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NCT Number: NCT07077460

Innovative Hand Rehabilitation System With Synchronized Contralateral Haptic Feedback

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.

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Key information

Conditions

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University

Tainan, Taiwan, 701

Location status: Recruiting

Location contact

Fong-Chin Su, PHD

CONTACT

[email protected]

06-2757575 ext. 63422

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

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 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)

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.

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

  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.

  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. Dominant hand and non-dominant 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. Dominant hand and non-dominant hand need to be evaluated.

  6. Oxygenated hemoglobin (HbO)

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

    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 of each digit is measured for training reference

Study contacts

Contact information is provided by the study sponsor or research team.

Fong-Chin Su, PHD

CONTACT

[email protected]

06-2757575 ext. 63422

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2025
Registry last updated
Aug 29, 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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