Innovative Hand Rehabilitation System With Synchronized Contralateral Haptic Feedback

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorNational Cheng-Kung University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Mirror Visual Feedback GroupActive comparator 2 interventions
Group B: Non-Mirror Visual Feedback GroupActive comparator 2 interventions
Group C: Output-Dependent Cutaneous Pressure Tactile plus Mirror Visual Feedback GroupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Before and after intervention(test time:40 seconds for each digits)

Secondary outcomes

1

Maximum voluntary isometric contraction (MVIC)

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

Time frame
Every time before the initiation of game(test time:1 seconds for each digit)

Other outcomes

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