Design of a Low-Cost Therapeutic Device for Patients With Radiation-Related Trismus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Mean change in maximum interincisal opening (MIO) over time
研究概览
简要总结
This trial evaluates how well a new therapeutic device works in managing trismus in patients who received radiation treatment for head and neck cancer. Radiation therapy is a common form of treatment in patients with head and neck cancers. However, changes to surrounding tissue following radiation therapy may lead to trismus, an inability to open the mouth fully. This can create significant functional impairment leading to malnutrition due to impaired chewing, risk of dental infections due to impaired oral hygiene, difficulty with speech, and decreased health-related quality of life. Exercise therapy is the mainstay of treatment for post-radiation trismus to help improve mobility and flexibility and increase range of mouth opening. This new device is non-invasive and is similar to other jaw stretching devices where a mouthpiece is placed between the teeth and a hand-lever is used to spread open the upper and lower jaw. However, it will also have additional sensors to measure pressure exerted by the hands and jaw as well as the distance to open the mouth which could help guide therapy. This study may help doctors customize a device to patient-specific needs, provide real-time feedback, and encourage compliance for trismus exercise therapy.
详细描述
PRIMARY OBJECTIVE:
I. To assess the clinical efficacy of the trismus device, as measured by the change in maximum interincisal opening over the six-week treatment period.
SECONDARY OBJECTIVE:
I. To assess participants compliance rates and jaw opening pressures when using this device.
OUTLINE: Participants are assigned to 1 of 2 parts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female >= 18 years of age at visit
- •Documentation of a radiation-induced trismus diagnosis as evidenced by one or more clinical features consistent with the trismus phenotype (maximum interincisal opening (MIO) < 35 mm) and a history of head and neck radiation
- •Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
排除标准
- •Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.
- •Minors (age < 18 years) or patients with inability to provide informed consent.
研究组 & 干预措施
Part I (medical device usage, questionnaire)
Each participant will complete a single 45-minute visit in which consists of questionnaires about features that are important to them in trismus treatment, test a prototype of a trismus therapy device, and complete an online feedback questionnaire about their experience using the device.
干预措施: Trismus Device Prototype (Device)
Part I (medical device usage, questionnaire)
Each participant will complete a single 45-minute visit in which consists of questionnaires about features that are important to them in trismus treatment, test a prototype of a trismus therapy device, and complete an online feedback questionnaire about their experience using the device.
干预措施: Questionnaires (Other)
Part II (medical device usage, mobile app usage)
Participants will be asked to use the device at least three times per week and up to daily for a period of 15-20 minutes over 6 weeks. Participants will be evaluated at baseline, at the 3-week (halfway) visit, and at the end of the 6-week treatment period under supervision of a speech language pathologist on study. Participants will then utilize a mobile app to help track treatment progress.
干预措施: Trismus Device Prototype (Device)
Part II (medical device usage, mobile app usage)
Participants will be asked to use the device at least three times per week and up to daily for a period of 15-20 minutes over 6 weeks. Participants will be evaluated at baseline, at the 3-week (halfway) visit, and at the end of the 6-week treatment period under supervision of a speech language pathologist on study. Participants will then utilize a mobile app to help track treatment progress.
干预措施: Mobile Application (Other)
结局指标
主要结局
Mean change in maximum interincisal opening (MIO) over time
时间窗: Up to 6 weeks
The mean change in MIO from baseline to end of treatment at 6 weeks will be reported
次要结局
- Rate of compliance(Up to 1 year)
- Number of participants with device-related adverse events(Up to 1 year)