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临床试验/NCT05592249
NCT05592249已完成不适用

The Effect of Different Dual Task Practices on Activities of Daily Living in Stroke Individuals

Istanbul University - Cerrahpasa2 个研究点 分布在 2 个国家目标入组 29 人开始时间: 2022年12月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
29
试验地点
2
主要终点
Stroke Impact Scale 3.0

研究概览

简要总结

The aim of this study is to investigate the effectiveness of different dual-task practices on activities of daily living in stroke patients. The sample size was calculated as 18 people for each group and 36 people in total, with a 20% drop out. MC (Motor - Cognitive) group will receive 60 minutes motor - cognitive dual task intervention 5 day per week for 6 weeks in clinic. MM (Motor - Motor) group will receive 60 minutes motor - motor dual task intervention 5 day per week for 6 weeks in clinic. As the primary outcomes in the study; Modified Barthel Index will be used to evaluate basic activities of daily living, Nottingham Extended Activities of Daily Living Index designed specifically for stroke to evaluate instrumental activities of daily living, and Stroke Impact Scale 3.0 to evaluate participation in activities of daily living. As secondary outcomes; 10 Meter Walk Test will be used for functional mobility assessment, Timed Up and Go Test and Berg Balance Scale will be used for balance assessment, Motor Activity Log-28 will be used to assess upper extremity functions, and Montreal Cognitive Assessment Test will be used for cognitive status assessment.

详细描述

Postural control is lost due to decrease in unilateral muscle strength and joint range of motion, and increase in muscle tone in stroke individuals, and accordingly, deterioration in balance and coordination between the two sides of the body is observed. Spasticity, abnormal movement patterns, and loss of motor control are observed in patients, and ambulation limitations occur in patients. In addition, approximately two-thirds of stroke patients have impairments in cognitive skills, which are necessary for the realization of motor skills. Depending on the executive dysfunction, problems also arise in the planning, sequencing, and coordination of actions. Stroke patients have difficulty in doing many activities that they encounter in their daily lives, such as walking and climbing stairs, and as a result, their quality of life and participation in daily life activities are negatively affected. For this reason, approaches aimed at regulating not only muscle tone and strength, but also approaches to ensure participation in daily life activities and increase functionality should be preferred in the rehabilitation process of stroke patients.

Considering the traditional approaches applied in stroke rehabilitation, it is seen that balance and gait training are frequently given to patients. However, in daily life, it may be necessary to use cognitive skills as well as motor activities simultaneously or to perform two motor skills at the same time. Patients have difficulty in performing two tasks at the same time, such as carrying a bag while climbing stairs, calculating while walking, and reading a newspaper while on an exercise bike. In order to increase the participation of stroke patients in daily life, the dual-task approach should be included in the treatment strategies.

Dual task applications are the ability to perform two tasks at the same time, which have different goals and can be evaluated separately, and is a motor learning-based approach. One of the tasks may be a motor task and the other may be a cognitive task, or both may be a motor task. Studies have concluded that dual-task training has positive effects on gait parameters, balance, and cognition, and it has been reported that it is a current approach that can be used in the treatment of stroke patients. However, there is no study comparing the participation of dual tasks, such as one cognitive and one motor task or two motor tasks, in activities of daily living in stroke patients.

When activities of daily living are examined, most of the motor activities are accompanied by actions that include cognitive processes such as attention, memory, problem solving, and concentration. For this reason, in this study, it is assumed that different dual-task approaches to be applied in the rehabilitation of stroke patients will give different results in the participation of individuals in daily life activities and that the application of motor and cognitive tasks together will be more effective than the application of two motor tasks together. In the light of all these, the aim of this study is to investigate the effectiveness of different dual-task practices on activities of daily living in stroke patients.

The hypothesis of this study is;

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
Double (Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • To be diagnosed with stroke by a specialist physician
  • Modified Rankin Score ≤ 3 with moderate or mild disability
  • To score 21 and above on the Montreal Cognitive Assessment Test
  • Be over 18 years old
  • Volunteering to participate in the study

排除标准

  • Presence of additional neurological disease
  • Having orthopedic problems that may prevent walking
  • Presence of apraxia
  • The patient has a hearing loss that cannot understand the commands given
  • To have a score below 30 on the Beck Depression Scale

研究组 & 干预措施

Motor - Cognitive

Experimental

Motor - Cognitive group will receive motor and cognitive dual task intervention.

干预措施: Dual Task MC (Other)

Motor - Motor

Experimental

Motor - Motor group will receive motor and motor dual task intervention.

干预措施: Dual Task MM (Other)

结局指标

主要结局

Stroke Impact Scale 3.0

时间窗: 6 weeks

The Stroke Impact Scale (SIS) 3.0 aims to evaluate the quality of life of patients after stroke, consists of 8 subsections and a total of 59 questions. It evaluates muscle strength, hand functions, activities of daily living, mobility, communication skills, mood, memory and participation of patients after stroke. Each question is scored by evaluating on a 5-point Likert-type scale. 1 point means not being able to perform the function asked at all, while 5 points means not having any difficulties. In addition to 8 sub-sections, there is a visual analog scale that is scored between 0-100 at the end of the scale and the perception of recovery after stroke is evaluated. A score of 0 on this scale is "No improvement at all." A score of 100 means "Complete recovery". The maximum score that can be obtained is 395, and the minimum score is 59. An increase in the total score in SIS indicates the independence of the patient in activities of daily living while a decrease indicates dependence.

Nottingham Extended Activities of Daily Living Index

时间窗: 6 weeks

The Nottingham Extended Activities of Daily Living Index is a scale designed specifically for stroke and evaluated by self-report. This scale, which aims to measure the quality of daily life of individuals in instrumental activities based on performance, consists of 4 subgroups as movement, kitchen, housework and leisure activities and a total of 22 items. Each question evaluates the difficulty of the activity on a 4-point Likert scale. 0 points means "I can't do it at all." 3 points means "I do it easily by myself.". The maximum score that can be obtained from the scale is 66. An increase in the score indicates independence in the instrumental activities of daily living.

Modified Barthel Index

时间窗: 6 weeks

The Modified Barthel Index (MBI) is a scale created to evaluate functional independence. The scale evaluates the functional independence level of the person in 10 activities, including transfer, ambulation, stairs, feeding, dressing, personal care, bathroom, toilet use, and urine and stool continence. Each question is answered in 5 different levels. Level 1 means "The individual is inadequate to do the activity." while Level 5 means "Completely independent.". The score that the patient can get is between 0-100. The higher the score, the higher the person's level of functional independence.

次要结局

  • Timed Up and Go Test(6 weeks)
  • Motor Activity Log - 28(6 weeks)
  • 10 Meter Walk Test(6 weeks)
  • Berg Balance Scale(6 weeks)
  • Montreal Cognitive Assessment Test(6 weeks)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse Zengin Alpozgen

Asst. Prof. (PhD)

Istanbul University - Cerrahpasa

研究点 (2)

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