NCT06189235

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

June 28, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

January 3, 2024

Status Verified

June 1, 2023

Enrollment Period

10 months

First QC Date

June 23, 2023

Last Update Submit

December 19, 2023

Conditions

Health AdultsPatients With Traumatic Hand Injury

Keywords

Ultrasonography-guidedBiofeedbackHand therapy

Outcome Measures

Primary Outcomes (22)

  • 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

Study Arms (5)

System development: Validation for patients

NO INTERVENTION

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

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

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

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

System application: Traditional training

NO INTERVENTION

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.

Interventions

Biofeedback trainingOTHER

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: Biofeedback training

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Burn, amputees or has history of arthritis
  • Combined with other central or peripheral nerve deficits which cause difficulty in movements
  • 【Healthy subjects】
  • No history of traumatic hand injury and other hand related conditions
  • Understand and cooperate the experiment
  • Burn, amputees or has history of arthritis
  • Combined with other central or peripheral nerve deficits which cause difficulty in movements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

Central Study Contacts

Li-Chieh Kuo, Ph. D.

CONTACT

886-62353535jkkuo@mail.ncku.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2023

First Posted

January 3, 2024

Study Start

June 28, 2023

Primary Completion

April 26, 2024

Study Completion

July 31, 2024

Last Updated

January 3, 2024

Record last verified: 2023-06

Locations

TW(1)