【ChiCTR2200060093】Investigating effect of sensorimotor and gait training with biofeedback on lower-limb proprioception and motor function of stroke survivors

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基本信息

登记号

ChiCTR2200060093

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2022-05-18

临床申请受理号

靶点

适应症

Stroke

试验通俗题目

Investigating effect of sensorimotor and gait training with biofeedback on lower-limb proprioception and motor function of stroke survivors

试验专业题目

Investigating effect of sensorimotor and gait training with biofeedback on lower-limb proprioception and motor function of stroke survivors

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临床试验信息

试验目的

Stroke is a common and disabling disease, bringing great challenges to medical systems globally. The long-term effects of a stroke can affect the quality of life of community-dwelling stroke survivors and their ability to participate in life roles. Nearly two-thirds of stroke survivors exhibit various forms of somatosensory or proprioceptive dysfunction. Previous neurofacilitation interventions to improve the impaired lower-limb proprioception and motor function like Bobath and Proprioceptive Neuromuscular Facilitation (PNF), have not been able to show better effect on motor performance after stroke than any other treatment methods, and long-term improvements in walking performance are lacking. Some recent studies have developed and applied some assistive devices specifically to do the sensorimotor training, with advanced interaction control schemes and the use of integrated sensors to continuously monitor and adapt the support to the actual state of patients. However, to the best of our knowledge, none of the previous studies have investigated if the sensorimotor and gait training can improve the lower-limb proprioception and motor function in stroke survivors. To address the above-mentioned issues, this study will fill the research gap by investigating the effect of sensorimotor and gait training on lower-limb proprioception and motor function of stroke survivors. It will apply a novel wearable biofeedback system with feedback on lower-limb motion to do the sensorimotor and gait training and investigate the immediate effect of such trainings on lower limb proprioception and motor function of stroke survivors.

试验分类

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试验类型

随机交叉对照

试验分期

探索性研究/预试验

随机化

Participants who meet the enrollment criteria will be assigned to receive two assessment sessions with two different interventions, sensorimotor and gait training with the biofeedback system on and off, in a random order with a 1-day washout interval between sessions.

盲法

Double-blinded

试验项目经费来源

The Hong Kong Polytechnic University

试验范围

目标入组人数

实际入组人数

第一例入组时间

2021-09-01

试验终止时间

2023-08-31

是否属于一致性

入选标准

1. Capacity for comprehending the research aims and procedure and for complying with basic orders, based on evaluation through the Mini-Mental State Examination (MMSE>24); 2. Medical condition stability to allow for more than one session of physical training; 3. At least 6 months after the onset of a singular and unilateral stroke; 4. Have detectable voluntary EMG from the target muscles; 5. Have normal hearing function for normal communication.；

排除标准

1. Have vestibular or neurological diseases; 2. Severe cardiovascular disease, diabetes or lung-related diseases; 3. Had foot injury before; 4. Currently pregnant.；

研究者信息

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试验机构

The Hong Kong Polytechnic University

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