Feasibility and Effectiveness of Tdcs in a Multimodal Treatment With Health Education and Aerobic Exercise in the Treatment of Post-stroke Fatigue.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Fatigue Assessment Scale
研究概览
简要总结
This study aims to analyze the use of non-invasive brain stimulation (tDCS) is beneficial for the treatment of post-stroke fatigue.
详细描述
A single-blind randomized clinical trial will be conducted. The intervention will consist of 8 20-minute tDCS sessions conducted over four weeks. The stimulation will be performed by applying the stimulation to the dorsolateral prefrontal cortex on the left side (F3) and the cathode will be at point O2 of the right hemisphere. The study will consist of two groups: the control group in which sham stimulation will be applied and therapeutic education and aerobic exercise; the intervention group in which stimulation, therapeutic education and therapeutic exercise will be carried out.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First stroke within 45 (+-7) days of the ischemic or hemorrhagic episode.
- •Ability to understand and execute simple instructions
- •Over 18 years.
- •Fatigue Scale of fatigue severity with a score greater than or equal to 24
排除标准
- •A score > 2 on the modified Rankin Scale (mRS) before the stroke.
- •Patients with decompensated cardiorespiratory and/or psychiatric pathology.
- •Comorbidity causing disproportionate fatigue, such as long-term COVID.
- •Patients who are cancer survivors or who are undergoing cancer treatment.
- •Patients with a history of epilepsy or who are taking antiepileptic medication.
- •Patents with major depression.
研究组 & 干预措施
Control group
- Therapeutic education about post-stroke fatigue
- Sham stimulation with tDCS: Anode placed in F3 and cathode in O2, 20 minutes.
- Aerobic exercise measured with Borg scale (moderate intensity)
干预措施: tDCS (Device)
Experimental group
- Therapeutic education about post-stroke fatigue
- Stimulation with tDCS: Anode placed in F3 and cathode in O2, intensity 2mA during 20 minutes.
- Aerobic exercise measured with Borg scale (moderate intensity)
干预措施: tDCS (Device)
结局指标
主要结局
Fatigue Assessment Scale
时间窗: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.
The scale consists of 10 questions about the characteristics of fatigue in the current daily routine, which are rated on a five-point range from 1, "never," to 5, "always." Higher scores indicate more fatigue, with a cut-off point of ≥24 defining the presence of fatigue.
HADS
时间窗: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.
It is a scale that can be used both at the hospital and outpatient level. It consists of 14 questions: 7 questions related to depression and another 7 related to anxiety. An independent score on each scale of ≥ 8 will be suggestive of depression and/or anxiety.
次要结局
- Borg Modified Scale(During the sessions. Reported through study completion, an average of 1 year.)
- PROMIS-Sleep(Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.)
- International Physical Activity Questionnaire (IPAQ)(Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.)
- National Institute of Health Stroke Scale(Baseline. Reported through study completion, an average of 1 year.)
- Modified Rankin Scale(Baseline, 1 month post intervention and 6 months post intervention. Reported through study completion, an average of 1 year.)
- Eq-5D(Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.)
研究者
Inés García Bouyssou
Physical therapist
Hospital Clinic of Barcelona