Innovative Hand Rehabilitation System With Synchronized Contralateral Haptic Feedback

National Cheng-Kung University

Status: Enrolling

Conditions: Healthy Elderly

Treatments: Device: Graded-Pressure Haptic Device (Passive press-feedback cushion); Device: Mirror Visual Feedback Device; Device: TIPr; Device: Mirror Visual Feedback Device(Blocked mirror)

Study type: Interventional

Funder types: Other

Identifiers

NCT07077460

113-162

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 3 patient groups

Mirror Visual Feedback Group

Active Comparator group

Description:

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.

Treatment:

Device: Mirror Visual Feedback Device

Device: TIPr

Non-Mirror Visual Feedback Group

Active Comparator group

Description:

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.

Treatment:

Device: Mirror Visual Feedback Device(Blocked mirror)

Device: TIPr

Output-Dependent Cutaneous Pressure Tactile plus Mirror Visual Feedback Group

Experimental group

Description:

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). 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.

Treatment:

Device: Mirror Visual Feedback Device

Device: TIPr

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