The specific study aims will be: 1. To investigate the short- and long-term treatment effects of action observation, imagery, and execution therapy (AOIE) compared with an action observation therapy (AO) group and a control treatment group as controls on different aspects of outcomes in patients with stroke. 2. To examine the neural mechanisms and changes in cortical neural activity after the interventions in stroke patients. 3. To examine the correlations between AOIE-induced brain activation changes and the clinical efficacy of AOIE. 4. To identify who are the possible good responders to the therapy based on baseline motor function and motor imagery ability of the participants.
The investigators propose a 3-year randomized controlled trial to (1) investigate the short- and long-term treatment efficacy of AOIE, action observation alone, versus control treatment on clinical outcomes of patients with subacute stroke, (2) examine the neural mechanisms and activation changes after the 3 interventions by using an advanced brain imaging technique, magnetoencephalography (MEG), (3) determine the correlations between neural activation changes and clinical outcomes, and (4) identify who are the good responders to the AOIE therapy. An estimated total of 96 patients with subacute stroke will be recruited in this study. All participants will be randomly assigned to receive 1 of the 3 interventions for 3 weeks (a total of 15 sessions). Clinical outcome measures will be conducted at baseline, immediately after treatment (3 weeks), and at 3 months follow-up. The MEG assessment will be conducted at baseline and immediately after treatment (3 weeks). For the MEG study, The investigators anticipate to enroll 12 to 15 patients in each group to complete neuroimaging evaluation because of the specific eligibility criteria and high costs of MEG. The patients can still participate in the study, receiving rehabilitation therapy and clinical evaluations, even if the participants will not be included in the MEG study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
17
The participants will be asked to observe movements through a video clip, practice motor imagery, and executing the movements that the participants observed.
The participants will be asked to observe videos and then practice what the participants observed.
The participants will receive UE training without watching videos or imagining movements/tasks.
Taipei medical university hospital
Taipei, Taiwan
Taipei Medical University Shuang Ho Hospital
Taipei, Taiwan
Taoyuan Chang Gung Memorial Hospital
Taoyuan, Taiwan
Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare
Taoyuan, Taiwan
Change scores of Modified Rankin Scale
The Modified Rankin Scale is used to assess the degree of stroke disability.
Time frame: baseline, 3 weeks , 3 months
Change scores of Fugl-Meyer Assessment
Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment.
Time frame: baseline, 3 weeks , 3 months
Change scores of Box and Block Test
The Box and Block Test is a measure of hand dexterity with satisfactory reliability and validity in patients with stroke.
Time frame: baseline, 3 weeks , 3 months
Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)
The CAHAI measures the upper-limb motor function after stroke.
Time frame: baseline, 3 weeks , 3 months
Change scores of Movement Imagery Questionnaire, revised second version
The MIQ-RS will be applied to assess patient's ability of motor imagery.
Time frame: baseline, 3 weeks , 3 months
Change scores of Functional Independence Measure
The Functional Independence Measure is a frequently used scale to assess basic activities of daily function.
Time frame: baseline, 3 weeks , 3 months
Change scores of physical intensity measured by activity monitors
The accelerometers (ActiGraph) are used to provide an objective measure of the amount of the affected arm in patient's real-life environments. The parameter of average intensity of physical activity (counts/minute) will be reported.
Time frame: baseline, 3 weeks , 3 months
Change scores of energy expenditure measured by activity monitors
The accelerometers (ActiGraph) are used to provide an objective measure of the amount of the affected arm in patient's real-life environments. The parameter of energy expenditure(Kcal) will be reported.
Time frame: baseline, 3 weeks , 3 months
Change scores of Stroke Impact Scale (SIS) Version 3.0
The Stroke Impact Scale Version 3.0 is a patient-reported outcome to evaluate function, participation, and health-related quality of life of stroke survivors with sound psychometric properties.
Time frame: baseline, 3 weeks , 3 months
Magnetoencephalography (MEG)
Magnetoencephalography (MEG) can directly measure cortical neural activity and detect the oscillatory signals mainly by the changes in the postsynaptic fields of pyramidal cells. The MEG assessment will be conducted at baseline and immediately after treatment (3 weeks).
Time frame: baseline, 3 weeks
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