Investigate the Effectiveness of Augmented Reality and Repetitive Transcranial Magnetic Stimulation Technology in Persons With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change of Time Up Go test (TUG)
研究概览
简要总结
This study is to investigate the combined effects of repetitive Transcranial Magnetic Stimulation (rTMS) and Augmented Reality (AR) intervention on cortical excitability, balance, gait, activity in individuals with stroke. Forty participants will be recruited in this study. They will be allocated to four group: rTMS and AR group (10), sham rTMS and AR group (10), AR group (10), and conventional physiotherapy group (10).
详细描述
Participants will be randomized allocated to four groups: rTMS and AR group, sham rTMS and AR group, AR group ,and conventional physiotherapy group in current study. All participants underwent four weeks, 3 sessions per week, and 60 minutes per session training program. Motor evoked potential (MEP), Time up go test (TUG), Berg Balance Scale (BBS), Fugl-Meyer Assessment (FMA), Multi-directional Reach Test (MDRT),The Postural Assessment Scale for Stroke Patients (PASS), and Taiwanese Depression Questionnaires (TDQ) will be assessed before and after intervention in all participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Cognitive ability is sufficient to understand the nature of study (Mini-Mental State Examination score was above 23).
- •Participants suffer from unilateral hemiplegia caused by a first-ever stroke.
- •Participants are stable in medical and psychological condition.
排除标准
- •Participants have other neurologic problems that can affect balance and walking ability.
- •Participants take of drugs or have other medical condition that can affect balance and function.
- •Participants have contraindications for rTMS intervention such as pacemaker, cochlear implants, metal in the brain or skull, open wound of brain, or history of epilepsy.
研究组 & 干预措施
rTMS and AR group
Ten participants in group A will undergo repetitive transcranial magnetic stimulation (real, 1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks.
干预措施: rTMS and AR (Behavioral)
Sham rTMS and AR group
Ten participants in group B will receive repetitive transcranial magnetic stimulation (sham,1 Hz, 15 minutes), follow by a session of augmented reality exercise (45 minutes), 3 days per week for 4 weeks.
干预措施: Sham rTMS and AR (Behavioral)
AR group
Ten participants in group C will undergo augmented reality exercise 60 minutes a day and 3 days per week for four weeks.
干预措施: AR (Behavioral)
Conventional physiotherapy group
Ten participants allocated to the group D will receive conventional physiotherapy 60 minutes a day and 3 days per week for four weeks.
干预措施: Conventional physiotherapy (Behavioral)
结局指标
主要结局
Change of Time Up Go test (TUG)
时间窗: Measurement before and after intervention ( week 0 and at the end of week 4) in four groups
The TUG test will ask participants to stand up, walk for 3 m, turn, walk back and sit down as fast as they can during the test, and the time requires for each patient to complete the test is recorded.
次要结局
- Change of Berg Balance Scale (BBS)(Measurement before and after intervention ( week 0 and at the end of week 4) in four groups)
- Change of Motor evoked potential (MEP)(Measurement before and after intervention ( week 0 and at the end of week 4) in four groups)
- Change of Fugl-Meyer Assessment (FMA)-Lower extremity(Measurement before and after intervention ( week 0 and at the end of week 4) in four groups)
- Change of Multi-directional Reach Test (MDRT)(Measurement before and after intervention ( week 0 and at the end of week 4) in four groups)
- Change of The Postural Assessment Scale for Stroke Patients (PASS)(Measurement before and after intervention ( week 0 and at the end of week 4) in four groups)
- Change of Taiwanese Depression Questionnaires (TDQ)(Measurement before and after intervention ( week 0 and at the end of week 4) in four groups)
研究者
Lai chien hung
Professor
Taipei Medical University Hospital