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临床试验/NCT07322939
NCT07322939招募中不适用

Effects of Visual Indicator Exercises for the Trunk and Lower Extremities on Activity and Participation in Parkinson's Disease

Hasan Kalyoncu University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
32
试验地点
1
主要终点
Center of Pressure Elliptical Area

研究概览

简要总结

Patients with Parkinson's disease who apply to the Hasan Kalyoncu University Application and Research Center and meet the inclusion criteria will be included in the study. The included participants will be randomly assigned into either the intervention group or the control group using a sealed-envelope method. Both groups will undergo a standard exercise program, consisting of posture, strengthening, and balance training, under the supervision of a physiotherapist for 8 weeks, 3 days per week. In addition to this, the intervention group will receive an additional exercise program incorporating visual feedback using a laser pointer, targeting the trunk and lower extremities, also under the supervision of a physiotherapist for 8 weeks, 3 days per week.

详细描述

This study aims to investigate the effects of visual feedback exercise training focused on balance, postural control, and lower extremity mobility using a laser pointer, in addition to standard rehabilitation, on activity and participation in individuals with Parkinson's disease.

Hypotheses:

H1: Incorporating visual feedback-based trunk and lower extremity exercises using a laser pointer into standard rehabilitation improves body structure and function in individuals with Parkinson's disease.

H2: Incorporating visual feedback-based trunk and lower extremity exercises using a laser pointer into standard rehabilitation enhances activity and participation in individuals with Parkinson's disease.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals diagnosed with idiopathic Parkinson's disease
  • Disease severity classified as stage 1 to 3 according to the Modified Hoehn and Yahr Scale
  • Patients receiving oral antiparkinsonian treatment only
  • Exclusion Critera
  • Presence of musculoskeletal, cardiovascular, or vestibular disorders that may interfere with the completion of the assessments or treatment protocol
  • Presence of additional neurological or psychiatric disorders other than Parkinson's disease
  • Presence of visual impairment insufficient to perceive visual feedback

排除标准

  • 未提供

研究组 & 干预措施

standard exercise program

Active Comparator

Participants in the standard exercise group will receive a physiotherapist-supervised exercise program, performed three times per week for a total duration of eight weeks.

干预措施: Control Group (Other)

standard exercise program and visual feedback-based exercise program

Experimental

Participants in the standard exercise program and visual feedback-based exercise program group will receive a physiotherapist-supervised exercise program, performed three times per week for eight weeks.

干预措施: Control Group (Other)

standard exercise program and visual feedback-based exercise program

Experimental

Participants in the standard exercise program and visual feedback-based exercise program group will receive a physiotherapist-supervised exercise program, performed three times per week for eight weeks.

干预措施: Visual Feedback Exercise Group (Other)

结局指标

主要结局

Center of Pressure Elliptical Area

时间窗: up to 8 weeks

Postural control will be assessed using the Gyko wearable device. After the wearable vest is properly fitted, the participant will be asked to maintain balance for 30 seconds under four conditions: firm surface with eyes open, firm surface with eyes closed, soft surface with eyes open, and soft surface with eyes closed. The elliptical area of center of pressure displacement (mm²) obtained from the Gyko system will be recorded for each condition and used as the primary outcome measure.

Berg Balance Scale

时间窗: up to 8 weeks

The Berg Balance Scale is used to assess functional balance. It evaluates both dynamic and static balance through 14 tasks related to different positions, postural changes, and mobility. Each task is scored between 0 and 4 based on the individual's ability to perform the task independently, for a certain period, or over a specific distance (0: unable to perform, 4: normal performance). The highest possible score on the scale is 56, and a higher score indicates greater independence.

次要结局

  • L Test(up to 8 weeks)
  • Unified Parkinson's Disease Rating Scale(up to 8 weeks)
  • New York Postural Assessment Test(up to 8 weeks)
  • Visual Analog Scale(up to 8 weeks)
  • Parkinson Fatigue Scale(up to 8 weeks)
  • 10-Meter Walk Test(up to 8 weeks)
  • Activities-specific Balance Confidence Scale(up to 8 weeks)
  • Functional Reach Test(up to 8 weeks)
  • Five Times Sit-to-Stand Test(up to 8 weeks)
  • Freezing of Gait Questionnaire(up to 8 weeks)
  • Parkinson's Disease Quality of Life Questionnaire (PDQ-39)(up to 8 weeks)

研究者

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

Büşra Akıncı

Principal Investigator

Hasan Kalyoncu University

研究点 (1)

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