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临床试验/NCT06317792
NCT06317792尚未招募不适用

Assessing the Efficacy of Online Exergaming-Integrated Physiotherapy for Parkinson's Disease: A Validation Study

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4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
尚未招募
发起方
入组人数
50
试验地点
2
主要终点
Unified Parkinson's Disease Rating Scale score assessment

研究概览

简要总结

To validate the efficiency of online exergaming-based physiotherapy. We will enroll patients with Parkinson's disease in postural instability and gait disturbance motor phenotype in the study and divide them into two groups in a randomized controlled study.

详细描述

The investigators will enroll patients in PIGD and divide them into two groups in a randomized controlled study. Participants received an exergaming intervention using the Kinect sensor (Microsoft Corporation, Redmond, WA, USA) from a commercially available exercise system (HappyGoGo, LONGGOOD MEDITECH LTD., Taipei, Taiwan). The Kinect sensor incorporates infrared light and a video camera, which creates a 3D map of the area in front of it. This device provides full-body 3D motion capture.

The online exergaming-based physiotherapy programs focus on training in shoulder, hip, and knee ROM balance, weight-bearing, strength, weight shifting, and walking based on RF in machine learning to the features selection in patients with PIGD. The training tasks consist of 10 pieces of training (20 minutes per session, five sessions every week, for 8 weeks). Five exergaming programs were used for training, designed to incorporate an appropriate level of challenge to match the ability and fitness of patients with PD.

To confirm the status of individual training at home, the data will be sent back to the computer output report of the medical side after each training is completed. These data include the quantitative data of a joint ROM, the movement cycle change diagram, and the upper and low limb movements decomposed by each movement plane. The investigators also obtain the trajectory path mapping to understand whether the quality of individual actions is accurate, in place, and line with expected benchmarks.

Safety and Tolerability: If the patient can not complete half of the rehabilitation program, this/her data will be excluded from the analysis.

Exergame rehabilitation outcome assessments To evaluate the efficiency and the durability of the training effect. Outcomes were measured at five different periods including Month 0 (pretest) (clinical score, gait cycle, cognitive function, and fMRI), Month 2 (posttest) (clinical score, gait cycle, and fMRI), and Month 8 (follow-up) (clinical score, gait cycle, and cognitive function) and Year 2 and year 3 (follow-up) (clinical score, gait cycle, and cognitive function).

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1. Clinical diagnosis of Parkinson's disease

排除标准

  • Moderate and severe dementia (Clinical Dementia Rating more than or equal to 2)
  • Advanced PD stage (Hoehn and Yahr staging equal or more than four)

研究组 & 干预措施

Online exergaming-based physiotherapy intervention group

Experimental

The training tasks consist of a set of 10 pieces of training (20 min per session, five sessions every week, for 8 weeks)

干预措施: online exergaming-based physiotherapy programs (Other)

Online exergaming-based physiotherapy observation group

No Intervention

Observation only

结局指标

主要结局

Unified Parkinson's Disease Rating Scale score assessment

时间窗: Intervention and follow-up period through study completion, an average of 3 years

The outcome measure is the Unified Parkinson's Disease Rating Scale score. The UPDRS scale consists of the following six segments: 1) Mentation, Behavior, and Mood, 2) ADL, 3) Motor sections, and 4) Complications of Therapy (in the past week) The four segments are made up of 42 items grouped into four subscales. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe)

Tinetti balance and gait score assessment

时间窗: Intervention and follow-up period through study completion, an average of 3 years

The score consists of two parts, including the balance score (score=0-16) and gait score (score=0-12), and ranged from 0 to 28 points by summing the points obtained for each of the two tests.

次要结局

  • Fall Risk assessment using Berg Balance Scale(intervention and follow-up period through study completion, an average of 3 years)
  • Depression severity assessment(intervention and follow-up period through study completion, an average of 3 years)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cheng-Hsien Lu, MD, MSc

Professor of neurology

Chang Gung Memorial Hospital

研究点 (2)

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