Ultrasonography-guided Real-time Modular Systems for Hand Therapy

Development of Ultrasonography-guided Real-time Intelligent Monitoring, Evaluation and Biofeedback Training Modular Systems for Hand Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Health Adults; Patients With Traumatic Hand Injury
• Intervention / Treatment: Other: Biofeedback training

• Study Type: Interventional
• Enrollment (Estimated): 149
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li-Chieh Kuo, Ph. D.; Phone Number: 5908 886-62353535; Email: jkkuo@mail.ncku.edu.tw

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • Recruiting
    • National Cheng-Kung University Hospital
    • Contact: Li-Chieh Kuo; Phone Number: 5908 886-62353535; Email: jkkuo@mail.ncku.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

【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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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 Intervention: 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 Intervention: 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.
Experimental: 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.	Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in tissue characteristics - Ultrasonography platform - Hand Injuries Group (System development) - 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.	Baseline, 2-3 days after baseline, 4-5 days after baseline
Change from Baseline tissue characteristics at 2-3 days - Ultrasonography platform - Hand Injuries Group (System development) - 2-3 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.	Baseline, 2-3 days after baseline, 4-5 days after baseline
Change from Baseline tissue characteristics at 4-5 days - Ultrasonography platform - Hand Injuries Group (System development) - 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.	Baseline, 2-3 days after baseline, 4-5 days after baseline
Ultrasonography platform - Healthy Group - 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.	Baseline
Change in tissue characteristics - Ultrasonography platform - Hand Injuries Group (System application) - 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.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline tissue characteristics at 2 weeks - Ultrasonography platform - Hand Injuries Group (System application) - 2 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.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline tissue characteristics at 4 weeks - Ultrasonography platform - Hand Injuries Group (System application) - 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.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Change in joint ROM - Goniometer - Hand Injuries Group (System application) - Baseline	The goniometer will be used to measure the range of motion (ROM) in the affected and affected finger.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline joint ROM at 2 weeks - Goniometer - Hand Injuries Group (System application) - 2 weeks after baseline	The goniometer will be used to measure the range of motion (ROM) in the affected and affected finger.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline joint ROM at 4 weeks - Goniometer - Hand Injuries Group (System application) - 4 weeks after baseline	The goniometer will be used to measure the range of motion (ROM) in the affected and affected finger.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Change in single digit force - Force sensors - Hand Injuries Group (System application) - Baseline	A force sensor will be used to collect the single digit force data in affected and unaffected finger.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline single digit force at 2 weeks - Force sensors - Hand Injuries Group (System application) - 2 weeks after baseline	A force sensor will be used to collect the single digit force data in affected and unaffected finger.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline single digit force at 4 weeks - Force sensors - Hand Injuries Group (System application) - 4 weeks after baseline	A force sensor will be used to collect the single digit force data in affected and unaffected finger.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Change in grip and pinch force - Hand dynamometer - Hand Injuries Group (System application) - Baseline	Hand dynamometer will be used to measure the grip strength and pinch strength.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline grip and pinch force at 2 weeks - Hand dynamometer - Hand Injuries Group (System application) - 2 weeks after baseline	Hand dynamometer will be used to measure the grip strength and pinch strength.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline grip and pinch force at 4 weeks - Hand dynamometer - Hand Injuries Group (System application) - 4 weeks after baseline	Hand dynamometer will be used to measure the grip strength and pinch strength.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Change in hand dexterity - Purdue pegboard test - Hand Injuries Group (System application) - Baseline	The Purdue pegboard test will be used to test the unimanual and bimanual manipulation versus hand dexterity.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline hand dexterity at 2 weeks - Purdue pegboard test - Hand Injuries Group (System application) - 2 weeks after baseline	The Purdue pegboard test will be used to test the unimanual and bimanual manipulation versus hand dexterity.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Change from Baseline hand dexterity at 4 weeks - Purdue pegboard test - Hand Injuries Group (System application) - 4 weeks after baseline	The Purdue pegboard test will be used to test the unimanual and bimanual manipulation versus hand dexterity.	Baseline, 2 weeks after baseline, 4 weeks after baseline
Change in perspective hand function - Disabilities of the Arm, Shoulder and Hand - Hand Injuries Group (System application) - 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.	Baseline, 2 weeks after baseline, 4 weeks after baseline
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	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.	Baseline, 2 weeks after baseline, 4 weeks after baseline
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	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.	Baseline, 2 weeks after baseline, 4 weeks after baseline

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Estimated): April 26, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: June 23, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Biofeedback; Hand therapy; Ultrasonography-guided
• Additional Relevant MeSH Terms: Wounds and Injuries; Hand Injuries
• Other Study ID Numbers: B-ER-111-012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No