CUHK_CCT00371
2013-06-14
Prospective
CRE-2012.514-T
NA
Division of Neurology, Department of Medicine & Therapeutics, The Chinese University of Hong Kong
NA
Not Applicable
Roxanna LIU
Division of Neurology, Dept of Medicine and Therapeutics,PWH
3505 3877
roxannaliu@cuhk.edu.hk
Division of Neurology, Dept of Medicine and Therapeutics,PWH,CUHK
Hong Kong
Ka Sing WONG
Division of Neurology, Dept of Medicine and Therapeutics,PWH
3505 3877
ks-wong@cuhk.edu.hk
Dept of Medicine and Therapeutics, PWH,CUHK
Hong Kong
A randomized controlled trial of transcranial magnetic stimulationand robotic-hand therapy to improve hand function after ischemic stroke
A randomized controlled trial of transcranial magnetic stimulationand robotic-hand therapy to improve hand function after ischemic stroke
機械手及經顱磁刺激聯合療法對中風病人手部運動功能康復的研究
TBS-ROBOT
HK, CHINA
Yes
2013-01-22
Joint CUHK-NTEC Clinical Research Ethics Committee
2012.514-T
stroke
Device
transcranial magnetic stimulation &
robotic-hand therapy
NA
NA
3 min for TBS, 45 min for hand therapy
10 sessions for TBS ,20 sessions for robotic-hand therapy
sham transcranial magnetic stimulation
NA
NA
3 min for TBS, 45 min for hand therapy
10 sessions for TBS ,20 sessions for robotic-hand therapy
1) patients aged 18 or above; 2) first-ever ischemic subcortical stroke with onset time less than 21 days; 3) hand weakness as a result of stroke; 4) intracerebral hemorrhage excluded by brain computed tomography (CT) / magnetic resonance imaging (MRI) ; 5) the patient or his/her legally acceptable representative is willing to provide written informed consent.
1) personal history of epilepsy; 2) metallic implants in any part of body; 3) implanted cardiac pacemaker, defibrillator, medication pump or any other implanted electronics; 4) severe skull fracture, serious head injury, history of brain or spinal cord surgery; 5) brain tumour or other significant non-ischemic brain lesion on CT/MRI; 6) administration of drugs that potentially lower seizure threshold; 7) severe hand spasticity, open hand wound or hand deformity; 8) history of malignancy; 9) severe co-existing systemic diseases, severe dementia or psychosis; 10) inability to be followed up at regular interval; 11) pregnancy or breast-feeding
18
90
Both Male and Female
Interventional
Randomized
double blinded
Placebo
Not Applicable
Parallel
0
2013-07-01
63
Suspended
Upper limb fugl-meyer assessment (FMA)at week 12 after stroke
RMT, AMT, MEP, S/R curve, Power Grip, Lateral Pinch Grip, Purdue Pegboard for both hands ,NIHSS,mRS at baseline,week 4, week 8, week 12, week 24 after stroke.
2017-04-25
ChiCTR-TRC-13003417
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