Ultrasonographic Subcutaneous Scar Scoring System for Traumatic Hand Injured Patients

NCT04932109 | Unknown

• 1 other identifier: A-ER-109-425
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand Injuries

Keywords

Traumatic hand injury; Ultrasonography; Subcutaneous scar

Outcome Measures

Primary Outcomes (22)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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.

  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.

  Baseline, within 1 week after baseline

Study Arms (3)

Healthy Group

Other: No intervention

Hand Injuries Group

Other: No intervention

Healthcare professional

Clinical healthcare professionals who specialized in orthopedic, rehabilitation, hand anatomy, musculoskeletal ultrasound and so on

Other: No intervention

Interventions

No intervention OTHER

No intervention in this group

Hand Injuries Group; Healthcare professional; Healthy Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Hand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 18, 2021
• Study Start: January 25, 2021
• Primary Completion: November 26, 2024
• Study Completion: December 31, 2024
• Last Updated: July 18, 2024

Record last verified: 2024-01

Locations

TW (1)