Ultrasonographic Subcutaneous Scar Scoring System for Traumatic Hand Injured Patients

July 16, 2024 updated by: National Cheng-Kung University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng-Kung University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with traumatic hand injuries will be recruited from the Department of Rehabilitation in National Cheng Kung University Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Group
Other: No intervention
No intervention in this group
Hand Injuries Group
Other: No intervention
No intervention in this group
Healthcare professional
Clinical healthcare professionals who specialized in orthopedic, rehabilitation, hand anatomy, musculoskeletal ultrasound and so on
Other: No intervention
No intervention in this group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 2 days after baseline
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.
Baseline, 2 days after baseline
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.
Baseline, 2 weeks after baseline, 4 weeks after baseline
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.
Baseline, 2 weeks after baseline, 4 weeks after baseline
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.
Baseline, 2 weeks after baseline, 4 weeks after baseline
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.
Baseline, 2 weeks after baseline, 4 weeks after baseline
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.
Baseline, 2 weeks after baseline, 4 weeks after baseline
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.
Baseline, 2 weeks after baseline, 4 weeks after baseline
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.
Baseline, 2 weeks after baseline, 4 weeks after baseline
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.
Baseline, 2 weeks after baseline, 4 weeks after baseline
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.
Baseline, 2 weeks after baseline, 4 weeks after baseline
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.
Baseline, 2 weeks after baseline, 4 weeks after baseline
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.
Baseline, 2 weeks after baseline, 4 weeks after baseline
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.
Baseline, 2 weeks after baseline, 4 weeks after baseline
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.
Baseline, 2 weeks after baseline, 4 weeks after baseline
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.
Baseline, 2 weeks after baseline, 4 weeks after baseline
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.
Baseline, 2 weeks after baseline, 4 weeks after baseline
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.
Baseline, 2 weeks after baseline, 4 weeks after baseline
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.
Baseline, 2 weeks after baseline, 4 weeks after baseline
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.
Baseline, 2 weeks after baseline, 4 weeks after baseline
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.
Baseline, within 1 week after baseline
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.
Baseline, within 1 week after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cheng-Kung University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2021

Primary Completion (Estimated)

November 26, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

June 17, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-ER-109-425

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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