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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 4
- 主要终点
- Change scores of Fugl-Meyer Assessment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change scores of Fugl-Meyer Assessment
时间窗: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
The upper-limb subsection of Fugl-Meyer Assessment is a measure with sound psychometric properties to evaluate motor impairments.
Change scores of Chedoke Arm and Hand Activity Inventory
时间窗: baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2)
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.
次要结局
- change scores of Barthel Index(baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2))
- change scores of Motor Activity Log(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(baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2))
- change scores of Revised Nottingham Sensory Assessment(baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2))
- change scores of Box and Block Test(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(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(baseline (T0), at the end of 4 weeks of intervention (T1) , and 1 month after intervention (T2))