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研究生：	李志明 Li, Chih-Ming
論文名稱：	開發新式吞嚥障礙評估與治療儀 Development of Novel Device for Evaluation and Management of Dysphagia
指導教授：	陳家進 Chen, Jia-Jin Jason
學位類別：	博士 Doctor
系所名稱：	工學院 - 生物醫學工程學系 Department of BioMedical Engineering
論文出版年：	2016
畢業學年度：	104
語文別：	英文
論文頁數：	71
中文關鍵詞：	評估、吞嚥障礙、虛擬實境、電刺激、吞嚥治療
外文關鍵詞：	Evaluation, Deglutition disorders, Virtual reality, Electrical stimulation, Swallow therapy
相關次數：	點閱：120 下載：0
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吞嚥障礙，可由許多不同的疾病造成，會增加肺炎、脫水與營養不良的問題。本研究的目的是發展一套新的評估與治療系統，藉著電刺激與虛擬實境生物回饋，來輔助吞嚥治療。測得下頷肌群的活動和喉頭移動的加速情況，當作評估與生物回饋輔助治療的資訊。本研究試驗的方式包含可行性評估的概念性試驗 (proof of concept study) 與效能驗證的病例對照試驗（case control study）研究法。
在概念性試驗研究中，為試驗虛擬實境生物回饋治療效果，21位中風後慢性吞嚥障礙患者，吞嚥障礙超過6個月（26.3 ± 28.6個月）接受每週3次，每次1小時共16次的吞嚥治療，包括30分鐘傳統吞嚥治療及30分鐘虛擬實境治療。治療後，其功能性由口進食量表（Functional Oral Intake Scale, FOIS）分數由3.3 ± 1.5進步至5.0 ± 1.6，具統計顯著差異 (p = 0.00)。為測試電刺激之功效，分別以無吞嚥礙之正常人13位，每次吞嚥，在測得舌下肌動作後，給予電刺激至喉頭上升後2 秒鐘、10次，取平均值。研究結果顯示，有無電刺激的吞嚥反射時間各為456.17 ± 106.92 ms與552.13 ± 105.97 ms，具統計顯著差異（p = 0.04）；喉頭提升加速度值各為0.23 ± 0.1 g (g = 9.8 m/s2) 與0.20 ± 0.08 g，具統計顯著差異(p = 0.03)。
在病例對照試驗研究中，探討虛擬實境（遊戲式）生物回饋治療效果。受試者為中風後致吞嚥障礙者。患者20名，經年齡、性別、中風持續期間與吞嚥嚴重度配對，分為實驗組位及控制組各10名。所有受試者均接受每週3次，每次1小時共16次的吞嚥治療，包括30分鐘傳統吞嚥治療及30分鐘喉上抬運動。其中實驗組的病人，在喉上抬運動訓練中輔以虛擬實境生物回饋。受試者的吞嚥功能評估為舌骨位移距離與FOIS分數。研究結果顯示僅實驗組的舌骨位移距離與FOIS分數差異達統計上的顯著進步（p值各為0.002與0.004）；其 FOIS值由1.90 ±0.88進步至5.10 ± 1.20, 舌骨位移距離由11.37 ± 2.31 mm進步至14.45 ± 2.60 mm。且這兩項功能指標進步的差異，均達組間顯著差異（p值各為0.014與0.007）。治療後，鼻胃管的移除，實驗組10位病患，有8位 (80%)，而控制組10位病患，有2位 (20 %)；實驗組具較高的移除率(OR = 6.00; 95% CI, 1.08–33.27, p = 0.009).。
結果顯示，本研究之新式吞嚥障礙評估與治療儀（虛擬實境回饋與同步電刺激），對吞嚥障礙之治療，具有進一步臨床試驗之可行性。對中風後致吞嚥障礙者，虛擬實境生物回饋治療可增加舌骨位移距離、FOIS分數與鼻胃管移除率。

