Health AdultsNCT06189235
Ultrasonography-guided Real-time Modular Systems for Hand Therapy
A study testing Biofeedback training in people with Health Adults and Patients With Traumatic Hand Injury, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
This study aimed to develop an ultrasonography-guided real-time modular system and try to apply it to clinical hand therapy using. This study was divided into two parts. The first part is an observational study design. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Adults, Patients With Traumatic Hand Injury
- What is being tested?
- Biofeedback training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Jun 2023to 31 Jul 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Traumatic hand injury (distal from wrist joint above 8 weeks and within one year)
- Able to do active motion and resistive activities
- Understand and cooperate the experiment
- No history of traumatic hand injury and other hand related conditions
- Understand and cooperate the experiment
Who cannot join
- Burn, amputees or has history of arthritis
- Combined with other central or peripheral nerve deficits which cause difficulty in movements
- 【Healthy subjects】
- Burn, amputees or has history of arthritis
- Combined with other central or peripheral nerve deficits which cause difficulty in movements
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University Hospital
Tainan, 704
Li-Chieh Kuo, 886-62353535 ext. 5908, jkkuo@mail.ncku.edu.tw
About this study
Official title: Development of Ultrasonography-guided Real-time Intelligent Monitoring, Evaluation and Biofeedback Training Modular Systems for Hand Therapy
This study aimed to develop an ultrasonography-guided real-time modular system and try to apply it to clinical hand therapy using.
This study was divided into two parts. The first part is an observational study design. The ultrasonography-guided real-time modular system will be developed and integrated, and its overall reliability and validity will be tested in this part. Once the software and hardware of the modular system has been established, numerous hand-related ultrasonography data will be collected for building an artificial intelligence model for detecting the anatomic structures in hand, evaluating the status of the tissues in hand.
The second part is an interventional study design. The clinical application of the modular system on hand injured patients is conducted, and the biofeedback mechanics will also be defined in the second part. The patients will be recruited into the research to receive both traditional rehabilitation and the one which combines with biofeedback training via the modular system. The effect of the traditional and biofeedback-added rehabilitation will be compared.
- Conditions
- Health Adults, Patients With Traumatic Hand Injury
- Being tested
- Biofeedback training
- Keywords
- Ultrasonography-guided, Biofeedback, Hand therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback trainingOther
The target of additional biofeedback training is to provide hints which are related to the essential aspects during hand therapy such as the stress on the tissue and the distance of tendon gliding.
| Study group | Role | What they receive |
|---|---|---|
| System development: Validation for patients | No intervention | No intervention. The patients will receive one time of MRI and three times of ultrasound evaluation on the injured area, each evaluaitons will be done by two to three days interval. |
| System development: Building dataset from healthy subjects | No intervention | No intervention. The healthy subjects will receive one time of ultrasound evaluation on the dominant hand, the different part and different axis in dominant hand will be assessed in types of images or films for building the dataset. |
| System application: Understanding the recovery patterns in patients | No intervention | No intervention. The patients will receive three times of ultrasound evaluation on the injured area and hand function assessments, each evaluaitons will be done by two weeks interval. |
| System application: Biofeedback training | Experimental | The program last for one month. In this program, the patients receive traditional rehabilitation protocol assigned from original hospital or therapist. Also, ultrasound evaluation and hand function assessment will be performed at pre-test, one follow-up test and post-test, which will be done with two weeks interval.
For this biofeedback training group, the therapist and patients will be asked to use the hint recommanded by modular system to assist the rehabilitation excepting the traditional routine at least two times a week. Receives: Other: Biofeedback training |
| System application: Traditional training | No intervention | The program last for one month. In this program, the patients receive traditional rehabilitation protocol assigned from original hospital or therapist. Also, ultrasound evaluation and hand function assessment will be performed at pre-test, one follow-up test and post-test, which will be done with two weeks interval. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tissue characteristics - Ultrasonography platform - Hand Injuries Group (System development) - Baseline
An ultrasonography platform and different installed modes will be used to gather the images from affected and unaffected hand of patients with hand injuries. These data will be collected three times in hand injuries group to know how will the tissue change between different time points.
Measured: Baseline, 2-3 days after baseline, 4-5 days after baseline
Change from Baseline tissue characteristics at 2-3 days - Ultrasonography platform - Hand Injuries Group (System development) - 2-3 days after baseline
An ultrasonography platform and different installed modes will be used to gather the images from affected and unaffected hand of patients with hand injuries. These data will be collected three times in hand injuries group to know how will the tissue change between different time points.
