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NCT Number: NCT07150325

Combination of Force Control Training and Mirror Visual Feedback Device on Stroke Patients on Brain Activation and Hand Function

Global elderly population continues to grow. Among the diseases caused by aging, stroke accounts for the highest incidence, and the number of stroke patient is increasing year-by-year. Stroke is a common central nervous system disorder, including infarcts and hemorrhagic strokes. It develops rapidly and causes a wide range of neurological deficits. Clinical manifestations vary depending on the location of the brain damage. Common features include hemiplegia and paresthesia, which may be accompanied by incoordination and speech impairments. This leads to decreased independence in daily life, negatively impacting the quality of life and causing stress for patients and their families.

Hand movements are crucial for 70% of daily activities, yet only approximately 15% of patients can regain normal hand movements. Therefore, hand movement restoration is a key focus of rehabilitation. Previous studies have found that finger pressure training using a hand force control system (Tipr) can improve hand and cognitive function in older adults. However, no studies have examined the effectiveness of this hand force control system in the hemiplegic hand of stroke patients. Mirror therapy, a hand training technique used in stroke rehabilitation, has been shown to improve the function of the hemiplegic limb in stroke patients. However, there are currently no studies examining the application of force control in mirror therapy. Therefore, this study aims to explore and develop a hand rehabilitation method that combines the different compression patterns provided by the hand training system (Tipr) with a mirror training device. By incorporating the mirror's visual feedback of the contralateral limb, the application of the hand training system will be expanded. Non-invasive near-infrared spectroscopy (fNIRs) will be used to assess user brain activation and changes in hand function. This study will investigate user feedback on this rehabilitation method and explore whether force control training can induce bilateral brain interactions and their impact on hand function. The goal is to commercialize this innovative treatment approach for clinical evaluation and training applications.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Patients Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University

Tainan, 701, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Age 20 or older and not participating in any other experimental studies during the study period.
  • 2. Patients diagnosed with unilateral cerebral embolism or intracerebral hemorrhage.
  • 3. Scores on the Fogel-Meyer Motor Scale-Upper Limb between 20 and 66 (scores indicate poor to full motor function on the affected upper limb), or Brunnstrom stage II or higher for both the proximal and distal upper limbs.
  • 4. Mini-Mental State Examination (MMSE) scores, based on educational level: at least 16 for those with no education, at least 21 for those with elementary school education, and at least 24 for those with junior high school education or higher.

Exclusion criteria

  • 1. Patients with unilateral cerebral hemisphere damage as diagnosed by CT scan.
  • 2. Upper limb joint deformity, history of complex or major hand surgery on one hand, or severe hand arthritis.
  • 3. Any visual or hearing impairment that would affect experimental performance or prevent compliance with experimental instructions.
  • 4. Patients with severe hemispheric neglect.
  • 5. Aphasia, which makes it difficult to understand or respond to multiple written or spoken instructions.
  • 6. Other factors that may affect participation in the experiment, such as body part loss.

Treatment and study plan

TIPr

Device

TIPr is a second-generation device, which is originated from Pressing Evaluation and Training System (PETs), developed by NCKU Motion Analysis Lab. This 2nd generation device is a home-based training device, which equipped with single-axis force sensors and displayed visual feedback through a tablet advantages.

Mirror Visual Feedback Device

Device

A box with two compartments through a partition with two mirrors installed on each side, which is commonly applied in Mirror therapy.

Mirror Visual Feedback Device(Blocked mirror)

Device

Different from Mirror Visual Feedback Device in MVF group, the mirror was blocked by black curtain or paperboard.

Primary outcomes

  1. Hand Strength

    Time frame: Before and after intervention(test time:15 minutes)

    Handgrip strength and pinch strength was measured respectively. JAMAR Grip Hand Dynamometer and JAMAR Hydraulic Pinch Gauge were used for the apparatus for force measurement. Pinch strength was divided into lateral pinch, tip pinch and tripod pinch. Each test will test for three times and get the average results.(Adjustable based on stroke patients' hand function) Unaffected hand and unaffected hand need to be evaluated.

  2. Purdue Pegboard Test (PPT)

    Time frame: Before and after intervention(total test time for all subtest: 10 minutes)

    Assess the manual dexterity and coordination for one and both hands, including one hand, two hand and assembly subtest. ( Test for affected hand and unaffected hand). Each subtest test for three times. (Adjustable based on stroke patients' hand function)

  3. Minnesota Manual Dexterity Test (MMDT)

    Time frame: Before and after intervention(total test time for all subtests:25 minutes)

    Assess the eye-hand coordination ability and manual dexterity. MMDT was divided into: Turning, Placing, One hand Turning and Placing, Two hand Turning and Placing, Displacing. (Adjustable based on stroke patients' hand function)

  4. Digit Independence (EN value)

    Time frame: Before and after intervention(test time:40 seconds for each digits)

    The force independence of each digit is collected from the data during force tracking test in evaluation session. The parameter of force independence is an index of five digits overall enslaving presented as EN value. Unaffected hand and unaffected hand need to be evaluated.

  5. Force control ability

    Time frame: Before and after intervention(test time: 40 seconds for each digits)

    Subjects will be asked to track the target force and presses task digit to fit the target line as accurately as possible. Unaffected hand and unaffected hand need to be evaluated.

  6. Oxygenated hemoglobin (HbO)

    Time frame: Before and after intervention(test time:40 minutes or more)

    The Oxygenated hemoglobin (HbO) was measured while the participants play the game under both conditions

Secondary outcomes

  1. Maximum voluntary isometric contraction (MVIC)

    Time frame: Every time before the initiation of game(test time:1 seconds for each digit)

    Maximum voluntary isometric contraction (MVIC)

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

Integration of Force Control Training and Mirror Visual Feedback on Stroke Patients on Brain Activation and Hand Function

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 2, 2025
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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