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Innovative Hand Rehabilitation System With Synchronized Contralateral Haptic Feedback

Innovative Hand Rehabilitation System With Synchronized Contralateral Haptic Feedback

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07077460
Enrollment
100
Registered
2025-07-22
Start date
2024-10-04
Completion date
2025-10-22
Last updated
2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Elderly

Keywords

Functional near infrared spectroscopy, Parameters of digit force independence, Mirror Visual Feedback, Hand Training System, Hand Dexterity, Synchronized contralateral haptic feedback

Brief 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. 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.

Interventions

DEVICETIPr

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.

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

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

DEVICEGraded-Pressure Haptic Device (Passive press-feedback cushion)

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)

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Minnesota Manual Dexterity Test (MMDT)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.
Hand StrengthBefore 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.
Purdue Pegboard Test (PPT)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.
Oxygenated hemoglobin (HbO)Before and after intervention(test time:40 minutes)The Oxygenated hemoglobin (HbO) was measured while the participants play the game under both conditions
Digit Independence (EN value)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.
Force control abilityBefore 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.

Secondary

MeasureTime frameDescription
Maximum voluntary isometric contraction (MVIC)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

Countries

Taiwan

Contacts

Primary ContactFong-Chin Su, PHD
fcsu@ncku.edu.tw06-2757575

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026