Measured: Baseline, 2-3 days after baseline, 4-5 days after baseline
Change from Baseline tissue characteristics at 4-5 days - Ultrasonography platform - Hand Injuries Group (System development) - 4-5 days after baseline
An ultrasonography platform and different installed modes will be used to gather the images from affected and unaffected hand of patients with hand injuries. These data will be collected three times in hand injuries group to know how will the tissue change between different time points.
Measured: Baseline, 2-3 days after baseline, 4-5 days after baseline
Ultrasonography platform - Healthy Group - Baseline
An ultrasonography platform and different installed modes will be used to gather the images and films from dominant hand of healthy adults for building the dataset.
Measured: Baseline
Change in tissue characteristics - Ultrasonography platform - Hand Injuries Group (System application) - Baseline
An ultrasonography platform and different installed modes will be used to gather the images from affected and unaffected hand of patients with hand injuries. These data will be collected three times in hand injuries group to know how will the tissue change between different time points.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline tissue characteristics at 2 weeks - Ultrasonography platform - Hand Injuries Group (System application) - 2 weeks after baseline
An ultrasonography platform and different installed modes will be used to gather the images from affected and unaffected hand of patients with hand injuries. These data will be collected three times in hand injuries group to know how will the tissue change between different time points.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline tissue characteristics at 4 weeks - Ultrasonography platform - Hand Injuries Group (System application) - 4 weeks after baseline
An ultrasonography platform and different installed modes will be used to gather the images from affected and unaffected hand of patients with hand injuries. These data will be collected three times in hand injuries group to know how will the tissue change between different time points.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Change in joint ROM - Goniometer - Hand Injuries Group (System application) - Baseline
The goniometer will be used to measure the range of motion (ROM) in the affected and affected finger.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline joint ROM at 2 weeks - Goniometer - Hand Injuries Group (System application) - 2 weeks after baseline
The goniometer will be used to measure the range of motion (ROM) in the affected and affected finger.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline joint ROM at 4 weeks - Goniometer - Hand Injuries Group (System application) - 4 weeks after baseline
The goniometer will be used to measure the range of motion (ROM) in the affected and affected finger.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Change in single digit force - Force sensors - Hand Injuries Group (System application) - Baseline
A force sensor will be used to collect the single digit force data in affected and unaffected finger.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline single digit force at 2 weeks - Force sensors - Hand Injuries Group (System application) - 2 weeks after baseline
A force sensor will be used to collect the single digit force data in affected and unaffected finger.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline single digit force at 4 weeks - Force sensors - Hand Injuries Group (System application) - 4 weeks after baseline
A force sensor will be used to collect the single digit force data in affected and unaffected finger.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Change in grip and pinch force - Hand dynamometer - Hand Injuries Group (System application) - Baseline
Hand dynamometer will be used to measure the grip strength and pinch strength.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline grip and pinch force at 2 weeks - Hand dynamometer - Hand Injuries Group (System application) - 2 weeks after baseline
Hand dynamometer will be used to measure the grip strength and pinch strength.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline grip and pinch force at 4 weeks - Hand dynamometer - Hand Injuries Group (System application) - 4 weeks after baseline
Hand dynamometer will be used to measure the grip strength and pinch strength.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Change in hand dexterity - Purdue pegboard test - Hand Injuries Group (System application) - Baseline
The Purdue pegboard test will be used to test the unimanual and bimanual manipulation versus hand dexterity.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline hand dexterity at 2 weeks - Purdue pegboard test - Hand Injuries Group (System application) - 2 weeks after baseline
The Purdue pegboard test will be used to test the unimanual and bimanual manipulation versus hand dexterity.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline hand dexterity at 4 weeks - Purdue pegboard test - Hand Injuries Group (System application) - 4 weeks after baseline
The Purdue pegboard test will be used to test the unimanual and bimanual manipulation versus hand dexterity.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Change in perspective hand function - Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group (System application) - Baseline
The Disabilities of the Arm, Shoulder and Hand (DASH) is a questionnaire, which will be used to evaluate disorders and measure disability of the upper extremities and monitor change or function over time.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline perspective hand function at 2 weeks - Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group (System application) - 2 weeks after baseline
The Disabilities of the Arm, Shoulder and Hand (DASH) is a questionnaire, which will be used to evaluate disorders and measure disability of the upper extremities and monitor change or function over time.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline perspective hand function at 4 weeks - Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group (System application) - 4 weeks after baseline
The Disabilities of the Arm, Shoulder and Hand (DASH) is a questionnaire, which will be used to evaluate disorders and measure disability of the upper extremities and monitor change or function over time.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start28 Jun 2023
- Primary completion26 Apr 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health AdultsStudies 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
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189235
- Sponsor's protocol ID
- B-ER-111-012
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Ultrasonography-guided Real-time Intelligent Monitoring, Evaluation and Biofeedback Training Modular Systems for Hand Therapy
- ClinicalTrials.gov ID
- NCT06189235
- Acronym / sponsor ID
- B-ER-111-012
- Conditions
- Health Adults, Patients With Traumatic Hand Injury
- Keywords
- Ultrasonography-guided, Biofeedback, Hand therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 26 Apr 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 3 Jan 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.
