Stimulate One Hand to Improve Tactile Perception on the Other
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Tactile acuity : composite of 2point discrimination test (2PDT) and Absolute threshold detection test after 45minutes of RSS
研究概览
简要总结
The study is a comparative study, to show that the administration of RSS stimulation on one hand compared to the administration of strategy Sham stimulation, results in an temporary improvement in the tactile acuity of the other hand in patients with tactile acuity impairment of the hand due to stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
Experimenter 2 will be in charge of the randomization. He will establish a randomization list through Excel and assign to each patient one of the two possible order (Day 1 RSS / Day 2 Sham OR Day 1 Sham / Day 2 RSS). This Excel will be protected through a password and kept in the CRNL server. He will then fill the envelopes with the order assigned by the randomization list and seal them. Each envelope is assigned an inclusion number.
On the inclusion visit (J0), once the consent form is signed, the sealed envelope will be kept in the medical file of the patient. On the first visit (J1). Experimenter 1 will assess the performance of the patient through the tactile and motor tests, while the Exp2 will be in charge of applying the stimulation.
Once Exp1 finished doing the tactile and motor tasks, she will leave the room and Exp2 will enter in the room, open the sealed envelope and apply the stimulation. He will stay in the room with the patient during the stimulation duration.
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 30-80 years old
- •Patients with diagnosis of unilateral (both right and left) ischemic or hemorrhagic stroke
- •Stroke event dates at least 3 months before the date of inclusion to the study
- •Severe-to-mild sensory loss at the fingers of the hand contralateral to the stroke lesion (affected hand)
- •Capacity to provide written consent
- •Affiliation to a social security scheme
- •Non inclusion Criteria * :
- •Sensory impairment attributable to diabetes history, peripheral vascular disease or neuropathy
- •Severe speech disorder, global aphasia and/or cognitive impairment
- •Multiple stroke events
- •Bilateral stroke event
- •History of neurological or psychiatric illness
- •Other experimental procedure is forbidden during the weeks where the study is performed
- •Pregnant, parturient and lactating women
- •Persons deprived of their liberty
- •Adult persons subject to a legal protection measure: guardianship, curatorship
- •Persons in psychiatric care
- •Congenital or acquired malformation/injury of the test fingers
- •Impossibility to maintain hand position necessary for the tests due to severe spasticity
排除标准
- •Severe impairment of the sensibility of the index finger of the spared hand preventing the administration of the RSS
结局指标
主要结局
Tactile acuity : composite of 2point discrimination test (2PDT) and Absolute threshold detection test after 45minutes of RSS
时间窗: Immediate after the 45 minutes of RSS
To show that RSS applied for 45 minutes on the index finger of the spared hand in stroke patients suffering from sensory deficits improves their tactile sensitivity on the affected (unstimulated) hand, measured in terms of improved spatial discrimination and/or improved absolute detection.
次要结局
- Jebsen-Taylor hand function test (JTHFT)(Immediate after the 45 minutes of RSS)
- Manual dexterity Pegboard test(Immediate after the 45 minutes of RSS)