跳至主要内容
临床试验/NCT07212205
NCT07212205已完成不适用

The Effect of Visual and Auditory Cueing Walker on Gait in Individuals With Parkinson's Disease Experiencing Freezing of Gait

Necmettin Erbakan University4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年6月10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
入组人数
30
试验地点
4
主要终点
Gait Adaptation

研究概览

简要总结

The aim of this study was to investigate the effects of a visual and auditory cueing walker on freezing of gait during walking in patients with Parkinson's disease (PDF), compared to Parkinson patients without freezing of gait (PDNF).Sample size was calculated to detect a difference of 0.37 m/sec on mean velocity, with a deviation of 0.3 m/sec, two-sided 5% significance level, and power of 90%. Considering the expected 10% dropout rate, twelve subjects were included.Researcher R1 determined whether the subject was eligible for inclusion in the trial and researcher R2 carried out the gait analysis. Both examiners were unaware of group allocation. An independent researcher (R3) performed the clinical evaluation before the procedures started. Participants walked back and forth on a 7-meter walking path under two different conditions: without cues and with a walker providing visual and auditory cues. To assess the risk of falls in both groups, the "Tinetti Balance and Gait Assessment" was conducted. Additionally, the "Dynamic Gait Index" was used to evaluate the ability to adapt walking to varying task demands, and the Timed Up and Go Test (TUGT) was employed to determine walking speed.

详细描述

This study suggests that a walker providing visual and auditory cues may improve daily walking in patients with Parkinson's disease with freezing of gait (PDF) and reduce the risk of falls in patients with Parkinson's disease without freezing of gait (PDNF) who exhibit hypokinetic gait patterns.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Those with a Hoehn-Yahr classification between 2.5 and 4 were included in the study.

排除标准

  • •Patients with secondary parkinsonism, severe systemic diseases, psychiatric illness, cognitive impairment (Mini-Mental State Examination score <24), hearing and vision loss, musculoskeletal problems, or symptoms suggestive of cerebellar dysfunction were excluded from the study.

研究组 & 干预措施

PDF (Parkinson's Disease with Freezing of Gait)

Experimental

Intervention Name: Visual & Auditory Cueing Walker

Description:

"Participants in this arm were assessed under two within-subject conditions: walking on a 7-meter path without cues (control condition) and walking on the same path using a visual and auditory cueing walker (intervention condition). Each participant completed both conditions in a single session. Pre- and post-walking evaluations were conducted for walking speed (Timed Up and Go Test), fall risk (Tinetti Balance and Gait Assessment), and gait adaptation (Dynamic Gait Index). The 'no cues' condition represents a repeated-measures control within the same arm. Participants were included based on the presence of freezing of gait."

Planned Enrollment: 18

干预措施: Visual & Auditory Cueing Walker (Other)

PDNF (Parkinson's Disease without Freezing of Gait)

Experimental

Intervention Name: Visual & Auditory Cueing Walker

Description:

"Participants in this arm were assessed under two within-subject conditions: walking on a 7-meter path without cues (control condition) and walking on the same path using a visual and auditory cueing walker (intervention condition). Each participant completed both conditions in a single session. Pre- and post-walking evaluations were conducted for walking speed (Timed Up and Go Test), fall risk (Tinetti Balance and Gait Assessment), and gait adaptation (Dynamic Gait Index). The 'no cues' condition represents a repeated-measures control within the same arm. Participants were included based on the absence of freezing of gait."

Planned Enrollment: 12

干预措施: Visual & Auditory Cueing Walker (Other)

结局指标

主要结局

Gait Adaptation

时间窗: Immediately after walking with the visual and auditory cueing walker test was completed

Dynamic Gait Index: Time taken by the participant to complete the 7-meter walking path under each condition (without cues and with visual \& auditory cueing walker), measured using the Timed Up and Go Test (TUGT).

次要结局

未报告次要终点

研究者

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

Neslihan Altuntas Yilmaz

Asst. Prof.

Necmettin Erbakan University

研究点 (4)

Loading locations...

相似试验