Dysphagia, which results from various disorders, may increase the risk of aspiration pneumonia, dehydration, and malnutrition. The aim of this study was to develop an innovative evaluation and treatment system for swallowing therapy using electrical stimulation (ES) and virtual reality (VR) feedback. In this system, the activation of the submental muscle and acceleration of laryngeal movement are used as the evaluation and feedback information. This study was composed of a proof of concept study for the initial feasibility evaluation and a case control study for function verification.
In the proof of concept study, twenty-one patients with chronic dysphagia post stroke over 6 months (26.3 ± 28.6 months) were recruited for the VR feedback study. Each participant underwent 1-hour sessions three times a week for a total of 16 treatment sessions. Each session included a 30-minute session of traditional swallow treatment and a 30-minute session of VR feedback therapy. After therapy, the Functional Oral Intake Scale results changed from 3.3 ± 1.5 to 5.0 ± 1.6 with statistical significance (p = 0.00). Besides, thirteen healthy subjects were enrolled in the ES study. ES was applied while submental muscles activated and continued for 2 seconds after laryngeal movement occurred for 10 times. With and without ES, swallowing triggering times were 456.17 ± 106.92 and 552.13 ± 105.97 ms, respectively. These differences were statistically significant (p = 0.04). Accelerations of laryngeal movement were 0.23 ± 0.1 g (g = 9.8 m/s2) and 0.20 ± 0.08 g respectively, with a significant statistical difference (p = 0.03).
To evaluate the functional value of VR (game-based) biofeedback in swallowing therapy for patients with post-stroke dysphagia, we conducted the followed case control study. 20 subjects with post-stroke dysphagia were individually and equally matched to two separate groups, VR (game-based) biofeedback or control, for age, sex, duration of dysphagia and dysphagia grades. Each participant underwent 1-hour sessions three times a week for a total of 16 treatment sessions. Each session included a 30-minute session of traditional swallow treatment and a 30-minute session of laryngeal elevation exercises. In the experimental group, laryngeal elevation exercises were combined with additional game-based biofeedback. After therapy, intragroup analyses showed that the hyoid bone displacement change and FOIS scores before and after treatment, showed statistically significant improvement only in the experimental group (p=0.002 and 0.004, respectively). The FOIS results changed from 1.90 ± 0.88 to 5.10 ± 1.20 and the hyoid bone displacement changed from 11.37 ± 2.31 mm to 14.45 ± 2.60 mm. Intergroup analyses showed larger differences in hyoid bone displacement and FOIS scores (before and after treatment) in the experimental group than in the control group, with statistical significance (p= 0.007 and p= 0.014, respectively). Eight (80%) of 10 patients in the experimental group and 2 (20%) of 10 control patients discontinued nasogastric tube insertion after therapy. Participation in the experimental group was associated with an increased probability of tube removal (OR = 6.00; 95% CI, 1.08–33.27, p = 0.009).
The feasibility of a prototype that combines swallowing evaluation, VR feedback therapy, and synchronized ES is demonstrated for further clinical trials. Laryngeal elevation training combined with VR biofeedback augments the change in hyoid bone displacement, FOIS scores, and increases NG tube removal rate in patients with post-stroke dysphagia.

