health of Older Stroke Patients With Multimorbidity
Hypertension, Type 2 Diabetes Mellitus (T2DM)
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.
Hsinchieh Lee principal investigator
Taipei Medical University, Taiwan, R.O.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D printing splint group and functional splint group in people with Stroke, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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 5 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: withdrawn, as of the sponsor's last update on 20 May 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 Taiwan. 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 was withdrawn before enrolling participants, so there are no results.
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?
Fugl-Meyer Assessment-upper extremity (time frame: Change from Baseline at 8 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 NCT06979934, which also lists 30 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 20 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.