Digital Mirror Therapy With Uni- and Bilateral Mirror Visual Feedback After Stroke: Treatment Effects and EEG Evidence
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The specific study aims will be:
- 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.
- 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.
Full description
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 Ⅰ 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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Inclusion and exclusion criteria
Part Ⅰ: 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
Trial design
Primary purpose
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Interventional model
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47 participants in 4 patient groups
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Central trial contact
Yu-Wei Hsieh, PhD
Data sourced from clinicaltrials.gov
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