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临床试验/NCT05385497
NCT05385497已完成不适用

Combining Aerobic Exercise and Virtual Reality for Cognitive-motor Rehabilitation in Parkinson's Disease

The University of Texas Health Science Center at San Antonio2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年11月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Spatiotemporal Parameters

研究概览

简要总结

This project will provide preliminary data on the feasibility and effects of exercise and VR on motor behavior and neuroplasticity in PD. Results from this work will provide insight into whether combination interventions utilizing AE and VR have parallel effects on cognition, gait, and neuroplasticity in PD.

详细描述

In this pilot proof-of-concept study, the study team will recruit 10 individuals with Parkinson's disease who will perform aerobic exercise (AE) followed by virtual reality (VR). The study team will measure the effects of the intervention on dual task performance, clinical measures of gait, cognition, TMS measures and questionnaires pertaining to quality of life.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

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

  • Diagnosis of idiopathic PD (ages 18 - 85) in Hoehn and Yahr stages 1 -
  • Subjects need to demonstrate a score of equal to or greater than 23 on the Mini Mental State Examination.

排除标准

  • Subjects with a history of other neurological diseases (i.e. stroke, multiple sclerosis).
  • Subjects with a history of severe cardiopulmonary disease, uncontrolled hypertension, orthostatic hypotension, uncontrolled diabetes, severe osteoporosis.
  • Subjects with a history of PD-specific surgical procedure such as deep brain stimulation etc.
  • Subjects with a history of head injury.
  • Subjects with a history of seizures or epilepsy,
  • Subjects who are currently pregnant
  • Subjects who use of medications that could alter corticomotor excitability or increase risk of seizure
  • Subjects with skull abnormalities, fractures, unexplained, recurring headaches.
  • Subjects who have cognitive or communication impairment that would affect participation.

结局指标

主要结局

Spatiotemporal Parameters

时间窗: Baseline to 3 weeks

Spatiotemporal measures of gait will be acquired with a gait mat during single and dual task conditions. Participants will perform 2 trials each at their self-selected speed for the single task and dual task conditions for the the gait tests.

Balance

时间窗: Baseline to 3 weeks

Balance will be tested with the Mini-BESTest (Balance Evaluation Systems Test), involving 14 different tasks to assess static and dynamic balance. The Mini-BESTest is a clinical test for the construct of dynamic balance. It consists of 14 items, divided into four subcomponents: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Items are scored from 0 (unable or requiring help) to 2 (normal) on an ordinal scale, with the maximal total score of 28 points. A higher score indicates better balance.

Gait speed

时间窗: Baseline to 3 weeks

10 Meter Walk Test for comfortable and fast gait speed (m/s).

Cognition

时间窗: Baseline to 3 weeks

Parkinson's disease (PD)-cognitive rating scale

Corticomotor excitability

时间窗: Baseline to 3 weeks

Change in Corticomotor excitability as measured with transcranial magnetic stimulation (TMS).

次要结局

  • Quality of Life Survey(Baseline to 3 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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