Innovative Hand Rehabilitation System With Synchronized Contralateral Haptic Feedback

Overview

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

• Device TIPr
  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.
• Device Mirror Visual Feedback Device
  A box with two compartments through a partition with two mirrors installed on each side, which is applied in Mirror therapy.
• Device Mirror Visual Feedback Device(Blocked mirror)
  Different from Mirror Visual Feedback Device in MVF group, the mirror was blocked by black curtain or paperboard.
• Device Graded-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)

Primary outcome measures

• Hand Strength [Time frame: Before and after intervention(test time:15 minutes)]
• Purdue Pegboard Test (PPT) [Time frame: Before and after intervention(total test time for all subtest: 10 minutes)]
• Minnesota Manual Dexterity Test (MMDT) [Time frame: Before and after intervention(total test time for all subtests:25 minutes)]
• Digit Independence (EN value) [Time frame: Before and after intervention(test time:40 seconds for each digits)]
• Force control ability [Time frame: Before and after intervention(test time: 40 seconds for each digits)]
• Oxygenated hemoglobin (HbO) [Time frame: Before and after intervention(test time:40 minutes)]

Secondary outcome measures (1)

• Maximum voluntary isometric contraction (MVIC) [Time frame: Every time before the initiation of game(test time:1 seconds for each digit)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Taiwan · 1 center

• National Cheng Kung University — Tainan

Publications

• 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. PMID 25653609
• 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. PMID 22956850
• Kim MY, Kwon H, Yang TH, Kim K. Vibration Alert to the Brain: Evoked and Induced MEG Responses to High-Frequency Vibrotactile Stimuli on the Index Finger of Dominant and Non-dominant Hand. Front Hum Neurosci. 2020 Nov 5;14:576082. doi: 10.3389/fnhum.2020.576082. eCollection 2020. PMID 33250728
• Demain S, Metcalf CD, Merrett GV, Zheng D, Cunningham S. A narrative review on haptic devices: relating the physiology and psychophysical properties of the hand to devices for rehabilitation in central nervous system disorders. Disabil Rehabil Assist Technol. 2013 May;8(3):181-9. doi: 10.3109/17483107.2012.697532. Epub 2012 Jul 16. PMID 22794937
• Pacheco-Barrios K, Ortega-Marquez J, Fregni F. Haptic Technology: Exploring Its Underexplored Clinical Applications-A Systematic Review. Biomedicines. 2024 Dec 10;12(12):2802. doi: 10.3390/biomedicines12122802. PMID 39767709
• Dickmann T, Wilhelm NJ, Glowalla C, Haddadin S, van der Smagt P, Burgkart R. An Adaptive Mechatronic Exoskeleton for Force-Controlled Finger Rehabilitation. Front Robot AI. 2021 Sep 30;8:716451. doi: 10.3389/frobt.2021.716451. eCollection 2021. PMID 34660703
• Sengupta P, Lakshminarayanan K. Motor imagery of finger movements: Effects on cortical and muscle activities. Behav Brain Res. 2024 Aug 5;471:115100. doi: 10.1016/j.bbr.2024.115100. Epub 2024 Jun 7. PMID 38852744
• Dodakian L, Campbell Stewart J, Cramer SC. Motor imagery during movement activates the brain more than movement alone after stroke: a pilot study. J Rehabil Med. 2014 Oct;46(9):843-8. doi: 10.2340/16501977-1844. PMID 25182189

Identifiers

NCT: NCT07077460 · 113-162

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