Kowloon Hospital
Kowloon, Hong Kong
NCT Number: NCT02526238
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.
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Interventional
Not applicable
Kowloon, Hong Kong
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
Exclusion criteria
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. 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TMS and trunk rotation
Sham TMS and trunk rotation
Time frame: 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
Time frame: 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
Time frame: 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 upper limb function
Time frame: 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 upper limb function
Time frame: 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
assessment for activities of daily living
Time frame: 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 well being
Kowloon Hospital, Hong Kong
Other
The Treatment Effectiveness of Theta Burst Stimulation and Voluntary Trunk Rotation for Patients With Unilateral Neglect in Stroke
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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