The Treatment Effectiveness of Theta Burst Stimulation and Voluntary Trunk Rotation for Patients With Unilateral Neglect in Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change score in Behaviorial Inattention Test (BIT) - Chinese version
研究概览
简要总结
This is a double blinded, randomized control trial with a pretest-posttest control and interventional group design. The assessor is blinded to all assessments and evaluations. All patients with subacute stroke undergo in-patient or out-patient rehabilitation are screened initially by a series of screening test. Suitable patients are assigned randomly to two groups respectively. Group 1 is the experimental group for Transcranial Magnetic Stimulation (TMS) and trunk rotation; Group 2 is the control group with only trunk rotation training and placebo stimulation.
详细描述
Methodology
Sampling:
Convenient sampling will be conducted to all in and out-patients with stroke referred consecutively to occupational therapy department in Kowloon Hospital during the data collection period. Patients who meet the following inclusion criteria are admitted for study.
Inclusion criteria
- First or second stroke (haemorrhagic or ischaemic) confirmed by computer axial tomography scan or magnetic resonance imaging
- Neurological representation compatible with a unilateral right lesion involvement (i.e. left hemiplegic), exhibited left visual field inattention or neglect by following either one of below criteria:
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First or second stroke (haemorrhagic or ischaemic) confirmed by computer axial tomography scan or magnetic resonance imaging
- •Neurological representation compatible with a unilateral right lesion involvement (i.e. left hemiplegic), exhibited left visual field inattention or neglect by following either one of below criteria:
- •obtaining a total score of star cancellation subtest in the conventional battery of the Behavioural Inattention Test <51 (out of 54)
- •obtaining a total score of line bisection subtest in the conventional battery of the Behavioural Inattention Test <7 (out of 9)
- •Score of Catherine Bergego Scale ≥ 1
- •Right handed
- •Less than six months since onset of stroke at study entry
- •Able to follow simple command
排除标准
- •Patients with severe dysphasia (either expressive or comprehensive) which restricts communication;
- •History of other neurological disease, psychiatric disorder, or alcoholism;
- •significant impairment in visual acuity caused by cataracts, diabetic retinopathy, glaucoma or hemianopia
- •Any additional medical or psychological condition that would affect their ability to comply with the study protocol.
结局指标
主要结局
Change score in Behaviorial Inattention Test (BIT) - Chinese version
时间窗: Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks), 4 weeks follow up after last session of treatment
assessment for unilateral neglect
次要结局
- Change score in Catherine Bergego Scale(Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks), 4 weeks follow up after last session of treatment)
- Change score in FTHUE-HK(Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks), 4 weeks follow up after last session of treatment)
- Change score in UE-Fugl Meyer(Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks), 4 weeks follow up after last session of treatment)
- Change score in FIM(Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks time), 4 weeks follow up after last session of treatment)
- Change score in SA-SIP 30(Day 0 (Date of initial assessment before treatment), Day 10 (Date after last session of treatment, expected average 3 weeks), 4 weeks follow up after last session of treatment)
研究者
Marko Chan
Occupational Therapist, PhD Candidate
Kowloon Hospital, Hong Kong