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Clinical Trial Summary

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04813120
Study type Interventional
Source Chang Gung Memorial Hospital
Contact Yu-Wei Hsieh, PhD
Phone +886-3-2118800
Email ywhsieh@mail.cgu.edu.tw
Status Recruiting
Phase N/A
Start date August 1, 2021
Completion date July 31, 2024

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