Development of Ultrasonography-guided Real-time Intelligent Monitoring, Evaluation and Biofeedback Training Modular Systems for Hand Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 149
- 试验地点
- 2
- 主要终点
- Change in tissue characteristics - Ultrasonography platform - Hand Injuries Group (System development) - Baseline
研究概览
简要总结
This study aimed to develop an ultrasonography-guided real-time modular system and try to apply it to clinical hand therapy using.
This study was divided into two parts. The first part is an observational study design. The ultrasonography-guided real-time modular system will be developed and integrated, and its overall reliability and validity will be tested in this part. Once the software and hardware of the modular system has been established, numerous hand-related ultrasonography data will be collected for building an artificial intelligence model for detecting the anatomic structures in hand, evaluating the status of the tissues in hand.
The second part is an interventional study design. The clinical application of the modular system on hand injured patients is conducted, and the biofeedback mechanics will also be defined in the second part. The patients will be recruited into the research to receive both traditional rehabilitation and the one which combines with biofeedback training via the modular system. The effect of the traditional and biofeedback-added rehabilitation will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •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
- •Burn, amputees or has history of arthritis
- •Combined with other central or peripheral nerve deficits which cause difficulty in movements
- •【Healthy subjects】
- •Inclusion Criteria:
- •No history of traumatic hand injury and other hand related conditions
- •Understand and cooperate the experiment
- •Exclusion Criteria:
- •Burn, amputees or has history of arthritis
- •Combined with other central or peripheral nerve deficits which cause difficulty in movements
结局指标
主要结局
Change in tissue characteristics - Ultrasonography platform - Hand Injuries Group (System development) - Baseline
时间窗: Baseline, 2-3 days after baseline, 4-5 days 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.
Change in joint ROM - Goniometer - Hand Injuries Group (System application) - 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.
Change from Baseline tissue characteristics at 2-3 days - Ultrasonography platform - Hand Injuries Group (System development) - 2-3 days after baseline
时间窗: Baseline, 2-3 days after baseline, 4-5 days 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.
Change from Baseline tissue characteristics at 4-5 days - Ultrasonography platform - Hand Injuries Group (System development) - 4-5 days after baseline
时间窗: Baseline, 2-3 days after baseline, 4-5 days 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.
Change in tissue characteristics - Ultrasonography platform - Hand Injuries Group (System application) - 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.
Change from Baseline joint ROM at 4 weeks - Goniometer - Hand Injuries Group (System application) - 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.
Change from Baseline single digit force at 2 weeks - Force sensors - Hand Injuries Group (System application) - 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.
Change in grip and pinch force - Hand dynamometer - Hand Injuries Group (System application) - 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.
Change from Baseline grip and pinch force at 2 weeks - Hand dynamometer - Hand Injuries Group (System application) - 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.
Change from Baseline hand dexterity at 4 weeks - Purdue pegboard test - Hand Injuries Group (System application) - 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.
Change in perspective hand function - Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group (System application) - 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.
Change from Baseline joint ROM at 2 weeks - Goniometer - Hand Injuries Group (System application) - 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.
Change from Baseline single digit force at 4 weeks - Force sensors - Hand Injuries Group (System application) - 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.
Ultrasonography platform - Healthy Group - Baseline
时间窗: Baseline
An ultrasonography platform and different installed modes will be used to gather the images and films from dominant hand of healthy adults for building the dataset.
Change from Baseline tissue characteristics at 2 weeks - Ultrasonography platform - Hand Injuries Group (System application) - 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.
Change from Baseline tissue characteristics at 4 weeks - Ultrasonography platform - Hand Injuries Group (System application) - 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.
Change in single digit force - Force sensors - Hand Injuries Group (System application) - 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.
Change from Baseline grip and pinch force at 4 weeks - Hand dynamometer - Hand Injuries Group (System application) - 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.
Change from Baseline perspective hand function at 2 weeks - Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group (System application) - 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.
Change in hand dexterity - Purdue pegboard test - Hand Injuries Group (System application) - 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.
Change from Baseline hand dexterity at 2 weeks - Purdue pegboard test - Hand Injuries Group (System application) - 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.
Change from Baseline perspective hand function at 4 weeks - Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group (System application) - 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.
次要结局
未报告次要终点