Ultrasonography-guided Real-time Modular Systems for Hand Therapy

National Cheng-Kung University

Status: Enrolling

Conditions: Patients With Traumatic Hand Injury; Health Adults

Treatments: Other: Biofeedback training

Study type: Interventional

Funder types: Other

Identifiers

NCT06189235

B-ER-111-012

Details and patient eligibility

About

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.

Enrollment: 149 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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149 participants in 5 patient groups

System development: Validation for patients

No Intervention group

Description:

No intervention. The patients will receive one time of MRI and three times of ultrasound evaluation on the injured area, each evaluaitons will be done by two to three days interval.

System development: Building dataset from healthy subjects

No Intervention group

Description:

No intervention. The healthy subjects will receive one time of ultrasound evaluation on the dominant hand, the different part and different axis in dominant hand will be assessed in types of images or films for building the dataset.

System application: Understanding the recovery patterns in patients

No Intervention group

Description:

No intervention. The patients will receive three times of ultrasound evaluation on the injured area and hand function assessments, each evaluaitons will be done by two weeks interval.

System application: Biofeedback training

Experimental group

Description:

The program last for one month. In this program, the patients receive traditional rehabilitation protocol assigned from original hospital or therapist. Also, ultrasound evaluation and hand function assessment will be performed at pre-test, one follow-up test and post-test, which will be done with two weeks interval. For this biofeedback training group, the therapist and patients will be asked to use the hint recommanded by modular system to assist the rehabilitation excepting the traditional routine at least two times a week.

Treatment:

Other: Biofeedback training

System application: Traditional training

No Intervention group

Description:

The program last for one month. In this program, the patients receive traditional rehabilitation protocol assigned from original hospital or therapist. Also, ultrasound evaluation and hand function assessment will be performed at pre-test, one follow-up test and post-test, which will be done with two weeks interval.