Rehabilitation of Head and Neck Cancer Patients With Biofeedback Training to Improve Speaking and Eating in Public
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in Percent Intelligibility of Speech Over 4 Months
研究概览
简要总结
Tongue cancer requires resection and reconstruction that can leave patients disabled with respect to speaking and eating. Impairment of tongue function can have significant impact on social interaction and employment. To try and improve speaking and eating in public, the team at the University Health Network is going to use a special device that is designed to help the patient rehabilitate after tongue cancer treatment.
The research part of this study is to use a special mouthpiece or mold that is like a partial plate for upper dentures that will fit on the roof of the mouth. This mold is embedded with 62 sensors that will allow patients to visualize their tongue position during speech. With the help of a speech therapist, patients can learn different tongue positions important speaking and eating. This whole process is called biofeedback. The visualization of the tongue gives the patient the flexibility to practice at home to and learn different tongue positions important to eating and speaking. In addition, the device will provide the speech pathologist with an opportunity for easier and more precise assessment of the patient's progress which can reduce the need for visits to the hospital. The investigators expect the biofeedback training to improve the patient's speaking and eating.
The study hypothesis is that the biofeedback device will improve speech intelligibility, eating in public, speaking in public, and oral intake scores.
详细描述
Subjects will be enrolled in either arm of the study for duration of 4 months. Patients that are randomized into study arm 1 will come to the clinic for Speech Language Pathologist (SLP) directed face-to-face rehabilitation for a period of 2 months. The patients will then transition to participate in weekly face-to-face Electropalatography (EPG) biofeedback training. The EPG biofeedback will be used for 2 months. Patients that are randomized into study arm 2 will first undergo a self-directed tongue strengthening program (oral exercises) for a period of 2 months and then transition into EPG biofeedback training.
Although randomization will be used, this is a nonstandard trial because all patients will receive biofeedback EPG. Patients from both study arms will receive biofeedback training after undergoing an SLP directed face-to-face rehabilitation program versus a self-directed tongue strengthening program (oral exercises). The SLP directed face-to-face rehabilitation program or self-directed tongue strengthening program will be initiated at least 2 weeks post-surgery. If the patient is treated with adjuvant radiation, the patient will take a self-directed biofeedback holiday with a target of restarting at least 2 after the completion of adjuvant treatment.
This design was chosen because there is equipoise with respect to the efficacy of the intervention and uncertainty with respect to whether the intervention is most valuable following an SLP directed face-to-face rehabilitation program versus a self-directed tongue strengthening program. The design offers all patients the opportunity to participate in the intervention. This approach will also allow us to analyze between subject change and within subject change.
The A.I.D.S assessment has been in place for approximately 50 years. The mean A.I.D.S. efficiency score (95%CI) in the current pilot study (n=16) is 0.54 (46.0, 62.3). With 33 patients in each group, there will be over 80% power to detect a 10% difference in the speech efficiency score even under the condition that there may be low (rho<0.1) correlation within subject. Higher correlation within subject on the various scores would serve to increase the efficiency of the analysis.
Bivariate comparison will be made between the arms with respect to the primary and secondary outcome variables at each time point.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Oral cavity carcinoma involving the tongue or floor of the mouth
- •Primary surgical treatment or/
- •Primary surgical treatment with adjuvant radiation therapy or/
- •Salvage surgical treatment
- •At least 2 weeks post treatment
排除标准
- •Anatomic palate abnormality that precludes fitting a mouthpiece
- •Cognitively unable to participate in biofeedback
- •Persistent Cancer
- •Does not speak English
研究组 & 干预措施
Self-Directed Tongue Strengthening Rehab
8 sessions of self-directed tongue strengthening exercises followed by 8 sessions of electropalatography biofeedback training.
Assessments will be taken during the beginning, middle, and end of each study arm.
干预措施: Electropalatography Biofeedback Training (Device)
SLP Directed Face-to-Face Rehab
8 sessions of SLP-directed face-to-face rehabilitation program followed by 8 sessions of electropalatography biofeedback training.
Assessments will be taken during the beginning, middle, and end of each study arm.
干预措施: Electropalatography Biofeedback Training (Device)
结局指标
主要结局
Change in Percent Intelligibility of Speech Over 4 Months
时间窗: Administered at 0, 2, and 4 months
Change in percent intelligibility is measured using Assessment of Intelligibility of Dysarthric Speech (AIDS). Assessment of Intelligibility of Dysarthric Speech (AIDS) is a validated tool that is used in this outcome to measure intelligibility as compared with normal subjects for quantifying single-word intelligibility and sentence intelligibility.
Change in Rate of Intelligible Speech Over 4 Months
时间窗: Administered at 0, 2, and 4 months
Change in intelligibility rate is also measured using Assessment of Intelligibility of Dysarthric Speech (AIDS). Assessment of Intelligibility of Dysarthric Speech (AIDS) is a validated tool that is used in this outcome to measure speed of language as compared with normal subjects for quantifying speaking rate.
Change in Speech Acceptability Over 4 Months
时间窗: Administered at 0, 2, and 4 months
Assessment of Speech Acceptability is a qualitative measure of "conversational understandability" of language as compared with normal subjects. Subjects will be given 6-word sentences to read where five naïve listeners will evaluate the speakers' speech acceptability on a scale of 4. This is a subsection of the AIDS test.
Change in Speech and Swallowing Over 4 Months
时间窗: Administered at 0, 2, and 4 months
This is a disease specific, 6-item, administered questionnaire to evaluate post-treatment speech and swallowing ability measure will provide critical data on the socialization of the patient as it relates to speaking and eating.
次要结局
- Difference in Cost for Intervention versus Standard of Care Over Time(Weekly, Up to 16 Weeks)
- Change in Patient Satisfaction of EPG Biofeedback Over 4 Months(Administered time 0, 2, and 4 months)