Arya Kamal Narayan, Pandian Shanta, Agarwal G G, Chaudhary Neera, Joshi Akshay Kumar
Department of Occupational Therapy, Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities, 4 Vishnu Digamber Marg, New Delhi, 110002, India.
Department of Statistics, Lucknow University, Lucknow, India.
Neurol Res Pract. 2021 Feb 4;3(1):8. doi: 10.1186/s42466-021-00108-1.
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.
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.
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.
The trial has been registered under Clinical Trial Registry of India (CTRI) as CTRI/2019/09/021442 on 30th September 2019.
多达三分之二的中风患者可能会在任何一种躯体感觉模式上出现损伤，如轻触觉、本体感觉和实体觉。感觉恢复与运动恢复水平密切相关。目前针对感觉障碍所开展的干预措施少之又少，而且在改善感觉缺陷及相关运动恢复方面的效果也不明显。这些感觉干预措施无效的可能原因在于方案制定过程中缺乏神经科学依据。因此，本研究的目的是确定基于神经可塑性原理的感觉康复方案对中风后偏瘫患者运动和感觉恢复以及残疾状况的有效性。
我们计划在一家康复机构开展一项随机对照、评估者盲法试验，招募122名中风后患者。主要纳入标准为年龄在20至80岁之间、偏瘫（右侧或左侧）、缺血性或出血性中风、中风后1至12个月以及存在任何一种感觉模式损伤。实验组的参与者将接受基于神经可塑性原理的感觉康复（NEPSER）方案，包括利用视觉感知、认知、运动和功能任务对特定感觉模式进行主动、重复且有意义的训练，为期8周，每周5次，每次2小时。对照组仅接受基于神经生理学、生物力学和康复方法的标准康复治疗。所有参与者将在基线、8周和12周随访时接受运动（Fugl-Meyer评估，上肢部分）和感觉恢复[诺丁汉感觉评估（修订版的伊拉斯姆斯医学中心改良版）]评估。Semmes weinstein单丝、两点辨别试验和改良Rankin量表（残疾程度）将作为次要测量指标。采用重复测量双向方差分析来估计两组干预后及随访评分的差异。
本研究有望开发出一种新型康复方案，不仅能促进感觉恢复，还能促进运动和功能恢复。这可能会减轻中风残疾的影响，提高生活质量。
该试验已于2019年9月30日在印度临床试验注册中心（CTRI）注册，注册号为CTRI/2019/09/021442。
