Ultrasonography-guided Real-time Modular Systems for Hand Therapy
NCT ID: NCT06189235
Last Updated: 2024-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
149 participants
INTERVENTIONAL
2023-06-28
2024-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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System development: Validation for patients
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.
No interventions assigned to this group
System development: Building dataset from healthy subjects
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.
No interventions assigned to this group
System application: Understanding the recovery patterns in patients
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.
No interventions assigned to this group
System application: Biofeedback training
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.
Biofeedback training
The target of additional biofeedback training is to provide hints which are related to the essential aspects during hand therapy such as the stress on the tissue and the distance of tendon gliding.
System application: Traditional training
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.
No interventions assigned to this group
Interventions
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Biofeedback training
The target of additional biofeedback training is to provide hints which are related to the essential aspects during hand therapy such as the stress on the tissue and the distance of tendon gliding.
Eligibility Criteria
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Inclusion Criteria
* Able to do active motion and resistive activities
* Understand and cooperate the experiment
* No history of traumatic hand injury and other hand related conditions
* Understand and cooperate the experiment
Exclusion Criteria
* Combined with other central or peripheral nerve deficits which cause difficulty in movements
【Healthy subjects】
* Burn, amputees or has history of arthritis
* Combined with other central or peripheral nerve deficits which cause difficulty in movements
20 Years
ALL
Yes
Sponsors
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National Cheng-Kung University Hospital
OTHER
Responsible Party
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Locations
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National Cheng-Kung University Hospital
Tainan City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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B-ER-111-012
Identifier Type: -
Identifier Source: org_study_id
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