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StrokeNCT07150325

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

A study testing TIPr, Mirror Visual Feedback Device and Mirror Visual Feedback Device(Blocked mirror) in people with Stroke and Stroke Patients, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Stroke, Stroke Patients
What is being tested?
TIPr, Mirror Visual Feedback Device and Mirror Visual Feedback Device(Blocked mirror)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteTaiwan
Study dates
19 Dec 2024to 19 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Cheng Kung University

    Tainan, 701

Other trials in Taiwan

About this study

Official title: Integration of Force Control Training and Mirror Visual Feedback 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.

Being tested
TIPr, Mirror Visual Feedback Device, Mirror Visual Feedback Device(Blocked mirror)
Keywords
Hand rehabilitation, Finger force control training, Brain activation, Hand dexterity, Hand strength
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TIPrDevice

    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 DeviceDevice

    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.

Study groups in NCT07150325
Study groupRoleWhat they receive
Mirror Visual Feedback GroupExperimentalAll 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.
Receives: Device: TIPr; Device: Mirror Visual Feedback Device
Non-Mirror Visual Feedback GroupActive comparatorAll 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.
Receives: Device: TIPr; Device: Mirror Visual Feedback Device(Blocked mirror)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hand Strength

    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.

    Measured: Before and after intervention(test time:15 minutes)

  2. Purdue Pegboard Test (PPT)

    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)

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

  3. Minnesota Manual Dexterity Test (MMDT)

    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)

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

  4. Digit Independence (EN value)

    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.

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

  5. Force control ability

    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.

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

  6. Oxygenated hemoglobin (HbO)

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

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

Secondary outcomes (1)
  1. Maximum voluntary isometric contraction (MVIC)

    Maximum voluntary isometric contraction (MVIC)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2025
  2. Study start19 Dec 2024
  3. Primary completion19 Jun 2025
  4. Study completion19 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07150325
Sponsor's protocol ID
A-ER-113-229
Status last verified
Aug 2025
First submitted
24 Aug 2025
Last updated
2 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bajaj S, Butler AJ, Drake D, Dhamala M. Brain effective connectivity during motor-imagery and execution following stroke and rehabilitation. Neuroimage Clin. 2015 Jun 28;8:572-82. doi: 10.1016/j.nicl.2015.06.006. eCollection 2015.

    PubMed 26236627
  • Polli A, Moseley GL, Gioia E, Beames T, Baba A, Agostini M, Tonin P, Turolla A. Graded motor imagery for patients with stroke: a non-randomized controlled trial of a new approach. Eur J Phys Rehabil Med. 2017 Feb;53(1):14-23. doi: 10.23736/S1973-9087.16.04215-5. Epub 2016 Jul 21.

    PubMed 27442717
  • Hsu HY, Chen PT, Kuan TS, Yang HC, Shieh SJ, Kuo LC. A Touch-Observation and Task-Based Mirror Therapy Protocol to Improve Sensorimotor Control and Functional Capability of Hands for Patients With Peripheral Nerve Injury. Am J Occup Ther. 2019 Mar/Apr;73(2):7302205020p1-7302205020p10. doi: 10.5014/ajot.2018.027763.

    PubMed 30915963
  • Ehrensberger M, Simpson D, Broderick P, Blake C, Horgan F, Hickey P, O'Reilly J, Monaghan K. Unilateral Strength Training and Mirror Therapy in Patients With Chronic Stroke: A Pilot Randomized Trial. Am J Phys Med Rehabil. 2019 Aug;98(8):657-665. doi: 10.1097/PHM.0000000000001162.

    PubMed 31318745
  • Dodakian L, Campbell Stewart J, Cramer SC. Motor imagery during movement activates the brain more than movement alone after stroke: a pilot study. J Rehabil Med. 2014 Oct;46(9):843-8. doi: 10.2340/16501977-1844.

    PubMed 25182189
  • Rossiter HE, Borrelli MR, Borchert RJ, Bradbury D, Ward NS. Cortical mechanisms of mirror therapy after stroke. Neurorehabil Neural Repair. 2015 Jun;29(5):444-52. doi: 10.1177/1545968314554622. Epub 2014 Oct 17.

    PubMed 25326511
  • Bello UM, Chan CCH, Winser SJ. Task Complexity and Image Clarity Facilitate Motor and Visuo-Motor Activities in Mirror Therapy in Post-stroke Patients. Front Neurol. 2021 Sep 22;12:722846. doi: 10.3389/fneur.2021.722846. eCollection 2021.

    PubMed 34630297
  • Ventoulis I, Gkouma KR, Ventouli S, Polyzogopoulou E. The Role of Mirror Therapy in the Rehabilitation of the Upper Limb's Motor Deficits After Stroke: Narrative Review. J Clin Med. 2024 Dec 20;13(24):7808. doi: 10.3390/jcm13247808.

    PubMed 39768730
  • Arya KN. Underlying neural mechanisms of mirror therapy: Implications for motor rehabilitation in stroke. Neurol India. 2016 Jan-Feb;64(1):38-44. doi: 10.4103/0028-3886.173622.

    PubMed 26754990
  • Formica C, De Salvo S, Muscara N, Bonanno L, Arcadi FA, Lo Buono V, Acri G, Quartarone A, Marino S. Applications of Near Infrared Spectroscopy and Mirror Therapy for Upper Limb Rehabilitation in Post-Stroke Patients: A Brain Plasticity Pilot Study. J Clin Med. 2024 Nov 4;13(21):6612. doi: 10.3390/jcm13216612.

    PubMed 39518751
  • Hamzei F, Lappchen CH, Glauche V, Mader I, Rijntjes M, Weiller C. Functional plasticity induced by mirror training: the mirror as the element connecting both hands to one hemisphere. Neurorehabil Neural Repair. 2012 Jun;26(5):484-96. doi: 10.1177/1545968311427917. Epub 2012 Jan 13.

    PubMed 22247501
  • Jaafar N, Che Daud AZ, Ahmad Roslan NF, Mansor W. Mirror Therapy Rehabilitation in Stroke: A Scoping Review of Upper Limb Recovery and Brain Activities. Rehabil Res Pract. 2021 Dec 31;2021:9487319. doi: 10.1155/2021/9487319. eCollection 2021.

    PubMed 35003808
  • Bello UM, Winser SJ, Chan CCH. Role of kinaesthetic motor imagery in mirror-induced visual illusion as intervention in post-stroke rehabilitation. Rev Neurosci. 2020 Aug 27;31(6):659-674. doi: 10.1515/revneuro-2019-0106.

    PubMed 32229682
  • Low E, Crewther SG, Ong B, Perre D, Wijeratne T. Compromised Motor Dexterity Confounds Processing Speed Task Outcomes in Stroke Patients. Front Neurol. 2017 Sep 21;8:484. doi: 10.3389/fneur.2017.00484. eCollection 2017.

    PubMed 28983276
  • Ao D, Song R, Tong KY. Sensorimotor control of tracking movements at various speeds for stroke patients as well as age-matched and young healthy subjects. PLoS One. 2015 Jun 1;10(6):e0128328. doi: 10.1371/journal.pone.0128328. eCollection 2015.

    PubMed 26030289

Questions about this trial

What is this clinical trial studying?

A study testing TIPr, Mirror Visual Feedback Device and Mirror Visual Feedback Device(Blocked mirror) in people with Stroke and Stroke Patients, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hand Strength (time frame: Before and after intervention(test time:15 minutes)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07150325, which also lists 89 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.

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Clinical Trial NCT07150325 | AzTrials