The Use of Sensory or Motor Cues Using Electrical Stimulation to Reduce Gait Freezing in Patients With Parkinson Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Timed Up and Go
研究概览
简要总结
Some individuals with Parkinson disease experience "freezing" during walking which results in their inability to move their feet. They often have difficulty starting to move once they have stopped. Freezing often results in loss of balance and falling. Oral medications for Parkinson disease aren't as effective in treating freezing as it is in reducing other symptoms. Another treatment for freezing is instruction in walking using visual targets or auditory cues (thinking of a rhythm or beat). These cues can be initially effective for some individuals, but the effects do not last. Other types of cues have not been studied. We want to examine the effects of two other cues, tactile (touch) or motor (muscle contraction), on the effects of freezing.
详细描述
We will use a device (TENS unit) that provides electrical stimulation to a nerve in the lower legs. Electrodes will be placed on the skin of your lower legs and a box that delivers electrical current will cause a tingling feeling in the legs. Subjects will be asked to perform three gait tasks with the device on and off to compare the effects of the sensory cue on the speed/time to complete gait tasks and the frequency and duration of any freezing events. This use of the device (TENS unit) is investigational. While it has been approved by the Food and Drug Administration for the treatment of pain, it has not been approved for the treatment of freezing. Because the TENS unit can provide a sensory cue, it may help to prevent or reduce freezing. If it is found that this cue works, it could lead to new treatments for the treatment of freezing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PD diagnostic criteria include those used for clinically defined "definite PD", as previously outlined22 based upon established criteria.22, 23
- •history of consistent freezing with ambulation in a straight line and/or when turning.
- •normal central and peripheral neurological function
- •at least grade 4 strength and normal joint ranges of motion in both legs
- •normal somatosensory function in the feet (joint position sense), except for their neurological diagnosis and use of levodopa.
- •Each must have had clear benefit from levodopa for at least some of his/her PD symptoms
- •All subjects with PD must be able to walk independently for 10 feet.
排除标准
- •serious medical problem that would impair the ability to undergo testing.
- •use of neuroleptic or other dopamine-blocking drug
- •use of drugs that might affect balance
- •history or evidence of other neurological deficit that could interfere, such as previous stroke or muscle disease
- •participants who are unable to provide informed consent
研究组 & 干预措施
Parkinson subjects with freezing
Each subject will have been diagnosed with Parkinson disease and will serve as his/her own control. Inclusion criteria: history of consistent freezing with ambulation in a straight line and/or when turning, normal central and peripheral neurological function, at least grade 4 strength and normal joint ranges of motion in both legs, normal somatosensory function in the feet (joint position sense), except for their neurological diagnosis and use of levodopa, each must have had clear benefit from levodopa for at least some of his/her PD symptoms, and all subjects with PD must be able to walk independently for 10 feet.
Exclusion criteria include: serious medical problem that would impair the ability to undergo testing, use of neuroleptic or other dopamine-blocking drug, use of drugs that might affect balance, history or evidence of other neurological deficit that could interfere, such as previous stroke or muscle disease, or participants who are unable to provide informed consent.
干预措施: Gait tests with and without the use of a tactile sensory cue (electrical stimulation using a TENS unit) (Device)
结局指标
主要结局
Timed Up and Go
时间窗: Time of study visit
次要结局
- Time to perform a 360 degree turn while standing in place(Time of study visit)
- Time to complete a figure-eight walking pattern around cones placed anterior and posterior to the subject(Time of study visit)