Ultrasonographic Subcutaneous Scar Scoring System for Traumatic Hand Injured Patients

Hand Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04932109
• Other study ID #: A-ER-109-425
• Status: Recruiting
• Start date: January 25, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 31, 2024
• Est. primary completion date: November 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hand Injuries

Intervention

Other:
• No intervention
No intervention in this group

Locations

Country	Name	City	State
Taiwan	National Cheng-Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 2 days after baseline
Primary	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.	Baseline, 2 days after baseline
Primary	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.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Primary	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.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Primary	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.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Primary	Goniometer - Hand Injuries Group - 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
Primary	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.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Primary	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.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Primary	Force sensors - Hand Injuries Group - 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
Primary	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.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Primary	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.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Primary	Hand dynamometer - Hand Injuries Group - Baseline	Hand dynamometer will be used to measure the grip strength and pinch strength.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Primary	Hand dynamometer - Hand Injuries Group - 2 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
Primary	Hand dynamometer - Hand Injuries Group - 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
Primary	Purdue pegboard test - Hand Injuries Group - 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
Primary	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.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Primary	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.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Primary	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.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Primary	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.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Primary	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.	Baseline, 2 weeks after baseline, 4 weeks after baseline