Clinical trial NCT04932109: Ultrasonographic Subcutaneous Scar Scoring System for Traumatic Hand Injured Patients
Official title: Development of a Subcutaneous Scar Scoring System Via Ultrasonography and Its Association With Hand Function in Traumatic Hand Injured Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hand Injuries
Keywords: Traumatic hand injury
Ultrasonography
Subcutaneous scar
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 83
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Ultrasonography platform - Healthy Group - Baseline
timeFrame: Baseline, 2 days after baseline
measure: Ultrasonography platform - Healthy Group - 2 days after baseline
timeFrame: Baseline, 2 days after baseline
measure: Ultrasonography platform - Hand Injuries Group - Baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Ultrasonography platform - Hand Injuries Group - 2 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Ultrasonography platform - Hand Injuries Group - 4 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Goniometer - Hand Injuries Group - Baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Goniometer - Hand Injuries Group - 2 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Goniometer - Hand Injuries Group - 4 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Force sensors - Hand Injuries Group - Baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Force sensors - Hand Injuries Group - 2 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Force sensors - Hand Injuries Group - 4 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Hand dynamometer - Hand Injuries Group - Baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Hand dynamometer - Hand Injuries Group - 2 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Hand dynamometer - Hand Injuries Group - 4 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Purdue pegboard test - Hand Injuries Group - Baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Purdue pegboard test - Hand Injuries Group - 2 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Purdue pegboard test - Hand Injuries Group - 4 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group - Baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group - 2 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group - 4 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Ultrasonography platform - Healthcare professional - Baseline
timeFrame: Baseline, within 1 week after baseline
measure: Ultrasonography platform - Healthcare professional - within 1 week after baseline
timeFrame: Baseline, within 1 week after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
References: