Hand InjuriesNCT04932109
Ultrasonographic Subcutaneous Scar Scoring System for Traumatic Hand Injured Patients
An observational study of Hand Injuries, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
This study aims to develop an objective scar scoring system via ultrasonography and try to apply it to clinical using. This study was divided into two parts. The first part of the study 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
- Hand Injuries
- How many people
- 83 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Jan 2021to 31 Dec 2024
- Phase
- Observational
- 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
Study population: Patients with traumatic hand injuries will be recruited from the Department of Rehabilitation in National Cheng Kung University Hospital
Who may be able to join
- Above 20 years old
- 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
Who cannot join
- Injured by burn
- Have impairment in peripheral nerve and affect the movement
- Combined with other central nerve deficits
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng-Kung University Hospital
Tainan, 704
Li-Chieh Kuo, Ph. D., 886-62353535 ext. 5908, jkkuo@mail.ncku.edu.tw
About this study
Official title: Development of a Subcutaneous Scar Scoring System Via Ultrasonography and Its Association With Hand Function in Traumatic Hand Injured Patients
This study aims to develop an objective scar scoring system via ultrasonography and try to apply it to clinical using.
This study was divided into two parts. The first part of the study is an observational study design. The scar scoring system will be developed, and its test-retest reliability and criterion-related validity will be tested in this part.
The second part is also an observational study design. The clinical application of the system on traumatic injured patients is conducted in the second part. The results from this scar scoring system are correlated with hand function measurements. Moreover, every scar will be recorded three times within one month during routine rehabilitation to investigate the change.
- Conditions
- Hand Injuries
- Being tested
- No intervention
- Keywords
- Traumatic hand injury, Ultrasonography, Subcutaneous scar
- Medical subject headings
- Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention in this group
| Study group | Role | What they receive |
|---|---|---|
| Healthy Group | Not described Receives: Other: No intervention | |
| Hand Injuries Group | Not described Receives: Other: No intervention | |
| Healthcare professional | Clinical healthcare professionals who specialized in orthopedic, rehabilitation, hand anatomy, musculoskeletal ultrasound and so on Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography platform - Healthy Group - Baseline
An ultrasonography platform and different installed modes will be used to gather the images from dominant hand of healthy adults. These data will be collected two times in healthy group to test the test-retest reliability of the system.
Measured: Baseline, 2 days after baseline
Ultrasonography platform - Healthy Group - 2 days after baseline
An ultrasonography platform and different installed modes will be used to gather the images from dominant hand of healthy adults. These data will be collected two times in healthy group to test the test-retest reliability of the system.
Measured: Baseline, 2 days after baseline
Ultrasonography platform - Hand Injuries Group - 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
Ultrasonography platform - Hand Injuries Group - 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
Ultrasonography platform - Hand Injuries Group - 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
Goniometer - Hand Injuries Group - 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
Goniometer - Hand Injuries Group - 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
Goniometer - Hand Injuries Group - 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
Force sensors - Hand Injuries Group - 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
Force sensors - Hand Injuries Group - 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
Force sensors - Hand Injuries Group - 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
Hand dynamometer - Hand Injuries Group - Baseline
Hand dynamometer will be used to measure the grip strength and pinch strength.
Measured: Baseline, 2 weeks after baseline, 4 weeks after baseline
Hand dynamometer - Hand Injuries Group - 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
Hand dynamometer - Hand Injuries Group - 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
Purdue pegboard test - Hand Injuries Group - 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
Purdue pegboard test - Hand Injuries Group - 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
Purdue pegboard test - Hand Injuries Group - 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
Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group - 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
Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group - 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
Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group - 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
Ultrasonography platform - Healthcare professional - Baseline
An ultrasonography platform and different installed modes will be used to gather the images. The healthcare professionals will as the users to collect images from phantom or hand tissues. These data will be collected up to two times in healthcare professional group to test the test-retest reliability of the system and the effect of different experience levels.
Measured: Baseline, within 1 week after baseline
Ultrasonography platform - Healthcare professional - within 1 week after baseline
An ultrasonography platform and different installed modes will be used to gather the images. The healthcare professionals will as the users to collect images from phantom or hand tissues. These data will be collected up to two times in healthcare professional group to test the test-retest reliability of the system and the effect of different experience levels.
