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临床试验/NCT04115683
NCT04115683Unknown不适用

Effect of Dual Task Training on Balance, Gait, Cognition and Neurotrophic Factors in Parkinson's Disease

Gazi University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年10月16日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
2
主要终点
Balance-Postural Stability

研究概览

简要总结

The aim of study is to analyze the effects of dual task training on balance, gait, cognition and neurotrophic factors in Parkinson's disease.

详细描述

20 patients diagnosed with Parkinson's disease will be randomly assigned to either intervention or control group. And 10 healty subjects will be included to study in order to determine the reference values.The intervention group will be recieved cognitive and motor dual task training consisting of balance and walking activities 3 days a week for 8 weeks. Control group will be recieved same balance and walking activities in single task condition 3 days a week for 8 weeks. In order to evaluate the effects of the training, evaluations will be performed before and after the training period.

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 (Participant)

入排标准

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

入选标准

  • at least 40 years of age
  • neurologist-diagnosed Parkinson's Disease
  • Hoehn & Yahr (H&Y) stages 1 to 3
  • 24 or more mini mental status examination score.

排除标准

  • other neurologic disorder
  • cardiovascular, inflammatory,vestibular or musculoskeletal problems that could prevent them to participate in an exercise program
  • had deep brain stimulation history
  • visual, auditory, orientational problems that could affect study results

结局指标

主要结局

Balance-Postural Stability

时间窗: 8 weeks

Postural Stability will be evaluated with Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York).. Postural Stability test will performed on both feet and on the left and right foot separately. Total stability index score will obtained as the test result.

Montreal Cognitive Assessment (MoCA)

时间窗: 8 weeks

Montreal Cognitive Assessment (MoCA) will be used in order to evaluate cognition. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.It' score ranged from 0 to 30 and higher points indicates better cognitive outcomes.

Balance- Limits of Stability

时间窗: 8 weeks

Limits of Stability will be evaluated with Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York). Limits of Stability test assesses how much the center of gravity is displaced on the support surface without losing balance during the standing position. Total direction control score will obtained as the test result.

Balance- Modified Sensory Organization Tests

时间窗: 8 weeks

Modified Sensory Organization Tests will be evaluated Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York). MSOT assesses the effects of somatosensory, visual and vestibular senses on postural control during the standing position. It evaluates the sensory component of balance in two different visual conditions and on two different support surfaces; condition 1: eyes open-firm surface, condition 2: eyes closed-firm surface, condition 3: eyes open-foam surface and condition 4: eyes closed-foam surface. Stability index scores will obtained as the test result.

Gait Speed

时间窗: 8 weeks

Gait speed will be evaluated by using the BTS-G Walk system and recorded as m/min. It is a wireless system positioned on L5 vertebrae of the spine. It allows a functional objective gait analysis to be performed.

Cadence

时间窗: 8 weeks

Cadence will be evaluated by using the BTS-G Walk system and recorded as strides/min. It is a wireless system positioned on L5 vertebrae of the spine. It allows a functional objective gait analysis to be performed.

Stride width

时间窗: 8 weeks

Stride width will be evaluated by using the BTS-G Walk system and recorded as meters. It is a wireless system positioned on L5 vertebrae of the spine. It allows a functional objective gait analysis to be performed.

Stride length

时间窗: 8 weeks

Stride length will be evaluated by using the BTS-G Walk system and recorded as meters. It is a wireless system positioned on L5 vertebrae of the spine. It allows a functional objective gait analysis to be performed.

Change in insulin like growth factor 1 (IGF-1) levels of serum

时间窗: 8 weeks

Insulin like growth factor 1 (IGF-1) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.

Change in brain derived neurotrophic factor (BDNF) levels of serum

时间窗: 8 weeks

Brain derived neurotrophic factor (BDNF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.

Change in vascular endothelial growth factor (VEGF) levels of serum

时间窗: 8 weeks

Vascular endothelial growth factor (VEGF) levels of serum will be measured by using sandwich enzyme-linked immunosorbent assay (ELISA) kit.

次要结局

  • Stroop Test(8 weeks)
  • One-legged Stance Test(8 weeks)
  • Timed Up and Go (TUG) test(8 weeks)
  • Activities-Specific Balance Confidence (ABC) Scale(8 weeks)
  • Trail Making Test (TMT) Part A and B(8 weeks)
  • Unified Parkinson's Disease Rating Scale (UPDRS)(8 weeks)
  • Berg Balance Scale (BBS)(8 weeks)
  • Short-Form 8-Item Parkinson's Disease Questionnaire (PDQ-8)(8 weeks)
  • Hoehn and Yahr Scale for level of physical disability in Parkinson's disease.(8 weeks)

研究者

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

Çağrı Gülşen

Principal Investigator

Gazi University

研究点 (2)

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