Development of a Subcutaneous Scar Scoring System Via Ultrasonography and Its Association With Hand Function in Traumatic Hand Injured Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Ultrasonography platform - Hand Injuries Group - 4 weeks after baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Injured by burn
- •Have impairment in peripheral nerve and affect the movement
- •Combined with other central nerve deficits
结局指标
主要结局
Ultrasonography platform - Hand Injuries Group - 4 weeks after baseline
时间窗: 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.
Goniometer - Hand Injuries Group - 4 weeks after baseline
时间窗: 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.
Hand dynamometer - Hand Injuries Group - 4 weeks after baseline
时间窗: Baseline, 2 weeks after baseline, 4 weeks after baseline
Hand dynamometer will be used to measure the grip strength and pinch strength.
Ultrasonography platform - Healthy Group - Baseline
时间窗: 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.
Goniometer - Hand Injuries Group - Baseline
时间窗: 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.
Force sensors - Hand Injuries Group - Baseline
时间窗: 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.
Force sensors - Hand Injuries Group - 2 weeks after baseline
时间窗: 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.
Ultrasonography platform - Healthy Group - 2 days after baseline
时间窗: 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.
Ultrasonography platform - Hand Injuries Group - Baseline
时间窗: 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.
Ultrasonography platform - Hand Injuries Group - 2 weeks after baseline
时间窗: 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.
Goniometer - Hand Injuries Group - 2 weeks after baseline
时间窗: 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.
Purdue pegboard test - Hand Injuries Group - Baseline
时间窗: 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.
Purdue pegboard test - Hand Injuries Group - 2 weeks after baseline
时间窗: 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.
Purdue pegboard test - Hand Injuries Group - 4 weeks after baseline
时间窗: 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.
Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group - 2 weeks after baseline
时间窗: 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.
Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group - 4 weeks after baseline
时间窗: 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.
Force sensors - Hand Injuries Group - 4 weeks after baseline
时间窗: 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.
Hand dynamometer - Hand Injuries Group - Baseline
时间窗: Baseline, 2 weeks after baseline, 4 weeks after baseline
Hand dynamometer will be used to measure the grip strength and pinch strength.
Hand dynamometer - Hand Injuries Group - 2 weeks after baseline
时间窗: Baseline, 2 weeks after baseline, 4 weeks after baseline
Hand dynamometer will be used to measure the grip strength and pinch strength.
Ultrasonography platform - Healthcare professional - within 1 week after baseline
时间窗: 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.
Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group - Baseline
时间窗: 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.
Ultrasonography platform - Healthcare professional - Baseline
时间窗: 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.
次要结局
未报告次要终点