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临床试验/NCT04443127
NCT04443127Unknown不适用

Virtual Reality as a Motor Priming Tool for Cognitive-Motor Rehabilitation Among Sub-Acute Stroke Patients

Ziauddin University1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
62
试验地点
1
主要终点
Sensorimotor function of hemiplegic upper extremity (Pre-Treatment)

研究概览

简要总结

Stroke is the second leading global cause of mortality counting for 6.5 million deaths per annum. The global prevalence of stroke is increasing with an estimated prevalence of 33 million per year, affecting 1 out of 6 individuals during their lifetime. The international data suggests the overall economic burden in Asia is projected to be increased to 1.3 Billion by 2050. Therefore, the appropriate and timely stroke intervention is required to save healthcare costs and reduce the burden of the disease. Studies have reported the effectiveness of VR intervention not only in cognitive abilities but it has found to be simultaneously effective in improving other domains as attention and coordination with motor retraining. VR combined with a newly developed concept of motor priming has shown encouraging results in improving motor control and task execution in stroke patients. Further studies are needed to analyze the impact of motor priming with VR in stroke patients on varied neurological domains; hence the present study aims to investigate the impact of VR based motor priming on sensorimotor, functional and cognitive outcomes among sub-acute stroke patients rehabilitation.

详细描述

A total 62 patients will be recruited in the study. After voluntary consent, all the patients will be randomly divided into Group-A and B through the envelope method of simple random sampling. Patients in Group-A will be receiving VR based motor priming intervention while Group-B patients will be receiving Motor-Relearning Program as conventional therapy. Whereas, both the groups will be given 16 sessions of their respective protocol, comprising of 45 minutes, 4 times/week for the duration of 4 weeks. Pre and post assessment will be performed for each patient on all three quantitative outcome measures i.e. FMA-UE, CAHAI-13, and MoCA. A trial will be terminated, if the patient reported fatigue of >8 out of 10 on the Visual Analogue Scale, unable to execute movements, reports pain, eye strain, or signs of volitional fatigue in hemiplegic or non-hemiplegic extremities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female stroke patients aged 25-65 years
  • Patients who had an ischemic or hemorrhagic stroke in sub-acute phase of < 3 months
  • Mild cognitive impairment i.e. < 26 (19.0-25.2) on MoCA
  • Minimum Scoring of 28 in the Motricity Index

排除标准

  • Diagnosed visual-perceptual ailments which may restrict task execution
  • Communication disorders such as aphasia or dysarthria which may impede cognitive assessment
  • Comorbidities such as elevated blood pressure (>160mmhg/105 mmHg), heart diseases or chronic medical conditions
  • Major or active psychological illness and pre-existing dementia

结局指标

主要结局

Sensorimotor function of hemiplegic upper extremity (Pre-Treatment)

时间窗: Baseline

Sensorimotor function will be assessed through Fugl-Meyer Assessment Test where high values indicates increase in sensoimotor function

Sensorimotor function of hemiplegic upper extremity (Post-Treatment)

时间窗: After 4 weeks

Sensorimotor function will be assessed through Fugl-Meyer Assessment Test where high values indicates increase in sensoimotor function

Functional ability of hemiplegic upper extremity (Pre-Treatment)

时间窗: Baseline

Functional ability will be assessed through Chedoke Arm and Hand Activity Inventory-13 where high values indicates increase in Functional ability

Functional ability of hemiplegic upper extremity (Post-Treatment)

时间窗: After 4 weeks

Functional ability will be assessed through Chedoke Arm and Hand Activity Inventory-13 where high values indicates increase in Functional ability

Cognitive Function (Pre-Treatment)

时间窗: Baseline

Cognitive Function will be assessed using Montreal Cognitive Assessment where high values indicates increase in Cognitive Function

Cognitive Function (Post-Treatment)

时间窗: After 4 weeks

Cognitive Function will be assessed using Montreal Cognitive Assessment where high values indicates increase in Cognitive Function

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaza Rizvi

Principal Invesitgator

Ziauddin University

研究点 (1)

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