Effects of Limb Cooling on Essential Tremor.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Hand writing assessment battery on limb cooling at 60 minutes post-cooling
研究概览
简要总结
Essential Tremor (ET) is characterized by tremors affecting the arms. The investigators will examine the effects of non-pharmacological limb cooling on clinical and physiological characteristics in patients presenting with ET at three different temperatures; and will measure changes in tremor amplitude after cooling of the upper limb.
详细描述
Once the subject has agreed to participate in the study the following assessments will be performed.
Three non-pharmacological assessments will be performed at different temperature to the upper limbs. The first will be a baseline assessment with upper limbs maintaining a normal body temperature (96-98°F). The second assessment will be performed with upper limbs at a temperature of 59°F and the third will be performed at a temperature of 80°F for a period of 10 minutes. At the end of 10 minutes, tremor measurements will be 15, 40, and 60 minutes.
- Assessments will include the Tremor Rating Scale (TRS), Handwriting Assessment Battery (HAB) and the Functional Dexterity Test (FDT).
- The Bagnoli and Trigno EMG systems will record surface EMG signals from muscles and accelerometer readings.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range 18 to 95 years,
- •Clinical diagnosis of essential tremor for at least a year,
- •A +2 or worse action or kinetic tremor of one or both upper limbs involving at least the forearm and/or hand
排除标准
- •Dermatologic lesions in upper limbs (e.g. skin cancer, eczema, fresh or healing wounds, abrasions, acne, pustules, abscesses, or skin rash),
- •Sensory loss in the upper limbs,
- •Known history of sensitivity to cold (i.e., cold urticaria),
- •Known peripheral vascular disease,
- •Raynaud's phenomenon,
- •Scleroderma
- •Healthy normal controls will be enrolled through advertisements. All controls will be examined to ensure that they are neurologically healthy.
- •The exclusion criteria for controls will remain same as those for patient subjects.
结局指标
主要结局
Hand writing assessment battery on limb cooling at 60 minutes post-cooling
时间窗: 60 minutes post-cooling.
Handwriting assessment battery includes pen control and manipulation subtests showed high to perfect agreement (line drawing subtest, κ = 1.0; dot subtest, κ = 0.80). The speed subtest showed perfect agreement (ICC = 1.0). Writing legibility showed high agreement for all five subtests (ICC = 0.71-0.83).
Hand writing assessment battery on limb cooling at 15 minutes post-cooling
时间窗: 15 minutes post-cooling.
Handwriting assessment battery includes pen control and manipulation subtests showed high to perfect agreement (line drawing subtest, κ = 1.0; dot subtest, κ = 0.80). The speed subtest showed perfect agreement (ICC = 1.0). Writing legibility showed high agreement for all five subtests (ICC = 0.71-0.83).
Tremor rating scale on limb cooling at 40 minutes post-cooling
时间窗: 40 minutes post-cooling.
Tremor Rating Scale (TRS), consists of 11 items that evaluate tremor in the head, arms, and legs. The rater assigns a score of 0 to 4 for each item, in ascending order of severity.
Functional dexterity test on limb cooling at 60 minutes post-cooling
时间窗: 60 minutes post-cooling.
Functional Dexterity Test (FDT) two scores are obtained: (1) time, in seconds, to complete the test and (2) combined total time with penalty seconds added to the initial time. If the patient exceeds 55 seconds, he or she receives a non-functional rating.
Functional dexterity test on limb cooling at 40 minutes post-cooling
时间窗: 40 minutes post-cooling.
Functional Dexterity Test (FDT) two scores are obtained: (1) time, in seconds, to complete the test and (2) combined total time with penalty seconds added to the initial time. If the patient exceeds 55 seconds, he or she receives a non-functional rating.
Hand writing assessment battery on limb cooling at 40 minutes post-cooling
时间窗: 40 minutes post-cooling.
Handwriting assessment battery includes pen control and manipulation subtests showed high to perfect agreement (line drawing subtest, κ = 1.0; dot subtest, κ = 0.80). The speed subtest showed perfect agreement (ICC = 1.0). Writing legibility showed high agreement for all five subtests (ICC = 0.71-0.83).
Tremor rating scale on limb cooling at 15 minutes post-cooling
时间窗: 15 minutes post-cooling.
Tremor Rating Scale (TRS), consists of 11 items that evaluate tremor in the head, arms, and legs. The rater assigns a score of 0 to 4 for each item, in ascending order of severity.
Functional dexterity test on limb cooling at 15 minutes post-cooling
时间窗: 15 minutes post-cooling.
Functional Dexterity Test (FDT) two scores are obtained: (1) time, in seconds, to complete the test and (2) combined total time with penalty seconds added to the initial time. If the patient exceeds 55 seconds, he or she receives a non-functional rating.
Tremor rating scale on limb cooling at 60 minutes post-cooling
时间窗: 60 minutes post-cooling.
Tremor Rating Scale (TRS), consists of 11 items that evaluate tremor in the head, arms, and legs. The rater assigns a score of 0 to 4 for each item, in ascending order of severity.
次要结局
- Effect of limb cooling on the physiological characteristics of essential tremors.(15 minutes post-cooling.)