Measured: Baseline, within 1 week after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start25 Jan 2021
- Primary completion26 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 83 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
- NCT04932109
- Sponsor's protocol ID
- A-ER-109-425
- Status last verified
- Jan 2024
- First submitted
- 14 Jun 2021
- Last updated
- 18 Jul 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 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Subcutaneous Scar Scoring System Via Ultrasonography and Its Association With Hand Function in Traumatic Hand Injured Patients
- ClinicalTrials.gov ID
- NCT04932109
- Acronym / sponsor ID
- A-ER-109-425
- Conditions
- Hand Injuries
- Keywords
- Traumatic hand injury, Ultrasonography, Subcutaneous scar
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 26 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Jun 2021 (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 aims to develop an objective scar scoring system via ultrasonography and try to apply it to clinical using.
This study was divided into two parts. The first part of the study is an observational study design. The scar scoring system will be developed, and its test-retest reliability and criterion-related validity will be tested in this part.
The second part is also an observational study design. The clinical application of the system on traumatic injured patients is conducted in the second part. The results from this scar scoring system are correlated with hand function measurements. Moreover, every scar will be recorded three times within one month during routine rehabilitation to investigate the change.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Group | – | Other: No intervention |
| Hand Injuries Group | – | Other: No intervention |
| Healthcare professional | – | Other: No interventionClinical healthcare professionals who specialized in orthopedic, rehabilitation, hand anatomy, musculoskeletal ultrasound and so on |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with traumatic hand injuries will be recruited from the Department of Rehabilitation in National Cheng Kung University Hospital
Key inclusion criteria (4 listed)
- Above 20 years old
- 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
Key exclusion criteria (3 listed)
- Injured by burn
- Have impairment in peripheral nerve and affect the movement
- Combined with other central nerve deficits
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 |
|---|---|---|
| No interventionNo intervention in this group | Other | Hand Injuries Group, Healthcare professional, Healthy Group |
Primary outcome
Ultrasonography platform - Healthy Group - Baseline
Time frame: Baseline, 2 days after baseline
An ultrasonography platform and different installed modes will be used to gather the images from dominant hand of healthy adults. These data will be collected two times in healthy group to test the test-retest reliability of the system.
Ultrasonography platform - Healthy Group - 2 days after baseline
Time frame: Baseline, 2 days after baseline
An ultrasonography platform and different installed modes will be used to gather the images from dominant hand of healthy adults. These data will be collected two times in healthy group to test the test-retest reliability of the system.
Ultrasonography platform - Hand Injuries Group - 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.
Ultrasonography platform - Hand Injuries Group - 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.
Ultrasonography platform - Hand Injuries Group - 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.
Goniometer - Hand Injuries Group - 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.
Goniometer - Hand Injuries Group - 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.
Goniometer - Hand Injuries Group - 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.
Force sensors - Hand Injuries Group - 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.
Force sensors - Hand Injuries Group - 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.
Force sensors - Hand Injuries Group - 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.
Hand dynamometer - Hand Injuries Group - 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.
Hand dynamometer - Hand Injuries Group - 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.
Hand dynamometer - Hand Injuries Group - 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.
Purdue pegboard test - Hand Injuries Group - 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.
Purdue pegboard test - Hand Injuries Group - 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.
Purdue pegboard test - Hand Injuries Group - 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.
Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group - 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.
Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group - 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.
Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group - 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.
Ultrasonography platform - Healthcare professional - Baseline
Time frame: Baseline, within 1 week after baseline
An ultrasonography platform and different installed modes will be used to gather the images. The healthcare professionals will as the users to collect images from phantom or hand tissues. These data will be collected up to two times in healthcare professional group to test the test-retest reliability of the system and the effect of different experience levels.
Ultrasonography platform - Healthcare professional - within 1 week after baseline
Time frame: Baseline, within 1 week after baseline
An ultrasonography platform and different installed modes will be used to gather the images. The healthcare professionals will as the users to collect images from phantom or hand tissues. These data will be collected up to two times in healthcare professional group to test the test-retest reliability of the system and the effect of different experience levels.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 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?
An observational study of Hand Injuries, 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 4 inclusion and 3 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 18 Jul 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonography platform - Healthy Group - Baseline (time frame: Baseline, 2 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 18 Jul 2024.