NCT Number: NCT02871700
The specific aims of this study will be to:
1. investigate the treatment efficacy of Action observation therapy (AOT), mirror therapy (MT) versus a control intervention on motor and functional outcomes of stroke patients. 2. compare the mechanisms and changes in cortical neural activity after AOT, MT, and control intervention by using magnetoencephalography (MEG). 3. determine the correlations between neural activation changes and clinical outcomes after AOT and MT. 4. identify who are the potential good responders to AOT and MT.
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Notify Me20 year–80 year
All sexes
Interventional
Not applicable
Cathay General Hospital (Taipei and Sijhi), Taipei, Taiwan
In this 3-year study project, the investigators will design a comparative, randomized controlled trial to (1) investigate the treatment efficacy of AOT, MT versus a control intervention on motor and functional outcomes of stroke patients, (2) compare the mechanisms and changes in cortical neural activity after AOT, MT, and control intervention by using magnetoencephalography (MEG), (3) determine the correlations between neural activation changes and clinical outcomes after AOT and MT, and (4) identify who are the potential good responders to AOT and MT. An estimated total of 90 patients with subacute stroke will be recruited in this study. All participants will be randomly assigned to receive AOT, MT, or control intervention for a 3-week training period (a total of 15 sessions). Outcome measures will be conducted at baseline, immediately after treatment, and 3 months follow-up. For the MEG study, the investigators anticipate to recruit 12 to 15 patients in each group. The patients can still participate in this study to receive treatments and clinical evaluations even if they do not meet the MEG eligibility criteria or are not willing to participate in the MEG study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patients were asked to observe everyday life actions of which they had motor experience or the actions belong to the motor repertoire of observers', they had better performance. The common categories of motor actions and tasks for stroke patients are selected in this study: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-extremity (UE) functional tasks practice.
The MT group will receive 60 minutes of upper-limb training in a mirror box. MT treatment activities will include AROM exercises (10 to 15 minutes), reaching movement or object manipulation (15 to 20 minutes), and functional tasks practice (30 minutes) in a mirror box.
The participants in this group will receive dose-matched customary bilateral UE training programs for 1 hour per session. The treatment protocol of control group will also include: (a) AROM exercises (10 to 15 minutes), (b) reaching movement or object manipulation (15 to 20 minutes), and (3) functional tasks practice (30 minutes).
Time frame: baseline, 3 weeks , 3 months
Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment.
Time frame: baseline, 3 weeks , 3 months
The Modified Rankin Scale is used to assess the degree of stroke disability.
Time frame: baseline, 3 weeks , 3 months
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
The Wolf Motor Function Test was initially developed to assess the effect of constraint-induced movement therapy. Through the timed score, function score and grip score to quantify upper extremity motor function in people with stroke.
Time frame: baseline, 3 weeks , 3 months
The muscle power of the affected arm will be examined by the Medical Research Council scale.
Time frame: baseline, 3 weeks , 3 months
The Motor Activity Log consists of 30 structured questions to interview how the patients rate the frequency (amount of use subscale) and quality (quality of movement subscale) of movements while using their affected arm to accomplish 30 daily activities.
Time frame: baseline, 3 weeks , 3 months
The Chedoke Arm and Hand Activity Inventory is a new measurement development for assessing upper extremity function after stroke.
Time frame: baseline, 3 weeks , 3 months
The Revised Nottingham Sensory Assessment includes the assessment of tactile sensation, kinesthetic sensation, and stereognosis and is a reliable measure of sensory function in stroke patients.
Time frame: baseline, 3 weeks , 3 months
The ABILHAND Questionnaire is a self-reported and Rasch-based scale that assesses patients' perceived difficulty in performing daily activities that require the use of the bilateral UE.
Time frame: baseline, 3 weeks , 3 months
The short-form of Questionnaire Upon Mental Imagery is applied to assess patient's ability of mental imagery.
Time frame: baseline, 3 weeks , 3 months
The Functional Independence Measure is a frequently used scale to assess basic activities of daily function.
Time frame: baseline, 3 weeks , 3 months
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
The accelerometers (ActiGraph) are used to provide an objective measure of the amount of the affected arm in patient's real-life environments. The main outcome parameters will be the average intensity of physical activity (counts/minute), types of activity, and energy expenditure(Kcal) in real life.
Time frame: baseline, 3 weeks
Magnetoencephalography can directly measure cortical neural activity and detect the oscillatory signals mainly by the changes in the postsynaptic fields of pyramidal cells
Time frame: baseline, 3 weeks
Patient-reported pain on the Visual Analogue Scale
Time frame: baseline, 3 weeks
Patient-reported fatigue on the Visual Analogue Scale
Chang Gung Memorial Hospital
Other
Comparative Efficacy Study of Action Observation Therapy and Mirror Therapy After Stroke: Rehabilitation Outcomes and Neural Mechanisms by MEG
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