Effect of NEuroplasticity-Principles-based SEnsory-Rehabilitation (NEPSER) on sensori-motor recovery in stroke: study protocol for a randomized controlled trial

INTRODUCTION: Up to 2/3rd of the stroke subjects may experience impairment in any of the somatosensory modalities such as light touch, proprioception, and stereognosis. The sensory recovery is strongly associated with the level of motor recovery. Very negligible sensory-based interventions have been developed and found to be evident in enhancing the sensory deficit and associated motor recovery. The possible factor for the ineffectiveness of these sensory interventions could be lack of the neuroscientific basis in formulation of the program. Thus, the objective of the study is to determine the effectiveness of a neuralplasticity-principles-based sensory-rehabilitation protocol on motor and sensory recovery, and disability of the post-stroke hemiparetic subjects. METHODS: We propose to recruit 122 poststroke subjects in a randomized controlled, assessor blinded trial to be conducted in a rehabilitation-institute. The key eligibility criteria is age between 20 to 80 years, hemiparesis (right or left), ischemic or hemorrhagic stroke, 1 to 12 months poststroke, and impairment in any of the sensory modalities. The participants in the experimental group will receive NEuroplasticity-Principles-based SEnsory-Rehabilitation (NEPSER) protocol comprising active, repetitive, and meaningful training of the specific sensory modalities utilizing visuo-perceptual, cognitive, motor, and functional tasks will be imparted for 8 weeks, 5 sessions / week, each of 2 h. The control subjects will undergo only standard rehabilitation based on neurophysiological, biomechanical, and rehabilitative approaches. All the participants will be assessed for motor (Fugl-Meyer assessment, upper extremity section) and sensory recovery [Nottingham Sensory assessment (Erasmus MC modification of the revised version)] at baseline, 8-week, and 12-week follow-up. The Semmes weinstein monofilament, two-point discrimination test and modified rankin scale (disability) will be applied as secondary measures. A repeated-measures 2-way ANOVA will be used to estimate difference for the post intervention and follow-up scores between the groups. PERSPECTIVE: The proposed study will lead to development of a novel rehabilitation protocol that will not only enhance the sensory recovery but also the motor and functional recovery. This may reduce the impact of stroke disability and enhance the quality of life. TRIAL REGISTRATION: The trial has been registered under Clinical Trial Registry of India (CTRI) as CTRI/2019/09/021442 on 30th September 2019.