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

NCT ID: NCT07150325

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-19
• Study Completion Date: 2025-06-19

Brief Summary

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.

Conditions

Stroke; Stroke Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mirror Visual Feedback Group

All the stroke patients were asked to use their unaffected hand to operate the hand training system (TIPr) and place their affected hand behind the mirror on the other hand training system (TIPr). According to the game instructions shown on the tablet screen, they should slowly press the evaluation system with the corresponding fingers of their unaffected hand to reach the target force value. When the unaffected hands started to cooperate with the game instructions, the force exerted by the fingertips will be presented on the tablet, and the mirror would show the mirrored (reflected) image of force output level. The subjects were instructed to keep their eyes contacts on the reflected image from the mirror and simultaneously "imagine" that their affected hand performing the same task as the unaffected hand. Subjects was instructed not to move their affected hand voluntarily.

Group Type: EXPERIMENTAL

TIPr

Intervention Type: 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

Intervention Type: DEVICE

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

Non-Mirror Visual Feedback Group

All the subjects were asked to use their unaffected hands to operate the hand training system (TIPr) and place their affected hands behind the mirror on the other hand training system. According to the game instructions shown on the tablet screen, they should slowly press the evaluation system with the corresponding fingers of their unaffected hand to reach the target force value. When the dominant hand starts to cooperate with the game instructions, the force exerted by the fingertips will be presented on the tablet. Different from MVF group, the mirror would be covered. The subjects were instructed to keep their eyes contact on the tablet and imagine the affected hand performing the same task as the unaffected hand without mirror visual feedback. Subjects was instructed not to move their affected hand voluntarily.

Group Type: ACTIVE_COMPARATOR

TIPr

Intervention Type: 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(Blocked mirror)

Intervention Type: DEVICE

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

Interventions

TIPr

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.

Intervention Type: DEVICE

Mirror Visual Feedback Device

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

Intervention Type: DEVICE

Mirror Visual Feedback Device(Blocked mirror)

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fong Chin Su

Chair Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fong-Chin Su, PHD

Role: PRINCIPAL_INVESTIGATOR

Chair Professor

Locations

National Cheng Kung University

Tainan City, , Taiwan

Countries

Taiwan

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Other Identifiers

A-ER-113-229

Identifier Type: -

Identifier Source: org_study_id