Stroke Clinical Trial
Official title:
A Pilot Feasibility Clinical Trial of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER) for postStroke Arm Paresis
A feasibility trial of Neurostyle Brain Exercise Therapy Towards Enhanced Recovery (nBETTER) system for Brain Computer Interface (BCI) neurofeedback for rehabilitation of the subacute and chronic hemiplegic upper limb aimed at improving upper limb recovery for subacute to chronic stroke patients.
Stroke remains the 4th cause of death in Singapore and despite advances in neuro-medical care
and rehabilitation, 40-50% of stroke survivors are left with permanent neuro-disability and a
reduced quality of life. The previous 2 decades has seen exponential leaps in the development
of rehabilitation technologies which enhance neuroplasticity and rehabilitation outcome. One
of these potentially useful technologies is nBETTER System, was developed by Institute for
Infocomm Research, Agency for Science, Technology and Research (A*STAR). nBETTER is a
portable, internet-connected device that detects the imagination of movement of
stroke-affected limb using a Electroencephalography (EEG)-based Brain-Computer Interface
(BCI) thus delivering visually engaging feedback for directed neurofeedback aimed at
improving upper limb recovery for subacute to chronic stroke patients. The pilot study aims
to recruit 13 patients using a multi centre trial design to investigate nBETTER system
feasibility and safety for rehabilitation of subacute to chronic stroke patients with upper
limb motor impairment and to determine clinical efficacy, safety and feasibility of such a
system when it is delivered with standard occupational therapy.
The investigators primary hypothesis is that nBETTER is a feasible and safe prototype in
stroke survivors (> 3 months) with moderate to severe arm impairment (FMMA 10-50). The
primary outcome is a gain of 15% in Fugl-Meyer motor scores at 6 weeks after 18 sessions
(total of 27 hours) of supervised training by occupational therapists and bioengineers.
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