Multi-sensory feedback therapy combined with task-oriented training on the hemiparetic upper limb in chronic stroke: study protocol for a pilot randomized controlled trial

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Abstract
Background An important reason for the difficulty in recovering sensorimotor dysfunction of the upper extremity in chronic stroke survivors, is the lack of sensory function, such as tactile and proprioception feedback. In clinical practice, single sensory training is only for the restoration of sensory function. Increasing evidence suggests that use of task-oriented training (TOT) is a useful approach to hand motor rehabilitation. However, neither approach is optimal since both methods are trained only for specific functional recovery. Our hypothesis is that multi-sensory feedback therapy (MSFT) combined with TOT has the potential to provide stimulating tasks to restore both sensory and motor functions. The objective of the trial is to investigate whether novel MSFT is more effective in improving arm sensorimotor function in chronic stroke phase than single TOT.Methods/Design: The study will be conducted as a multicenter, randomized, double blind controlled trial. Participants (n = 90) will be randomised into three groups to compare the effect of the multi-sensory feedback therapy group against task-oriented training group and conventional group. Participants will receive treatment at the same intensity (60 min, 5 days a week, 4 weeks, 20 hours total). Primary outcome measures for assessment of sensory function are the Semmes Weinstein monofilaments examination (SWME),two-point discrimination test (2PD) test. Secondary measures are the Action Research Arm Test (ARAT)༌Nine-Hole Peg Test (NHPT), Wolf Motor Function Test (WMFT), Box and Blocks Test (BBT), Modified Barthel Index (MBI), Instrumental activities of daily living (IADL) and Generalized Anxiety Disorder 7-Item Scale (GAD-7). Outcome mearsures will be evaluated at baseline, post treatment, and two months follow-up. All assessments will be conducted by trained assessors blinded to treatment allocation.Discussion This study will determine the acceptability and efficacy of the intervention on the hemiparetic upper limb, it may be promising tools for sensorimotor functional recovery after stroke.

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