Pilot Clinical Trial to Study Facial Electrical Stimulation to Promote Recovery in Patients With Bell's Palsy and Poor Prognostic Factors
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Recovery at 3 Months as Measured From Facial Photos With Different Facial Expressions
研究概览
简要总结
A feasibility pilot study to exam the necessary methodology for conducting a larger clinical trial for Bell's Palsy patients with a poor prognosis and the use of electrical stimulation.
详细描述
Here we describe a protocol for a prospective, randomized, double-blinded study to evaluate the effects of monophasic pulsed current ES on patients with Bell's palsy and factors predicting poor recovery, with a 6 month follow up. Motor level stimulation with a pulse duration of 100 μsec and a frequency of 35 pulses per second were chosen from focus group with physical therapist to treat facial paralysis and are consistent with clinical trials showing motor benefit after capel tunnel surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Investigator and outcome assessors are blinded to the intervention. The physical therapist that teaches the research subjects how to perform the interventions are not blinded and patients are told they are assigned to either sensory or subsensory protocols.
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
- •New diagnosis of bell's palsy (diagnosed in the last 30 days)
- •IF younger than 60 years of age must have complete paralysis on one side of face or both
- •IF older than 60 years of age paralysis must be present but CAN be incomplete.
排除标准
- •Paralysis associated with any of the fallowing: cancer, tumor, surgery, stroke, or trauma.
- •Younger than 60 years old with INCOMPLETE paralysis.
- •Non English speakers
- •Pacemaker or deep brain stimulator
结局指标
主要结局
Recovery at 3 Months as Measured From Facial Photos With Different Facial Expressions
时间窗: 3 months
To evaluate for complete recovery, standardized photos of patients at rest, and during movement, will be evaluated by three treatment-blinded otolaryngologists. Total number of patients fully recovered over number of participants will be reported.
次要结局
- Eye Closure(Baseline and 3 months)
- Smile Excursion(Baseline and 3 months)
- Patient Reported Global Quality of Life Specific to Facial Paralysis(Baseline, 3 months and 6 months)
- Self Reported Subject Adherence(3 months)
- House Brackmann Scale(Baseline, and 3 months)
- Patient Reported Quality of Life in Relation to Facial Synkinesis Measured by the Synkinesis Assessment Questionnaire (SAQ)(Baseline, 3 months and 6 months)
- Objective Measurements of Brow Elevation(Baseline and in 3 months)
- Facial Symmetry During Smile(Baseline and 3 months)
- Facial Symmetry at Rest(Baseline and 3 months)
- Patient Tolerability(3 months)
研究者
Myriam Loyo
Assistant Professor
Oregon Health and Science University