Stroke Clinical Trial
Official title:
Action Observation, Imagery and Execution as a New Intervention Strategy for Stroke Rehabilitation: Short- and Long-term Treatment Effects and Neural Mechanism
Verified date | June 2020 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | July 31, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | Inclusion Criteria: - diagnosed as having a unilateral stroke; - 1 to 12 months after stroke onset - from 20 to 80 years of age - a baseline score of the Fugl-Meyer Assessment (FMA) of 20 to 60 - able to follow the study instructions - capable of participating in therapy and assessment sessions. Exclusion Criteria: - patients with global or receptive aphasia, - severe neglect - major medical problems, or comorbidities that influenced UE usage or caused severe pain Additionally, if patients have no metal implants, no head traumas or neurosurgical operations, and can perform MEG motor tasks, the participants can additionally participate in the MEG assessment. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei medical university hospital | Taipei | |
Taiwan | Taipei Medical University Shuang Ho Hospital | Taipei | |
Taiwan | Lo-Sheng Sanatorium and Hospital, Ministry of Health and Welfare | Taoyuan City | |
Taiwan | Taoyuan Chang Gung Memorial Hospital | Taoyuan City |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change scores of Modified Rankin Scale | The Modified Rankin Scale is used to assess the degree of stroke disability. | baseline, 3 weeks , 3 months | |
Primary | Change scores of Fugl-Meyer Assessment | Change from baseline motor impairment at 3 weeks on the Fugl-Meyer Assessment. | baseline, 3 weeks , 3 months | |
Secondary | 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. | baseline, 3 weeks , 3 months | |
Secondary | Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI) | The CAHAI measures the upper-limb motor function after stroke. | baseline, 3 weeks , 3 months | |
Secondary | Change scores of Movement Imagery Questionnaire, revised second version | The MIQ-RS will be applied to assess patient's ability of motor imagery. | baseline, 3 weeks , 3 months | |
Secondary | Change scores of Functional Independence Measure | The Functional Independence Measure is a frequently used scale to assess basic activities of daily function. | baseline, 3 weeks , 3 months | |
Secondary | 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. | baseline, 3 weeks , 3 months | |
Secondary | 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. | baseline, 3 weeks , 3 months | |
Secondary | 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. | baseline, 3 weeks , 3 months | |
Secondary | 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). | baseline, 3 weeks |
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