Innovative Hand Rehabilitation System With Synchronized C... | NCT07077460

Status Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mirror Visual Feedback Group	Active Comparator	All 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.	Device: TIPr Device: Mirror Visual Feedback Device
Non-Mirror Visual Feedback Group	Active Comparator	All 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.	Device: TIPr Device: Mirror Visual Feedback Device(Blocked mirror)
Output-Dependent Cutaneous Pressure Tactile plus Mirror Visual Feedback Group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Before and after intervention(test time:15 minutes)
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.	Before and after intervention(total test time for all subtest: 10 minutes)
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.	Before and after intervention(total test time for all subtests:25 minutes)
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.	Before and after intervention(test time:40 seconds for each digits)
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.	Before and after intervention(test time: 40 seconds for each digits)

Secondary Outcomes

Measure	Description	Time Frame
Maximum voluntary isometric contraction (MVIC)	Maximum voluntary isometric contraction of each digit is measured for training reference	Every time before the initiation of game(test time:1 seconds for each digit)

Eligibility Module

Name	Role	Phone	Extension	Email
Fong-Chin Su, PHD	Contact	06-2757575	63422	fcsu@ncku.edu.tw

Name	Affiliation	Role
Fong-Chin Su, PHD	Chair Professor	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
National Cheng Kung University	Recruiting	Tainan	Taiwan	701	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25653609	Background	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.
22956850	Background	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.