 Contents
Chapter 1 Introduction	1
1.1 Background	1
1.2 Swallowing Physiology	1
1.3 Post Stroke Dysphagia	4
1.4 Evaluation of Swallowing	5
1.5 Treatment for Dysphasia	7
1.5.1 Exercise	7
1.5.2 The effortful swallow and the Mendelsohn maneuver	8
1.5.3 Biofeedback	8
1.5.4 Electrical Stimulation	13
1.6 The aims of this study	14
Chapter 2 Materials and Methods	16
2.1 Subjects	16
2.1.1 VR feedback treatment on chronic dysphagia patients: a proof of concept study	16
2.1.2 sEMG-triggered ES on healthy subjects: a proof of concept study	16
2.1.3 Swallowing training combined with game-based biofeedback in post-stroke dysphagia: a case control study	16
2.2 System design	21
2.2.1 Swallowing evaluation system	21
2.2.2 Calibration and placement of accelerometer	23
2.2.3 Onset Time Determination of sEMG	26
2.2.4 VR-based biofeedback system	29
2.2.5 Synchronization between swallowing and ES	30
2.3 Clinical outcome evaluation and statistical analysis	31
2.3.1 Triggering time and laryngeal movement acceleration	31
2.3.2 Functional Oral Intake Scale (FOIS)	32
2.3.3 Submental ultrasonography	33
2.3.4 Videofluorography	35
2.3.5 Statistical analyses	35
Chapter 3 Results	36
3.1 Swallowing evaluation and VR feedback treatment system	36
3.2 Clinical outcomes	41
3.2.1 VR feedback treatment on Chronic dysphagia in a proof of concept study	41
3.2.2 Electrical stimulation on healthy subjects in the proof of concept study	42
3.2.3 Swallowing Training Combined with Game-Based Biofeedback in Post-Stroke Dysphagia in a case control study	44
Chapter 4 Discussion and Conclusion	53
Conclusion and Future Work	60
References	62
 

Figure
Figure 1-1 Oral phase.	2
Figure 1-2 Pharyngeal phase.	3
Figure 1-3 Esophageal phase	4
Figure 1-4. Dual micro-switch method to measure swallow triggering time.	11
Figure 1-5 ES with various trigger mechanisms	14
Figure 2-1 The flow chart of this case control study.	21
Figure 2-2 The detection flow chart of the swallowing evaluation system.	23
Figure 2-3 Relationship between gravity and tilting with calibration.	24
Figure 2-4 Calibration of the 3-axis accelerometer under six-position method.	25
Figure 2-5 The positions and corresponding accelerating direction of the tri-axis accelerometer………………………………………………………………………………...26
Figure 2-6 Electrode positions relative to hyoid bone and thyroid cartilage.	27
Figure 2-7 Off-line sEMG Analysis.	28
Figure 2-8 Real-time sEMG Analysis.	29
Figure 2-9 Illustration of the VR biofeedback system for dysphagia patient.	30
Figure 2-10 Frequency response of band-reject comb filter.	31
Figure 2-11 Hyoid bone displacement in ultrasonography.	34
Figure 3-1 Detection of voluntary submental muscles activation..	36
Figure 3-2 Acceleration signal and sEMG recorded for determining triggering time..	37
Figure 3-3 VR system and real-time analysis system communicate via TCP/IP protocol.	38
Figure 3-4 Three swallowing wave activities.	39
Figure 3-5 Frog ready to open its mouth with activated submental muscle of participant (1)..	40
Figure 3-6 Frog ready to open its mouth with activated submental muscle of participant (2)..	41
Figure 3-7 FOIS score before and after treatment with VR feedback.	42
Figure 3-8 Triggering time and acceleration of laryngeal elevation.	43
Figure 3-9 VF for a patient, pretreatment..	49
Figure 3-10 VF for a patient, post treatment.	50
Figure 3-11 Ultrasonographic evaluation for a patient, pretreatment..	51
Figure 3-12 Ultrasonographic evaluation for a patient, posttreatment	52
 

Table
Table 1-1 Dysphagia measurement with tools and/or for feedback therapy	11
Table 2-1 The characteristics of the experimental group	18
Table 2-2 The characteristics of the control group	19
Table 2-3 Comparisons of 2 groups in demographics and characteristics of the patients	20
Table 2-4 Functional Oral Intake Scale (FOIS)	32
Table 3-1 The characteristics of FOIS score and hyoid displacement in the experimental group	44
Table 3-2 The characteristics of FOIS score and hyoid displacement in the control group	45
Table 3-3 Hyoid Bone Displacement Change (before and after therapy)	46
Table 3-4 FOIS Score Change Before and After Therapy	47
Table 3-5 NG tube insertion	48


                                    

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