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临床试验/NCT05133219
NCT05133219已完成不适用

The Effect of ıntensified Sensory-based Therapy on Upper Extremity Functions and Activities of Daily Living in Patients With Chronic Stroke

Kocaeli University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Canadian Occupational Performance Measure (COPM)- Satisfaction

研究概览

简要总结

Sensory dysfunction following stroke is a common condition. The deficiency in the somatosensory system negatively affects the learning of new motor skills by preventing feedback from the sensory system, and it can also cause problems in daily life, personal care, productivity, and leisure activities. Somatosensory impairment is often overlooked, as rehabilitation often focuses on motor abilities in the affected extremity. In the studies reviewed, it is stated that sensory dysfunction is seen in approximately 50% of stroke patients.

The aim of this study is to examine the effects of intensified sensory-based therapy applied to the affected upper extremity sensory functions in individuals with chronic stroke on the upper extremity functions, quality of life, and independence of daily living activities.

详细描述

Sensory dysfunction following stroke is a common condition. The deficiency in the somatosensory system negatively affects the learning of new motor skills by preventing feedback from the sensory system, and it can also cause problems in daily life, personal care, productivity, and leisure activities. Somatosensory impairment is often overlooked, as rehabilitation often focuses on motor abilities in the affected extremity. In the studies reviewed, it is stated that sensory dysfunction is seen in approximately 50% of stroke patients.

The aim of the study; The aim of this study is to examine the effects of intensified sensory-based therapy applied to the affected upper extremity sensory functions in individuals with chronic stroke on the upper extremity functions, quality of life, and independence of daily living activities.

Thirty patients with chronic stroke will be randomized 1:1 to study (n:15) and control (n=12). Thumb localization test, finger swipe test, stereognosis test, and two-point discrimination test will be used to evaluate the sensory functions of individuals. Demographic information of individuals will be recorded with a sociodemographic information form. Before the treatment, the sensory levels of all patients will be determined by thumb localization, finger scrolling and stereognosy tests. Jebsen Taylor Hand Function Test (JTHFT), Modified Frenchay Scale (MFS), Canadian Occupational Performance Measure (COPM), Goal Attainment Scale (GAS) and Stroke-Specific Quality of Life Scale (SSQOL) will be administered before and after treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stroke duration more than 6 months,
  • To be able to communicate
  • 10 degrees of wrist dorsiflexion starting from full palmar flexion of the wrist
  • To initiate finger extension

排除标准

  • Joint contracture in the upper and lower extremities that will affect functionality other than stroke,
  • Having a significant uncontrolled health problem and a history of epileptic seizures,
  • Having 3 or more spasticity according to the Modified Ashworth Scale (MAS),
  • Unable to communicate and cooperate,
  • With marked ataxia and dystonia,
  • Lack of movement and function in the wrist and fingers
  • Having a diagnosis of bilateral stroke

结局指标

主要结局

Canadian Occupational Performance Measure (COPM)- Satisfaction

时间窗: 3 weeks

Used to evaluate participants' self-perceived satisfaction with performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their satisfaction of how well they are able to complete each task on a scale of 1 (unsatisfied) to 10 (completely satisfied). Total scores are an mean of individual task scores and also range from 1 (unsatisfied) to 5 (completely satisfied). Collected data will be used to measure changes within and between groups on self-perceived satisfaction with performance between week 1 and 8, week 1 and 3.

Canadian Occupational Performance Measure (COPM)- Performance

时间窗: 3 weeks

Used to evaluate participants' self-perceived functional performance. In this structured interview, participants are asked to select 5 tasks to perform and then rate their perception of how well they are able to complete each task on a scale of 1 (unable to perform) to 10 (able to perform extremely well). Total scores are an mean of individual task scores and also range from 1 (unable to perform tasks) to 5 (able to perform tasks extremely well). Collected data will be used to measure changes within and between groups on self-perceived performance between week 1 and 3.

The Modified Frenchay Scale (MFS)

时间窗: 3 weeks

The Modified Frenchay Scale (MFS) measures active upper limb function in hemiparesis based on a video review of 10 everyday living tasks, each rated on a 10-point visual analogic scale. Six tasks are bimanual and four are unimanual performed with the paretic hand. We will measured intra- and inter-rater reliability of MFS in hemiparetic patients among trained raters.

Jebsen Taylor Hand Function Test (JTHFT)

时间窗: 3 weeks

The JTHFT is a common and detailed clinical assessment for fine motor skills with weighted and non-weighted hand functions. The test is derived from activities of daily routine and consists of writing a standardized sentence, turning over 5 cards, picking up and replacing small objects; simulated eating using a spoon and 5 kidney beans, stacking 4 draughts pieces on a board, turning over 5 large empty tins and turning over 5 full tins.

次要结局

  • Sensory Test- Finger Shift Test(3 weeks)
  • Sensory Test- Thumb Localization Test(3 weeks)
  • Goal Attainment Scaling (GAS)(3 weeks)
  • Sensory Test- Stereognosy Test(3 weeks)
  • The Stroke Specific Quality Of Life Scale (SSQOL)(3 weeks)

研究者

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

Muhammed Rohat YAZICI

Researcher Assistant

Kocaeli University

研究点 (1)

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