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临床试验/NCT07250672
NCT07250672招募中不适用

Examining the Effect of Action Observation Training Using Patient-Specific 3D Records in Parkinson's Patients

Abant Izzet Baysal University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年12月15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
入组人数
24
试验地点
1
主要终点
Spontaneous Movement Rate (SMR

研究概览

简要总结

Although studies exist demonstrating the effects of single-session action observation training on bradykinesia in patients with Parkinson's disease, research investigating the long-term application of such training remains limited. Furthermore, the broader literature indicates that action observation training has typically been conducted in simulated environments or by using recordings obtained from healthy individuals. The aim of the present study is to examine the effects of action observation training, delivered in a fully immersive virtual reality environment using each patient's own 3D motion recordings, on bradykinesia and other disease-related parameters.

详细描述

Action observation training has been applied across diverse populations to improve performance and treat pathological conditions. Considering that bradykinesia tends to manifest more prominently in rhythmic movements, studies in healthy individuals have shown that merely observing rhythmic actions can influence spontaneous finger movement speed and lead to changes in motor performance, thereby paving the way for the use of action observation in addressing bradykinesia. In a study investigating the effects of action observation in patients with Parkinson's disease, observing fast rhythmic finger movements was reported to increase spontaneous finger movement speed, and compared with acoustic training, the effect of action observation persisted longer over time. Research on imagery through action observation further indicates that immersive virtual reality headsets, compared to monitor screens, facilitate the development of more distinct spatial rhythmic patterns in the brain. This evidence supports the use of fully immersive VR headsets instead of non-immersive monitor-based systems in action observation training.

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

Only the outcome assessor will be masked to group allocation.

入排标准

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

入选标准

  • •Voluntary agreement to participate in the study
  • •Clinical diagnosis of Parkinson's disease confirmed by a neurologist
  • •Ongoing treatment with antiparkinsonian medication
  • •Hoehn and Yahr (H-Y) stage ≤ 3
  • •Ability to walk independently

排除标准

  • •Presence of additional neurological disorders other than Parkinson's disease
  • •Change in medication dosage within the past month
  • •Score of ≥ 10 on the Simulator Sickness Questionnaire
  • •Presence of amblyopia, strabismus, or pathologies impairing focus, depth perception, or normal 3D vision
  • •Failure on the butterfly test of the Titmus stereotest (greater than 3,552 seconds of arc)

研究组 & 干预措施

Patient-Specific VR Group

Experimental

Participants will undergo action observation training delivered in immersive virtual reality using their own 3D motion recordings.

干预措施: Patient-Specific VR Action Observation Training (Other)

Healthy-Model VR Group

Active Comparator

Participants will undergo action observation training delivered in immersive virtual reality using 3D recordings obtained from healthy individuals performing the same actions.

干预措施: Healthy-Model VR Action Observation Training (Other)

结局指标

主要结局

Spontaneous Movement Rate (SMR

时间窗: At baseline and after completion of 6-week intervention period

In this study, kinematic parameters of finger movements will be determined from video recordings. A commercial motion analysis software will be used to extract the coordinates of manually marked tracking points, which will then be transferred into tabular form for analysis. To improve the accuracy of marking and tracking, participants will wear fingertip gloves in different colors.The spontaneous movement rate will be calculated from video-recorded finger-tapping tasks. Each cycle consists of a touch duration (TD) and an inter-tapping interval (ITI). SMR will be defined as the inverse of the total duration of one tapping cycle (TD + ITI) and expressed in Hertz (Hz).

次要结局

  • Unified Parkinson's Disease Rating Scale (UPDRS)(At baseline and after completion of 6-week intervention period)
  • Nine-Hole Peg Test (NHPT)(At baseline and after completion of 6-week intervention period)
  • Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH)(At baseline and after completion of 6-week intervention period)
  • Parkinson's Disease Questionnaire (PDQ-8)(At baseline and after completion of 6-week intervention period)
  • Intrinsic Motivation Inventory (IMI)(After completion of 6-week intervention period)

研究者

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

enes tayyip benli

Assistant Professor

Abant Izzet Baysal University

研究点 (1)

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