Stroke Clinical Trial
Official title:
The Use of a New Digital Mirror Therapy System Providing Unilateral and Bilateral Mirror Visual Feedback for Patients With Stroke: Treatment Effects and EEG-physiological Evidence
The specific study aims will be: 1. To examine the treatment effects of a new digital mirror therapy (MT) system versus a mirror box in patients with stroke by conducting a 4-group randomized controlled trial. 2. To examine the electrophysiological mechanisms of uni-mirror visual feedback (uni-MVF) condition with unimanual training mode, uni-MVF condition with bimanual training mode, and bi-MVF condition with bimanual training mode in the new MT system by EEG.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | July 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | Part ?: Validation of Treatment Efficacy of the New Digital MT System with Different MVF Conditions and Training Modes Inclusion Criteria: - diagnosed with a unilateral stroke; - at least 6 months after stroke onset; - age between 20 and 80 years old; - having a baseline score of Fugl-Meyer Assessment (FMA) in a range of 20 to 60; - able to follow the study instructions; - capable of participating in therapy and assessment sessions Exclusion Criteria: - global or receptive aphasia; - severe neglect measured by line bisection test; - other major medical diseases or comorbidities that have influenced upper-limb usage or caused severe pain Part II: Investigation of the Electrophysiological Mechanisms Underlying Different MVF Conditions by EEG Inclusion Criteria: - diagnosed with a unilateral stroke; - at least 2 weeks after stroke onset and medical stable; - aged 20 to 80 years; - having a baseline score of FMA = 40 and wrist flexion = 20 degrees in order to perform EEG motor tasks; - both wrist flexion and extension scores of Modified Ashworth Scale = 1; - able to follow the study instructions Exclusion Criteria: - global or receptive aphasia; - severe neglect measured by line bisection test; - other major medical diseases or comorbidities, such as neurological and psychiatric diseases, that have caused severe pain of upper-limb or interfered brain neural activities |
Country | Name | City | State |
---|---|---|---|
Taiwan | Lo-Sheng Sanatorium and Hospital | Taoyuan City | Taoyuan |
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 Fugl-Meyer Assessment | The upper-limb subsection of Fugl-Meyer Assessment is a measure with sound psychometric properties to evaluate motor impairments. | baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2) | |
Primary | Change scores of Chedoke Arm and Hand Activity Inventory | The Chedoke Arm and Hand Activity Inventory is a reliable and validated measure to assess the independence of stroke patients to perform activities of daily living with an affected upper limb. | baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2) | |
Secondary | change scores of Box and Block Test | The Box and Block Test is a tool with sound reliability and validity to evaluate hand dexterity of stroke patients. | baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2) | |
Secondary | change scores of Revised Nottingham Sensory Assessment | The Revised Nottingham Sensory Assessment is a standardized measure with good reliability to assess sensory function in patients with stroke. | baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2) | |
Secondary | change scores of Movement Imagery Questionnaire-Revised, Second Edition | The Movement Imagery Questionnaire-Revised, Second Edition is a 14-item questionnaire with sound reliability and validity to evaluate the ability of motion imagination in patients with stroke. | baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2) | |
Secondary | change scores of Barthel Index | The Barthel Index is a validated tool designed to measure activities reflecting the daily living independence. | baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2) | |
Secondary | change scores of Motor Activity Log | The Motor Activity Log is a semi-structured interview with good psychometric properties to assess the level of use of affected upper limb in 30 main activities of daily living. | baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2) | |
Secondary | change scores of the health state of EQ-5D-5L | The questionnaire of EQ-5D-5L contains 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and uses a 5-point Likert scale scored from 1 (no problem) to 5 (unable to/extreme problems); whereas, the numerical description of 5 dimensions represents the health state. | baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2) | |
Secondary | change scores of the visual analogue scale (VAS) of EQ-5D-5L | The VAS of EQ-5D-5L scores will be scored from 0 to 100, with a higher score indicating better overall current health. | baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2) |
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