This study aimed to develop an ultrasonography-guided real-time modular system and try to apply it to clinical hand therapy using.
This study was divided into two parts. The first part is an observational study design. The ultrasonography-guided real-time modular system will be developed and integrated, and its overall reliability and validity will be tested in this part. Once the software and hardware of the modular system has been established, numerous hand-related ultrasonography data will be collected for building an artificial intelligence model for detecting the anatomic structures in hand, evaluating the status of the tissues in hand.
The second part is an interventional study design. The clinical application of the modular system on hand injured patients is conducted, and the biofeedback mechanics will also be defined in the second part. The patients will be recruited into the research to receive both traditional rehabilitation and the one which combines with biofeedback training via the modular system. The effect of the traditional and biofeedback-added rehabilitation will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| System development: Validation for patients | No intervention | –No intervention. The patients will receive one time of MRI and three times of ultrasound evaluation on the injured area, each evaluaitons will be done by two to three days interval. |
| System development: Building dataset from healthy subjects | No intervention | –No intervention. The healthy subjects will receive one time of ultrasound evaluation on the dominant hand, the different part and different axis in dominant hand will be assessed in types of images or films for building the dataset. |
| System application: Understanding the recovery patterns in patients | No intervention | –No intervention. The patients will receive three times of ultrasound evaluation on the injured area and hand function assessments, each evaluaitons will be done by two weeks interval. |
| System application: Biofeedback training | Experimental | Other: Biofeedback trainingThe program last for one month. In this program, the patients receive traditional rehabilitation protocol assigned from original hospital or therapist. Also, ultrasound evaluation and hand function assessment will be performed at pre-test, one follow-up test and post-test, which will be done with two weeks interval. For this biofeedback training group, the therapist and patients will be asked to use the hint recommanded by modular system to assist the rehabilitation excepting the traditional routine at least two times a week. |
| System application: Traditional training | No intervention | –The program last for one month. In this program, the patients receive traditional rehabilitation protocol assigned from original hospital or therapist. Also, ultrasound evaluation and hand function assessment will be performed at pre-test, one follow-up test and post-test, which will be done with two weeks interval. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Traumatic hand injury (distal from wrist joint above 8 weeks and within one year)
- Able to do active motion and resistive activities
- Understand and cooperate the experiment
- No history of traumatic hand injury and other hand related conditions
- Understand and cooperate the experiment
Key exclusion criteria (5 listed)
- Burn, amputees or has history of arthritis
- Combined with other central or peripheral nerve deficits which cause difficulty in movements
- 【Healthy subjects】
- Burn, amputees or has history of arthritis
- Combined with other central or peripheral nerve deficits which cause difficulty in movements
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 |
|---|---|---|
| Biofeedback trainingThe target of additional biofeedback training is to provide hints which are related to the essential aspects during hand therapy such as the stress on the tissue and the distance of tendon gliding. | Other | System application: Biofeedback training |
Primary outcome
Change in tissue characteristics - Ultrasonography platform - Hand Injuries Group (System development) - Baseline
Time frame: Baseline, 2-3 days after baseline, 4-5 days after baseline
An ultrasonography platform and different installed modes will be used to gather the images from affected and unaffected hand of patients with hand injuries. These data will be collected three times in hand injuries group to know how will the tissue change between different time points.
Change from Baseline tissue characteristics at 2-3 days - Ultrasonography platform - Hand Injuries Group (System development) - 2-3 days after baseline
Time frame: Baseline, 2-3 days after baseline, 4-5 days after baseline
An ultrasonography platform and different installed modes will be used to gather the images from affected and unaffected hand of patients with hand injuries. These data will be collected three times in hand injuries group to know how will the tissue change between different time points.
Change from Baseline tissue characteristics at 4-5 days - Ultrasonography platform - Hand Injuries Group (System development) - 4-5 days after baseline
Time frame: Baseline, 2-3 days after baseline, 4-5 days after baseline
An ultrasonography platform and different installed modes will be used to gather the images from affected and unaffected hand of patients with hand injuries. These data will be collected three times in hand injuries group to know how will the tissue change between different time points.
Ultrasonography platform - Healthy Group - Baseline
Time frame: Baseline
An ultrasonography platform and different installed modes will be used to gather the images and films from dominant hand of healthy adults for building the dataset.
