Clinical trial NCT06189235: Ultrasonography-guided Real-time Modular Systems for Hand Therapy
Official title: Development of Ultrasonography-guided Real-time Intelligent Monitoring, Evaluation and Biofeedback Training Modular Systems for Hand Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Adults
Patients With Traumatic Hand Injury
Keywords: Ultrasonography-guided
Biofeedback
Hand therapy
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2024-01-03
Enrollment: 149
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 【Patients】

Inclusion Criteria:

* 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:

* 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

Primary outcomes:
measure: Change in tissue characteristics - Ultrasonography platform - Hand Injuries Group (System development) - Baseline
timeFrame: Baseline, 2-3 days after baseline, 4-5 days after baseline
measure: Change from Baseline tissue characteristics at 2-3 days - Ultrasonography platform - Hand Injuries Group (System development) - 2-3 days after baseline
timeFrame: Baseline, 2-3 days after baseline, 4-5 days after baseline
measure: Change from Baseline tissue characteristics at 4-5 days - Ultrasonography platform - Hand Injuries Group (System development) - 4-5 days after baseline
timeFrame: Baseline, 2-3 days after baseline, 4-5 days after baseline
measure: Ultrasonography platform - Healthy Group - Baseline
timeFrame: Baseline
measure: Change in tissue characteristics - Ultrasonography platform - Hand Injuries Group (System application) - Baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Change from Baseline tissue characteristics at 2 weeks - Ultrasonography platform - Hand Injuries Group (System application) - 2 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Change from Baseline tissue characteristics at 4 weeks - Ultrasonography platform - Hand Injuries Group (System application) - 4 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Change in joint ROM - Goniometer - Hand Injuries Group (System application) - Baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Change from Baseline joint ROM at 2 weeks - Goniometer - Hand Injuries Group (System application) - 2 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Change from Baseline joint ROM at 4 weeks - Goniometer - Hand Injuries Group (System application) - 4 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Change in single digit force - Force sensors - Hand Injuries Group (System application) - Baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Change from Baseline single digit force at 2 weeks - Force sensors - Hand Injuries Group (System application) - 2 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Change from Baseline single digit force at 4 weeks - Force sensors - Hand Injuries Group (System application) - 4 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Change in grip and pinch force - Hand dynamometer - Hand Injuries Group (System application) - Baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Change from Baseline grip and pinch force at 2 weeks - Hand dynamometer - Hand Injuries Group (System application) - 2 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Change from Baseline grip and pinch force at 4 weeks - Hand dynamometer - Hand Injuries Group (System application) - 4 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Change in hand dexterity - Purdue pegboard test - Hand Injuries Group (System application) - Baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Change from Baseline hand dexterity at 2 weeks - Purdue pegboard test - Hand Injuries Group (System application) - 2 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Change from Baseline hand dexterity at 4 weeks - Purdue pegboard test - Hand Injuries Group (System application) - 4 weeks after baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: Change in perspective hand function - Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group (System application) - Baseline
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: 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
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
measure: 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
timeFrame: Baseline, 2 weeks after baseline, 4 weeks after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng-Kung University Hospital
Study officials:
References: