Integration of Force Control Training and Mirror Visual Feedback on Stroke Patients on Brain Activation and Hand Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Minnesota Manual Dexterity Test (MMDT)
研究概览
简要总结
Global elderly population continues to grow. Among the diseases caused by aging, stroke accounts for the highest incidence, and the number of stroke patient is increasing year-by-year. Stroke is a common central nervous system disorder, including infarcts and hemorrhagic strokes. It develops rapidly and causes a wide range of neurological deficits. Clinical manifestations vary depending on the location of the brain damage. Common features include hemiplegia and paresthesia, which may be accompanied by incoordination and speech impairments. This leads to decreased independence in daily life, negatively impacting the quality of life and causing stress for patients and their families.
Hand movements are crucial for 70% of daily activities, yet only approximately 15% of patients can regain normal hand movements. Therefore, hand movement restoration is a key focus of rehabilitation. Previous studies have found that finger pressure training using a hand force control system (Tipr) can improve hand and cognitive function in older adults. However, no studies have examined the effectiveness of this hand force control system in the hemiplegic hand of stroke patients. Mirror therapy, a hand training technique used in stroke rehabilitation, has been shown to improve the function of the hemiplegic limb in stroke patients. However, there are currently no studies examining the application of force control in mirror therapy. Therefore, this study aims to explore and develop a hand rehabilitation method that combines the different compression patterns provided by the hand training system (Tipr) with a mirror training device. By incorporating the mirror's visual feedback of the contralateral limb, the application of the hand training system will be expanded. Non-invasive near-infrared spectroscopy (fNIRs) will be used to assess user brain activation and changes in hand function. This study will investigate user feedback on this rehabilitation method and explore whether force control training can induce bilateral brain interactions and their impact on hand function. The goal is to commercialize this innovative treatment approach for clinical evaluation and training applications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Age 20 or older and not participating in any other experimental studies during the study period.
- •2. Patients diagnosed with unilateral cerebral embolism or intracerebral hemorrhage.
- •3. Scores on the Fogel-Meyer Motor Scale-Upper Limb between 20 and 66 (scores indicate poor to full motor function on the affected upper limb), or Brunnstrom stage II or higher for both the proximal and distal upper limbs.
- •4. Mini-Mental State Examination (MMSE) scores, based on educational level: at least 16 for those with no education, at least 21 for those with elementary school education, and at least 24 for those with junior high school education or higher.
排除标准
- •1. Patients with unilateral cerebral hemisphere damage as diagnosed by CT scan.
- •2. Upper limb joint deformity, history of complex or major hand surgery on one hand, or severe hand arthritis.
- •3. Any visual or hearing impairment that would affect experimental performance or prevent compliance with experimental instructions.
- •4. Patients with severe hemispheric neglect.
- •5. Aphasia, which makes it difficult to understand or respond to multiple written or spoken instructions.
- •6. Other factors that may affect participation in the experiment, such as body part loss.
研究组 & 干预措施
Mirror Visual Feedback Group
All the stroke patients were asked to use their unaffected hand to operate the hand training system (TIPr) and place their affected hand 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 of their unaffected hand to reach the target force value. When the unaffected hands 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 their affected hand performing the same task as the unaffected hand. Subjects was instructed not to move their affected hand voluntarily.
干预措施: TIPr (Device)
Mirror Visual Feedback Group
All the stroke patients were asked to use their unaffected hand to operate the hand training system (TIPr) and place their affected hand 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 of their unaffected hand to reach the target force value. When the unaffected hands 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 their affected hand performing the same task as the unaffected hand. Subjects was instructed not to move their affected hand voluntarily.
干预措施: Mirror Visual Feedback Device (Device)
Non-Mirror Visual Feedback Group
All the subjects were asked to use their unaffected hands to operate the hand training system (TIPr) and place their affected 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 of their unaffected hand 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 affected hand performing the same task as the unaffected hand without mirror visual feedback. Subjects was instructed not to move their affected hand voluntarily.
干预措施: TIPr (Device)
Non-Mirror Visual Feedback Group
All the subjects were asked to use their unaffected hands to operate the hand training system (TIPr) and place their affected 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 of their unaffected hand 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 affected hand performing the same task as the unaffected hand without mirror visual feedback. Subjects was instructed not to move their affected hand voluntarily.
干预措施: Mirror Visual Feedback Device(Blocked mirror) (Device)
结局指标
主要结局
Minnesota Manual Dexterity Test (MMDT)
时间窗: Before and after intervention(total test time for all subtests:25 minutes)
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. (Adjustable based on stroke patients' hand function)
Hand Strength
时间窗: Before and after intervention(test time:15 minutes)
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.(Adjustable based on stroke patients' hand function) Unaffected hand and unaffected hand need to be evaluated.
Purdue Pegboard Test (PPT)
时间窗: Before and after intervention(total test time for all subtest: 10 minutes)
Assess the manual dexterity and coordination for one and both hands, including one hand, two hand and assembly subtest. ( Test for affected hand and unaffected hand). Each subtest test for three times. (Adjustable based on stroke patients' hand function)
Digit Independence (EN value)
时间窗: Before and after intervention(test time:40 seconds for each digits)
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. Unaffected hand and unaffected hand need to be evaluated.
Force control ability
时间窗: Before and after intervention(test time: 40 seconds for each digits)
Subjects will be asked to track the target force and presses task digit to fit the target line as accurately as possible. Unaffected hand and unaffected hand need to be evaluated.
Oxygenated hemoglobin (HbO)
时间窗: Before and after intervention(test time:40 minutes or more)
The Oxygenated hemoglobin (HbO) was measured while the participants play the game under both conditions
次要结局
- Maximum voluntary isometric contraction (MVIC)(Every time before the initiation of game(test time:1 seconds for each digit))
研究者
Fong Chin Su
Chair Professor
National Cheng-Kung University Hospital