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.
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.
1. First or second stroke (haemorrhagic or ischaemic) confirmed by computer axial tomography scan or magnetic resonance imaging
2. 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 Behavioral Inattention Test <51 (out of 54)
- obtaining a total score of line bisection subtest in the conventional battery of the Behavioral Inattention Test <7 (out of 9)
- Score of Catherine Bergego Scale ≥ 1
3. Right handed
4. Less than six months since onset of stroke at study entry
5. Able to follow simple command
1. Patients with severe dysphasia (either expressive or comprehensive) which restricts communication;
2. History of other neurological disease, psychiatric disorder, or alcoholism;
3. significant impairment in visual acuity caused by cataracts, diabetic retinopathy, glaucoma or hemianopia
4. Any additional medical or psychological condition that would affect their ability to comply with the study protocol.
Data Collection and Treatment Procedures Written consent is obtained from all subjects before the randomization. All patients in both the experimental and placebo groups undergo the same rehabilitation process. Subject's demographic data are collected; they include age, gender, lesion site, educational level, time after onset of stroke, and global cognitive status as defined by the Mini-mental State Examination - Chinese version (CMMSE). Repeated measurements are done at day 0 (date for initial assessment), day 10 (end of treatment) and post 4 weeks. Assessments including Behavioral Inattention Test (BIT) - Chinese version, Catherine Bergego Scale, Functional Test for the hemiplegic upper extremity (FTHUE-HK), Upper-extremity portion of the Fugl-Meyer Scale (UE-FM), Functional Independence Measure (FIM), Stroke Adapted 30 item version of the Sickness Impact Profile (SA-SIP 30) score will be done at these intervals by a blind assessor.
Treatment sessions for the experimental groups and control groups are conducted by trained investigator for transcranial magnetic stimulation (TMS) and the case therapists. Patients in all groups receive 1 hour of the conventional treatment in Occupational Therapy each day. There are about 3-5 days of treatment per week for 10 days. The conventional treatment would consist of 45 minutes of voluntary trunk rotation exercise using set-up equipment as well as 15 minutes of activities of daily living (ADL) training.
For trunk rotation training, we would adopt our previous protocol (Fong et al., 2007). Voluntary trunk rotation was mediated by voluntarily rotating the trunk 15-35 degrees from the vertical midline toward the neglect side within the peripersonal space. The crucial element is that the upper trunk initiated the rotation by activating the ipsilesional upper extremity, which moved across the midline of the body to the contralesional space by visual spatial motor cueing, using traditional set-up apparatus such as shoulder arcs or wooden pegboards. The purpose of the apparatus was to provide a medium within the peripersonal space by which the trunk rotation could be initiated by patients. Trunk rotation was performed in three different positions: supine lying on a plinth, unsupported sitting on a plinth, and standing in a standing frame so that the intervention could facilitate both the visual attention and postural control through rotation of the trunk toward the contralesional side independent of the position of the patient.
For TMS protocol, we will make reference to the protocol developed by Cazzoll et al. (2012). Continuous theta burst stimulation (TBS) was applied by means of a MagPro X100 stimulator (Medtronic Functional Diagnostics) connected to a round coil with 60 mm outer radius (Magnetic Coil Transducer MC-125). In brief, the continuous TBS protocol comprised 801 pulses, delivered in a continuous train and consisting of 267 bursts. Each burst contained three pulses at 30 Hz, repeated at 6 Hz. The total duration of one single, continuous TBS train was 44s. Overall, eight continuous TBS trains were applied over 2 days. Four continuous TBS trains were applied on Day 1 (two continuous TBS trains with an interval of 15 min, the third and the fourth train 60 and 75 min after the first continuous TBS train, respectively) and four continuous TBS trains on Day 2 (same time intervals as for Day 1). Continuous TBS was applied over P3, according to the International 10-20 EEG System. This site overlies the posterior parietal cortex in proximity of the intraparietal sulcus. The coil was held tangentially to the scalp, with the handle pointing posteriorly, the current flowing clockwise as viewed from above. The patients were asked to close their eyes during continuous TBS application. Continuous TBS was delivered at 100% of patients' individual resting motor threshold.
- TMS and trunk rotation Device
Intervention Desc: TMS and trunk rotation ARM 1: Kind: Experimental Label: TMS and trunk rotation Description: TMS and trunk rotation
- Sham TMS and trunk rotation Device
Intervention Desc: Sham TMS and trunk rotation ARM 1: Kind: Experimental Label: Sham TMS and trunk rotation Description: Sham TMS and trunk rotation
- Allocation: Randomized
- Masking: Double Blind (Subject, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Change score in Behaviorial Inattention Test (BIT) - Chinese version||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||No|
|Secondary||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||No|
|Secondary||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||No|
|Secondary||Change score in UE-Fugl Meyer||No|
|Secondary||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||No|
|Secondary||Change score in SA-SIP 30||No|