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临床试验/NCT06615115
NCT06615115招募中不适用

Effects of an External and Combined Focus of Attention-Instructed Exercise Program on Postural Stability and Dual-Task Walking in Parkinson's Disease: A Randomized, Assessor-Blinded, Controlled Trial

Bahçeşehir University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
48
试验地点
2
主要终点
Berg Balance Scale

研究概览

简要总结

Parkinson's disease is the most common progressive neurodegenerative movement disorder. Common movement impairments in Parkinson's include balance and walking difficulties. These impairments lead to falls, increased levels of functional dependency, and a decrease in quality of life. Exercise in Parkinson's patients improves their functional symptoms in daily life, enhancing both motor and non-motor skills, and consequently increases their quality of life. Recently, various additional methods have been developed to increase the effectiveness of exercise in Parkinson's rehabilitation and to contribute to motor skills. Focus of attention instructions are fundamental concepts in motor function learning. External focus of attention has been shown to facilitate motor function development, reduce postural instability, and improve dual-task walking by being easier to remember. In Parkinson's patients who experience freezing phenomena, internal focus of attention instructions enhance walking stability and movement control, thereby reducing the risk of falls. However, there are no studies on the combined focus of attention instructions in Parkinson's patients. This study is designed as a randomized controlled, single-blind, prospective trial to examine the effects of a combination of internal and external focus of attention instructions on walking, balance parameters, quality of life, and patient satisfaction levels, taking into account the presence of freezing phenomena in Parkinson's patients.

详细描述

Parkinson's disease (PD) is the most common progressive neurodegenerative movement disorder. Common movement impairments in Parkinson's include balance and walking difficulties. These impairments lead to falls, increased levels of functional dependency, and a decrease in quality of life. Such deficits are associated with the acquisition of motor function skills. Although PD patients are open to learning, they experience challenges with motor planning. Therefore, individuals with PD may require additional training, sensory input, and motor education for the permanence and ease of motor skill acquisition.

The difficulties PD patients face with complex commands indicate that they can learn in a feedforward manner, but they show inconsistencies in the use of automatic functions. This inconsistency results in challenges in adapting to variable situations and performing complex activities (like balance and walking). Exercise in Parkinson's patients improves their functional symptoms in daily life, enhancing both motor and non-motor skills, and consequently increasing their quality of life. Recently, various additional methods have been developed to enhance the effectiveness of exercise in Parkinson's rehabilitation and to contribute to motor skills. One commonly used method to address deficits in motor behavior is motor learning activities, which involve repetitive movements and ensure continuity.

Many studies have shown that the concept of focus of attention contributes to the efficiency and learning of various motor functions, particularly balance. Individuals with Parkinson's are highly receptive to external stimuli, so a focus-based strategy during balance and walking training can improve these skills. Focus of attention instructions are fundamental concepts in motor function learning. External focus of attention facilitates motor function development, reduces postural instability, and improves dual-task walking. In Parkinson's patients who experience freezing phenomena, internal focus of attention instructions enhance walking stability and movement control, thereby reducing the risk of falls. However, there are no studies on the combined focus of attention instructions in Parkinson's patients.

This study is designed as a randomized controlled, single-blind, prospective trial to examine the effects of a combination of internal and external focus of attention instructions on walking, balance parameters, quality of life, and patient satisfaction levels, considering the presence of freezing phenomena in Parkinson's patients. Approximately 48 individuals with Parkinson's disease without freezing phenomena will participate in an exercise program for six weeks, three days a week. Participants will be randomized into a combined focus group, an external focus group, and a control group. Assessments will be repeated at the beginning and end of the six-week exercise program.

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)

盲法说明

The participant will do the evaluations but no info will be given about the randomization adn groups.

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hoehn and Yahr Stage II or III
  • Individuals between the ages of 50 and 70 who can walk independently but have balance disorders
  • Having a score between 21-56 on the Berg Balance Scale
  • Having a score between 24-30 on the Mini Mental State Test
  • Having agreed to participate in the study (Not having a freezing phenomenon)
  • Being in the Medication-on period

排除标准

  • Having malignancy and metabolic diseases
  • Having had Cerebrovascular Accident before
  • Other neurological disease history
  • Presence of cognitive problems
  • Presence of visual or hearing disorders
  • Presence of deep brain pacemaker
  • Presence of freezing phenomenon (persons with Freezing of Gait Questionnaire FOG-Q above zero)
  • Presence of dyskinesia

结局指标

主要结局

Berg Balance Scale

时间窗: baseline, six weeks after the baseline

This is a 14-item scale that measures the ability to maintain balance during dynamic tasks. It is rated on a scale of 0 to 4 points, with a maximum total score of 56. As the total score decreases, the risk of falling increases. 0 to 20 points: Indicates that the individual is dependent on a wheelchair and has a 100% risk of falling. 21 to 40 points: Suggests that the individual has a moderate risk of falling and may be able to walk with assistance. 41 to 56 points: Indicates that the individual can ambulate independently with a low risk of falling.

Time Up and Go Dual Task

时间窗: baseline, six weeks after the baseline

The test assesses balance, walking, and functionality during activities. The TUG-Dual Task evaluates walking abilities and attention management by asking participants to solve a simple math problem or perform another cognitive task while walking. Patients will be assessed for functionality, walking speeds, and balance evaluations. If the duration lasts more than 12 seconds, there is a risk of falling.

次要结局

  • The Parkinson's Disease Questionnaire-39 (PDQ-39)(baseline, six weeks after the baseline)

研究者

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

Pelin Pişirici

Assistant Professor, PT, PhD

Bahçeşehir University

研究点 (2)

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