This study aims to analyze the use of non-invasive brain stimulation (tDCS) is beneficial for the treatment of post-stroke fatigue.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
Non invasive brain stimulation with sham and active comparators
Hospital Clínic de Barcelona
Barcelona, Spain, Spain
RECRUITINGFatigue Assessment Scale
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.
Time frame: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.
HADS
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.
Time frame: 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
It is a scale with 15 items that is used to measure the severity of stroke. It includes different areas: level of consciousness, eye movements, integrity of visual fields, facial movements, muscle strength, sensitivity, coordination, language and negligence. Each item is scored on an ordinal scale from 0 to 2, 0 to 3 or 0 to 4. The total is added and a score is obtained that can range from 0 to 42, the higher the score, the greater the deficits.
Time frame: Baseline. Reported through study completion, an average of 1 year.
Borg Modified Scale
The Borg scale is a tool that measures a person's perception of exertion, shortness of breath, and fatigue during physical exertion. It is a modified scale, it is an 11-point scale that ranges from 0=no fatigue to 10=very great effort.
Time frame: During the sessions. Reported through study completion, an average of 1 year.
PROMIS-Sleep
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This is a Likert-type scale that evaluates the quality of sleep during the last week. Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Time frame: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.
Modified Rankin Scale
It is the most commonly used functional measure in stroke research, particularly in studies evaluating the effectiveness of treatments. The scale is numerical and ranges from 0 to 6. 0: no symptoms; 1: without significant disability (the patient is able to carry out his/her usual activities and obligations); 2: mild disability; 3: moderate disability; 4: moderately severe disability; 5: severe disability (totally dependent patient); 6: death.
Time frame: Baseline, 1 month post intervention and 6 months post intervention. Reported through study completion, an average of 1 year.
International Physical Activity Questionnaire (IPAQ)
To measure the level of physical activity during the last week. There are two forms of output from scoring the IPAQ. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity. A MET is a multiple of your estimated resting energy expenditure. One MET is what you expend when you are at rest. Therefore 2 METS is twice what you expend at rest. To get a continuous variable score from the IPAQ (MET minutes a week) we will consider walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS.
Time frame: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.
Eq-5D
Assess the quality of life perceived by the patients. The scale ranges from 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine'). This is used to obtain a respondent's stated preference values, not to record their own health state.
Time frame: Baseline, 1 month post intervention and 3 months post intervention. Reported through study completion, an average of 1 year.