跳至主要内容
临床试验/NCT06418152
NCT06418152已完成不适用

Dual-task Augmented Reality Treatment (DART) for Parkinson's Disease and Deep Brain Stimulation

Jay Alberts2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2024年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
7
试验地点
2
主要终点
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score

研究概览

简要总结

The goal of this project is to evaluate the safety and preliminary effectiveness of utilizing a digital therapeutic, Dual-task Augmented Reality Treatment (DART) protocol, for the treatment of postural instability and gait dysfunction (PIGD) in individuals with PD with a previously implanted deep brain stimulator (DBS).

详细描述

Multi-Modal Training in PD patients: In order to treat dual-task impairment (difficulty performing two tasks at once), multi-modal treatment (MMT) was designed to target PD-specific declines in the areas of cognitive function and gait and posture impairments. Briefly, MMT training consists of simultaneously training a motor and cognitive task. The motor aspect of MMT stresses high velocity, high amplitude training principles while the cognitive aspect stresses commonly impaired cognitive domains in PD such as attention and executive function. An example of an MMT task is marching while spelling words backwards.

Delivery of a Digital Therapeutic via Augmented Reality for the Treatment of PIGD: The MMT intervention is well-suited for integration into an augmented reality (AR) platform as it consists of the patient performing a series of cognitive and motor tasks simultaneously while the patient receives knowledge of performance and results from a therapist. The Microsoft HoloLens is an untethered, AR headset used in applications as broad as teaching anatomy, displaying fine art and gaming. With AR, the user maintains contact with the physical world and the people in it. The HoloLens uses AR technology to place holograms, objects made entirely of projected light, into the user's physical environment; hence creating a first-person mixed reality environment. These holograms can be viewed from different angles and distances, can be two-dimensional or three-dimensional, can appear life-like, can move, be shaped, and change according to interaction with users' or the physical environment in which they are projected, depending on the programming. The MMT was previously developed for the Dual-task Augmented Reality Treatment (DART), which delivers MMT training on a head-mounted AR display. The DART platform was successfully piloted in 50 individuals with PD who did not have DBS (IRB # 20-207). The results of the project indicate that DART is an effective method of training for individuals with PD. The goal is to expand the impact of that project through the investigation of DART in individuals with PD who have previously undergone DBS surgery.

研究设计

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

入排标准

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

入选标准

  • Adult with a diagnosis of idiopathic PD
  • History of deep brain stimulator placement for treatment of PD
  • Ability to ambulate > 10 minutes continuously without an assistive device

排除标准

  • Medical diagnosis of dementia or any neurocognitive impairment that compromises the ability to provide informed consent
  • >2 errors on the Short Portable Mental Status Questionnaire
  • Musculoskeletal or cardiopulmonary issue that limits one's ability to engage in exercise
  • Neurological disease other than Parkinson's disease that impacts motor or cognitive function

结局指标

主要结局

Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score

时间窗: Baseline and through study completion, average 8 weeks

Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination score, measured off medication. Range of scores is 0 to 132, with lower score indicating better motor function. Change in MDS-UPDRS III score from baseline through completion.

次要结局

  • Two Minute Walk Test(Baseline and through study completion, average 8 weeks)
  • Two Minute Walk Test(Baseline and through study completion, average 8 weeks)

研究者

发起方
Jay Alberts
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jay Alberts

Center Director

The Cleveland Clinic

研究点 (2)

Loading locations...

相似试验

Dual-task Augmented Reality for PD DBS | 临床试验