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Ultrasonographic Subcutaneous Scar Scoring System for Traumatic Hand Injured Patients

Development of a Subcutaneous Scar Scoring System Via Ultrasonography and Its Association With Hand Function in Traumatic Hand Injured Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04932109
Enrollment
83
Registered
2021-06-18
Start date
2021-01-25
Completion date
2024-12-31
Last updated
2024-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Injuries

Keywords

Traumatic hand injury, Ultrasonography, Subcutaneous scar

Brief 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. 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.

Interventions

OTHERNo intervention

No intervention in this group

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* Injured by burn * Have impairment in peripheral nerve and affect the movement * Combined with other central nerve deficits

Design outcomes

Primary

MeasureTime frameDescription
Ultrasonography platform - Healthy Group - BaselineBaseline, 2 days after baselineAn 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 baselineBaseline, 2 days after baselineAn 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 - BaselineBaseline, 2 weeks after baseline, 4 weeks after baselineAn 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 baselineBaseline, 2 weeks after baseline, 4 weeks after baselineAn 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 baselineBaseline, 2 weeks after baseline, 4 weeks after baselineAn 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 - BaselineBaseline, 2 weeks after baseline, 4 weeks after baselineThe goniometer will be used to measure the range of motion (ROM) in the affected and affected finger.
Goniometer - Hand Injuries Group - 2 weeks after baselineBaseline, 2 weeks after baseline, 4 weeks after baselineThe goniometer will be used to measure the range of motion (ROM) in the affected and affected finger.
Goniometer - Hand Injuries Group - 4 weeks after baselineBaseline, 2 weeks after baseline, 4 weeks after baselineThe goniometer will be used to measure the range of motion (ROM) in the affected and affected finger.
Force sensors - Hand Injuries Group - BaselineBaseline, 2 weeks after baseline, 4 weeks after baselineA 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 baselineBaseline, 2 weeks after baseline, 4 weeks after baselineA 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 baselineBaseline, 2 weeks after baseline, 4 weeks after baselineA force sensor will be used to collect the single digit force data in affected and unaffected finger.
Hand dynamometer - Hand Injuries Group - BaselineBaseline, 2 weeks after baseline, 4 weeks after baselineHand dynamometer will be used to measure the grip strength and pinch strength.
Hand dynamometer - Hand Injuries Group - 2 weeks after baselineBaseline, 2 weeks after baseline, 4 weeks after baselineHand dynamometer will be used to measure the grip strength and pinch strength.
Hand dynamometer - Hand Injuries Group - 4 weeks after baselineBaseline, 2 weeks after baseline, 4 weeks after baselineHand dynamometer will be used to measure the grip strength and pinch strength.
Purdue pegboard test - Hand Injuries Group - BaselineBaseline, 2 weeks after baseline, 4 weeks after baselineThe 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 baselineBaseline, 2 weeks after baseline, 4 weeks after baselineThe 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 baselineBaseline, 2 weeks after baseline, 4 weeks after baselineThe 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 - BaselineBaseline, 2 weeks after baseline, 4 weeks after baselineThe 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 baselineBaseline, 2 weeks after baseline, 4 weeks after baselineThe 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 baselineBaseline, 2 weeks after baseline, 4 weeks after baselineThe 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 - BaselineBaseline, within 1 week after baselineAn 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 baselineBaseline, within 1 week after baselineAn 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026