Change in tissue characteristics - Ultrasonography platform - Hand Injuries Group (System application) - Baseline
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline
An ultrasonography platform and different installed modes will be used to gather the images from affected and unaffected hand of patients with hand injuries. These data will be collected three times in hand injuries group to know how will the tissue change between different time points.
Change from Baseline tissue characteristics at 2 weeks - Ultrasonography platform - Hand Injuries Group (System application) - 2 weeks after baseline
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline
An ultrasonography platform and different installed modes will be used to gather the images from affected and unaffected hand of patients with hand injuries. These data will be collected three times in hand injuries group to know how will the tissue change between different time points.
Change from Baseline tissue characteristics at 4 weeks - Ultrasonography platform - Hand Injuries Group (System application) - 4 weeks after baseline
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline
An ultrasonography platform and different installed modes will be used to gather the images from affected and unaffected hand of patients with hand injuries. These data will be collected three times in hand injuries group to know how will the tissue change between different time points.
Change in joint ROM - Goniometer - Hand Injuries Group (System application) - Baseline
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline
The goniometer will be used to measure the range of motion (ROM) in the affected and affected finger.
Change from Baseline joint ROM at 2 weeks - Goniometer - Hand Injuries Group (System application) - 2 weeks after baseline
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline
The goniometer will be used to measure the range of motion (ROM) in the affected and affected finger.
Change from Baseline joint ROM at 4 weeks - Goniometer - Hand Injuries Group (System application) - 4 weeks after baseline
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline
The goniometer will be used to measure the range of motion (ROM) in the affected and affected finger.
Change in single digit force - Force sensors - Hand Injuries Group (System application) - Baseline
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline
A force sensor will be used to collect the single digit force data in affected and unaffected finger.
Change from Baseline single digit force at 2 weeks - Force sensors - Hand Injuries Group (System application) - 2 weeks after baseline
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline
A force sensor will be used to collect the single digit force data in affected and unaffected finger.
Change from Baseline single digit force at 4 weeks - Force sensors - Hand Injuries Group (System application) - 4 weeks after baseline
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline
A force sensor will be used to collect the single digit force data in affected and unaffected finger.
Change in grip and pinch force - Hand dynamometer - Hand Injuries Group (System application) - Baseline
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline
Hand dynamometer will be used to measure the grip strength and pinch strength.
Change from Baseline grip and pinch force at 2 weeks - Hand dynamometer - Hand Injuries Group (System application) - 2 weeks after baseline
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline
Hand dynamometer will be used to measure the grip strength and pinch strength.
Change from Baseline grip and pinch force at 4 weeks - Hand dynamometer - Hand Injuries Group (System application) - 4 weeks after baseline
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline
Hand dynamometer will be used to measure the grip strength and pinch strength.
Change in hand dexterity - Purdue pegboard test - Hand Injuries Group (System application) - Baseline
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline
The Purdue pegboard test will be used to test the unimanual and bimanual manipulation versus hand dexterity.
Change from Baseline hand dexterity at 2 weeks - Purdue pegboard test - Hand Injuries Group (System application) - 2 weeks after baseline
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline
The Purdue pegboard test will be used to test the unimanual and bimanual manipulation versus hand dexterity.
Change from Baseline hand dexterity at 4 weeks - Purdue pegboard test - Hand Injuries Group (System application) - 4 weeks after baseline
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline
The Purdue pegboard test will be used to test the unimanual and bimanual manipulation versus hand dexterity.
Change in perspective hand function - Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group (System application) - Baseline
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline
The Disabilities of the Arm, Shoulder and Hand (DASH) is a questionnaire, which will be used to evaluate disorders and measure disability of the upper extremities and monitor change or function over time.
Change from Baseline perspective hand function at 2 weeks - Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group (System application) - 2 weeks after baseline
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline
The Disabilities of the Arm, Shoulder and Hand (DASH) is a questionnaire, which will be used to evaluate disorders and measure disability of the upper extremities and monitor change or function over time.
Change from Baseline perspective hand function at 4 weeks - Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group (System application) - 4 weeks after baseline
Time frame: Baseline, 2 weeks after baseline, 4 weeks after baseline
The Disabilities of the Arm, Shoulder and Hand (DASH) is a questionnaire, which will be used to evaluate disorders and measure disability of the upper extremities and monitor change or function over time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback training in people with Health Adults and Patients With Traumatic Hand Injury, run by National Cheng-Kung University 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 5 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: status not confirmed, as of the sponsor's last update on 3 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li-Chieh Kuo, Ph. D. (886-62353535 ext. 5908, jkkuo@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tissue characteristics - Ultrasonography platform - Hand Injuries Group (System development) - Baseline (time frame: Baseline, 2-3 days after baseline, 4-5 days after baseline). The study lists 22 primary outcomes in all. 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 3 Jan 2024.