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Healthy ElderlyNCT07077460

Innovative Hand Rehabilitation System With Synchronized Contralateral Haptic Feedback

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

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Previous studies have found that graded motor imagery (GMI) training can provide continuous activation of the cerebral cortex compared to traditional rehabilitation therapy. One of the steps in this strategy, mirror therapy, has also been widely used in the clinical treatment of hemiplegic patients. Read more about this study

Who is it for?
Ages 60 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Elderly
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
100 participants
Where
1 siteTaiwan
Study dates
4 Oct 2024to 22 Oct 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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 60 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age ranged from 20-80 years old
  • Without past medical history of musculoskeletal or neurological disorders that would affect muscle control ability or cause sensory abnormalities
  • Normal cognitive function to understand and follow the instructions
  • Able to understand Chinese, English, or Taiwanese language

Who cannot join

  • With a history of hand-related surgeries
  • With a history of neuromuscular diseases or degenerative arthritis
  • With a history of brain injury
  • With a history of taking psychiatric medications
  • Unable to understand instructions, or have cognitive impairments
  • With a history of physical disabilities (Loss of body parts) or taking relevant medications, including heart disease, peripheral arterial disease, respiratory system diseases, dialysis, unresolved upper extremity injury, or highly addicted to smoking or alcohol

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fong-Chin Su, PHD contact

06-2757575 ext. 63422

fcsu@ncku.edu.tw

Taiwan1 site, 1 recruiting
  • National Cheng Kung University

    Tainan, Taiwan, 701

    Fong-Chin Su, PHD, 06-2757575 ext. 63422, fcsu@ncku.edu.tw

    Recruiting

Other trials in Taiwan

About this study

Previous studies have found that graded motor imagery (GMI) training can provide continuous activation of the cerebral cortex compared to traditional rehabilitation therapy. One of the steps in this strategy, mirror therapy, has also been widely used in the clinical treatment of hemiplegic patients. Also, comparing with traditional rehabilitation treatments, mirror therapy can continuously provide cortical activation. Besides, several studies indicated that game-based interventions contribute to brain activation in the elderly due to their interest can improve users' motivation in the training program execution. In addition, force control training has positive effects on hand dexterity, and specific doses of motor control training not only improve motor function but also have positive effects on brain function.

Currently, hand function training primarily focuses on range of motion, strength, and hand function, although there is comparatively less emphasis on enhancing both force control and brain function. Moreover, studies related to mirror therapy has primarily focused on the execution of functional movements, but has not explored whether hand strength control training can achieve the same training effects on the affected or non-dominant side through the concept of mirror therapy. Furthermore, the effects of combining a hand strength control system with a synchronous contralateral clip-on force feedback device on brain activation and hand function have not yet been studied. Therefore, this study aimed to investigate the effects of integration a finger force control training system with synchronous contralateral force feedback and mirror visual feedback device on brain activation and hand function, aiming to develop a clinically applicable hand rehabilitation system. Additionally, visual feedback from force control training in our study is through the hints displayed virtually on the game interface of the tablet, which were represented as the height of the targets, not as typical as actual movement-based mirror therapy or task-based mirror therapy.

Therefore, the purpose of the study is to understand the differences among training effects of integrating Graded-Pressure Haptic Device-TiPR closed-loop system and MVF; MVF and force control training, as well as isolated force control training, and to explore the training effects on hand strength, hand function and brain activation.

Conditions
Healthy Elderly
Being tested
TIPr, Mirror Visual Feedback Device, Mirror Visual Feedback Device(Blocked mirror), Graded-Pressure Haptic Device (Passive press-feedback cushion)
Keywords
Functional near infrared spectroscopy, Parameters of digit force independence, Mirror Visual Feedback, Hand Training System, Hand Dexterity, Synchronized contralateral haptic feedback

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 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.

  • Graded-Pressure Haptic Device (Passive press-feedback cushion)Device

    A passive press-feedback cushion (Graded-Pressure Haptic Device) would deliver force pulses to the subjects' non-dominant fingertips in synchrony with the TiPR game's force output (matched amplitude)

Study groups in NCT07077460
Study groupRoleWhat they receive
Mirror Visual Feedback GroupActive comparatorAll the subjects were asked to use their dominant hands to operate the hand training system (TIPr) and place their non-dominant hands 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 to reach the target force value. When the dominant hand 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 the non-dominant hand performing the same task as the dominant hand. Subjects was instructed not to move their non-dominant hand voluntarily.
Receives: Device: TIPr; Device: Mirror Visual Feedback Device
Non-Mirror Visual Feedback GroupActive comparatorAll the subjects were asked to use their dominant hands to operate the hand training system (TIPr) and place their non-dominant 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 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 non-dominant hand performing the same task as the dominant hand without mirror visual feedback. Subjects was instructed not to move their non-dominant hand voluntarily.
Receives: Device: TIPr; Device: Mirror Visual Feedback Device(Blocked mirror)
Output-Dependent Cutaneous Pressure Tactile plus Mirror Visual Feedback GroupExperimentalAll the subjects were asked to use their dominant hands to operate the hand training system (TIPr) and place their non-dominant hands behind the mirror on the other hand training system (TIPr). Moreover, graded cutaneous pressure feedback, delivered via a novel Graded-Pressure Haptic Device would be applied on non-dominant fingers. When the dominant hand started to play the game, the force exerted by the fingertips will be presented on the tablet, and the mirror would show the mirrored image of force output level. Subjects were instructed to keep their eyes contacts on the mirrored-image and simultaneously "imagine" that the non-dominant hand performing the same task as the dominant hand. At the same time, subjects would additionally received force pulses on the non-dominant fingertip in synchrony with the TiPR game's force output (matched amplitude) to add tactile feedback. Subjects was instructed not to move their non-dominant hand voluntarily.
Receives: Device: TIPr; Device: Mirror Visual Feedback Device; Device: Graded-Pressure Haptic Device (Passive press-feedback cushion)

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.

