Innovative Hand Rehabilitation System With Synchronized Contralateral Haptic Feedback

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (1)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Тайвань · 1 центр

• National Cheng Kung University — Tainan

Публикации

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Идентификаторы

NCT: NCT07077460 · 113-162

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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