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The specific study aims will be:
Part I: Validation of Treatment Efficacy of the New Digital MT System with Different MVF Conditions and Training Modes
In this new MT system, 3 different types of MT in different MVF conditions and training modes can be provided: unilateral MVF with unimanual training mode (UM-UT), unilateral MVF with bimanual training mode (UM-BT), and bilateral MVF with bimanual training mode (BM-BT). In the part â… study, an estimated total of 80 patients with stroke will be recruited. In addition to the original rehabilitation interventions of patients, each participant will be randomly allocated to 1 of 4 intervention groups (i.e., UM-UT, UM-BT, BM-BT, or traditional MT using a mirror box) for 15-hour therapy sessions. Outcome measures will be administrated at pre-treatment, immediately after treatment, and at 1-month follow-up after treatment.
Part II: Investigation of the Electrophysiological Mechanisms Underlying Different MVF Conditions by EEG
Twenty stroke patients will be recruited for examining the brain electrophysiological mechanisms underlying different types of MVF and training conditions of this new system by using electroencephalography (EEG). Three experimental conditions, including UM-UT, UM-BT, and BM-BT conditions, will be conducted in the EEG study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uni-MVF condition and unimanual training mode using the new MT system (UM-UT) | Experimental | The following common categories of upper-limb movements and actions will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movements, and (c) object manipulation. |
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| Uni-MVF condition and bimanual training mode using the new MT system (UM-BT) | Experimental | The following common categories of upper-limb movements and actions will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movements, and (c) object manipulation. |
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| Bi-MVF condition and bimanual training mode using the new MT system (BM-BT) | Experimental | The following common categories of upper-limb movements and actions will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movements, and (c) object manipulation. |
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| Traditional MT using a mirror box | Active Comparator | The following common categories of upper-limb movements and actions will be selected and included in this group: (a) active range of motion (AROM) exercises, (b) reaching movements, and (c) object manipulation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uni-MVF condition and unimanual training mode using the new MT system (UM-UT) | Behavioral | For the UM-UT group, the participants will be seated in front of the new MT system, and will be instructed to watch the real-time image reflection of movements of the non-affected arm and hand on the screen carefully. At the same time, the patients will need to imagine that the movements were performed by their affected arm and hand. In this group, only the non-affected arm and hand will need to perform the movements, but the affected one will not need to move. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| change scores of Revised Nottingham Sensory Assessment |
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Part â… : Validation of Treatment Efficacy of the New Digital MT System with Different MVF Conditions and Training Modes
Inclusion Criteria:
Exclusion Criteria:
Part II: Investigation of the Electrophysiological Mechanisms Underlying Different MVF Conditions by EEG
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu-Wei Hsieh, PhD | Department of Occupational Therapy, College of Medicine, Chang Gung University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lo-Sheng Sanatorium and Hospital | Taoyuan City | Taoyuan | 333 | Taiwan | ||
| Taoyuan Chang Gung Memorial Hospital |
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| Uni-MVF condition and bimanual training mode using the new MT system (UM-BT) | Behavioral | During the UM-BT, as similar as the first group (UM-UT), the participants will be also seated in front of the new MT system, and be instructed to watch the real-time image reflection of the non-affected arm and hand's movements on the screen carefully and imagine that the movements were performed by the affected arm. However, in this UM-BT group, the bilateral training mode is emphasized, and thus both arms and hands will need to move. That is, during therapy, the patient's affected arm and hand will be required to move at his/her best motor ability with the non-affected arm and hand at the same time. |
|
| Bi-MVF condition and bimanual training mode using the new MT system (BM-BT) | Behavioral | For the BM-BT group, the participants will be seated in front of this new MT system, and be instructed to observe the real-time image reflection of the non-affected arm and hand's movements transformed and superimposed on both arms and hands (i.e., bi-MVF), and to imagine that the movements were performed by both arms and hands. In this group, bi-MVF and bilateral training mode are emphasized, and thus both arms and hands will also need to move. The patient's affected arm and hand will be required to move as could as possible simultaneously. |
|
| Traditional MT using a mirror box | Behavioral | During traditional MT, the participants will be seated in front of a mirror box placed at their mid-sagittal plane. The affected arm and hand of the participants will be placed inside the mirror box, and the non-affected arm and hand will be in front of the mirror. As similar to the UM-UT group, the participants will be instructed to watch the mirror reflection of the movements performed by the non-affected arm and hand carefully and to imagine that the movements were performed by the affected arm and hand. In this group, the patient's affected arm and hand inside the mirror box will not need to move. |
|
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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Taoyuan City |
| 333 |
| Taiwan |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D002493 | Central Nervous System Diseases |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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