    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 dominant hand and non-dominant hand). Each subtest test for three times.

    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.

    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. Dominant hand and non-dominant 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. Dominant hand and non-dominant 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)

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

    Maximum voluntary isometric contraction of each digit is measured for training reference

    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 posted22 Jul 2025
  2. Study start4 Oct 2024
  3. Primary completion22 Oct 2025 (estimated)
  4. Study completion22 Oct 2025 (estimated)

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects would use their dominant hand to operate the hand training system (Tipr), and according to the game instructions prompted by the tablet screen, slowly press the corresponding finger to the evaluation system to reach the target force value. At the same time, the subjects were instructed to place their non-dominant hand behind the mirror device and place it on another hand training system (Tipr). When the dominant hand starts to execute the game instructions, the force exerted by the fingertips will be presented on the tablet in the form of a game task screen. At the same time, a mirror or other device that can provide a mirror will be used to project the mirrored game screen to the developing device on non-dominant hand side. At the same time, subjects would get the feedback from only mirror visual feedback or both mirror visual feedback and Graded-Pressure Haptic feedback device or no other feedback, respectively for each group, during performing the force control training.
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07077460
Sponsor's protocol ID
113-162
Status last verified
Aug 2025
First submitted
11 Jul 2025
Last updated
29 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kim J, Muller KR, Chung YG, Chung SC, Park JY, Bulthoff HH, Kim SP. Distributed functions of detection and discrimination of vibrotactile stimuli in the hierarchical human somatosensory system. Front Hum Neurosci. 2015 Jan 21;8:1070. doi: 10.3389/fnhum.2014.01070. eCollection 2014.

    PubMed 25653609
  • Mendez-Balbuena I, Manjarrez E, Schulte-Monting J, Huethe F, Tapia JA, Hepp-Reymond MC, Kristeva R. Improved sensorimotor performance via stochastic resonance. J Neurosci. 2012 Sep 5;32(36):12612-8. doi: 10.1523/JNEUROSCI.0680-12.2012.

    PubMed 22956850
  • Kim MY, Kwon H, Yang TH, Kim K. Vibration Alert to the Brain: Evoked and Induced MEG Responses to High-Frequency Vibrotactile Stimuli on the Index Finger of Dominant and Non-dominant Hand. Front Hum Neurosci. 2020 Nov 5;14:576082. doi: 10.3389/fnhum.2020.576082. eCollection 2020.

    PubMed 33250728
  • Demain S, Metcalf CD, Merrett GV, Zheng D, Cunningham S. A narrative review on haptic devices: relating the physiology and psychophysical properties of the hand to devices for rehabilitation in central nervous system disorders. Disabil Rehabil Assist Technol. 2013 May;8(3):181-9. doi: 10.3109/17483107.2012.697532. Epub 2012 Jul 16.

    PubMed 22794937
  • Pacheco-Barrios K, Ortega-Marquez J, Fregni F. Haptic Technology: Exploring Its Underexplored Clinical Applications-A Systematic Review. Biomedicines. 2024 Dec 10;12(12):2802. doi: 10.3390/biomedicines12122802.

    PubMed 39767709
  • Dickmann T, Wilhelm NJ, Glowalla C, Haddadin S, van der Smagt P, Burgkart R. An Adaptive Mechatronic Exoskeleton for Force-Controlled Finger Rehabilitation. Front Robot AI. 2021 Sep 30;8:716451. doi: 10.3389/frobt.2021.716451. eCollection 2021.

    PubMed 34660703
  • Sengupta P, Lakshminarayanan K. Motor imagery of finger movements: Effects on cortical and muscle activities. Behav Brain Res. 2024 Aug 5;471:115100. doi: 10.1016/j.bbr.2024.115100. Epub 2024 Jun 7.

    PubMed 38852744
  • 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
  • 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
  • Kara OK, Yardimci BN, Sahin S, Orhan C, Livanelioglu A, Soylu AR. Combined Effects of Mirror Therapy and Exercises on the Upper Extremities in Children with Unilateral Cerebral Palsy: A Randomized Controlled Trial. Dev Neurorehabil. 2020 May;23(4):253-264. doi: 10.1080/17518423.2019.1662853. Epub 2019 Sep 13.

    PubMed 31514564
  • 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
  • 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
  • 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
  • Gowda AS, Memon AN, Bidika E, Salib M, Rallabhandi B, Fayyaz H. Investigating the Viability of Motor Imagery as a Physical Rehabilitation Treatment for Patients With Stroke-Induced Motor Cortical Damage. Cureus. 2021 Mar 19;13(3):e14001. doi: 10.7759/cureus.14001.

    PubMed 33884242
  • Choy CS, Fang Q, Neville K, Ding B, Kumar A, Mahmoud SS, Gu X, Fu J, Jelfs B. Virtual reality and motor imagery for early post-stroke rehabilitation. Biomed Eng Online. 2023 Jul 5;22(1):66. doi: 10.1186/s12938-023-01124-9.

    PubMed 37407988

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 Healthy Elderly, 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: looking for participants now, as of the sponsor's last update on 29 Aug 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Fong-Chin Su, PHD (06-2757575 ext. 63422, fcsu@ncku.edu.tw), or a site near the patient. 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 NCT07077460, which also lists 83 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 29 Aug 2025.

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