Please select the outcome measures that correspond to the clinical trial below.
Title: The Effect of the Transcranial Direct Current Stimulation Combined Sensory Modulation Intervention on Upper Extremity Functional Rehabilitation in Patients With Chronic Stroke
Brief Summary: Background and purpose:

About 30% of people with stroke suffered from severe long-term upper extremity （UE） motor impairment. Severe UE impairment, especially dysfunction of hand, can greatly impact stroke patients' daily living independence and quality of life. However, treatment effect of current interventions is still limited. Nick Ward and Leonardo Cohen suggested 5 intervention strategies for stroke motor recovery: （1） reduction of somatosensory input from the intact; （2） increase in somatosensory input from the paretic; （3） anesthesia of a body part proximal to the paretic hand; （4） activity within the affected motor cortex may be up-regulated; （5） activity within the intact motor cortex may be down-regulated. Recent studies have shown each strategy to be effective in stroke patients with mild or moderate UE impairment. However, evidence for people with severe UE impairment after stroke remains unclear. Since research has found a greater effect for combined strategies than a single strategy, this proposal develops a combined intervention with the above 5 strategies, named "transcranial direct current stimulation （tDCS） combined sensory modulation intervention". This intervention is expected to be most effective for people with severe UE impairment after stroke.

In addition, neuroimaging can provide in vivo information about the brain plasticity which underpinning the motor recovery after stroke. However, image indexes that can be used in stroke patients with severe UE impairment remained examined. Therefore, this proposal has 3 aims: （1） to examine the treatment effect of the "tDCS combined sensory modulation intervention" in stroke patients with severe UE impairment; （2） to examine the underline mechanism of the efficacy of "tDCS combined sensory modulation intervention" using neuroimaging technology.

Methods:

This study is a double-blinded randomized controlled trial which will recruit 60 people who have had stroke onset more than 6 months and have severe UE motor impairment. All participants will be randomly assigned into 2 groups. The experimental group will be given the "tDCS combined sensory modulation intervention", combining bilateral tDCS stimulation, anesthesia techniques and repetitive passive motor training. The control group is given sham tDCS, sham anesthesia and repetitive passive motor training. Each group will be evaluated for outcomes at 4 time points （i.e. baseline, post-intervention, 3 months and 6months post-intervention）. The immediate and long-term effect of the interventions will be examined.

Primary outcome indicators include upper extremity impairment measures. Secondary outcome measures include upper extremity function, activities of daily living function, functional Magnetic Resonance Imaging （fMRI）, and corticospinal tract structural integrity using diffusion spectrum imaging （DSI）. Fifteen subjects of each group will be assessed 2 times （i.e., prior to the intervention and after the intervention） for fMRI and DSI scan.

Anticipatory results and contributions:

The results of the studies are expected to present a potentially effective intervention for stroke patients with severe impaired UE motor. Imaging evidence of brain plasticity for this particular intervention is also provided. The results will contribute to our understanding of brain plasticity for UE motor recovery after stroke. Findings from this proposal may help researchers and clinicians choose or develop interventions that are optimal to their clients individually.


Options:
A: Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection) (6 weeks)
B: change in function before/after tDCS (Before intervention, immediately after intervention, 10-20-30-40-50-60 min after intervention; long-term after intervention : 1-2-3-4 weeks, 2-3-4-5-6-7-8-9-10-11-12 months)
C: Change in active control zone of the elbow (2 weeks and 1 month)
D: Change from baseline Fugl Meyer Assessment(FMA)upper extremities subscale after intervention (Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)); Change from baseline Active joint activity after intervention (Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section)); Change from baseline Muscle tone after intervention (Assessed at the baseline section (within 3 days ahead to the 1st intervention section), and then again immediately following the 8 weeks intervention (within 3 days after the latest intervention section))

Answer: D