Evaluating the Effects of a Treadmill Gait Training Protocol in a Gamified Virtual Reality Environment With tDCS in Parkinson's Disease: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Step cadence
研究概览
简要总结
The study aims to compare the effects of treadmill gait training in a gamified virtual reality environment with tDCS versus treadmill gait training in a gamified virtual reality environment versus treadmill training in people with Parkinson's Disease.
详细描述
Treadmill gait training has been stablished as a solid gait rehabilitation option for people with Parkinson's Disease. However, gait training by itself fails to address the cognitive aspect needed for safe walking, which could be affected by situations in which concurrent tasks must be managed simultaneously to gait. It also lacks motivational aspects key to keep people with Parkinson's Disease adhered to treatment. Virtual reality and gamification are posed as useful tools to address both these issues, turning training into a more engaging activity and allowing complicated gait situations to be trained in a safe environment. Transcranial direct current stimulation (tDCS) could be combined with these mentioned treatment options, which could reinforce the learning of motor and cognitive skills during training.
The aim of this study is to evaluate the effects of the inclusion of a gamified virtual reality environment to a treadmill gait training program with tDCS in PD compared to the same training protocol with virtual reality and without it
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
The outcome measuring assessors will not know from which group any of the participants comes from, and will have no interaction with any of the interventions applied.
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's Disease
- •Stage II - III in the Hoehn and Yahr Scale during ON state
- •Ability to walk for 10 minutes independently without stop
排除标准
- •Significant cognitive decline based on mini mental status examination (MMSE <23)
- •Severe auditory or visual deficits
- •Other neurological/psychiatric conditions
- •Any kind of cardiovascular complications that contraindicates physical activity
- •Clinical history of any brain surgery or deep brain stimulation device
结局指标
主要结局
Step cadence
时间窗: 14 weeks
Step cadence will be recorded while walking on a 10-meter aisle with an inertial sensor system while the patient is asked to walk at preferred, very slow, slow, medium, high and very high speed. Will be measured in Hertz (Hz).
Stride Length during Dual Task
时间窗: 14 weeks
Stride length will be recorded while walking on a 10-meter aisle with an inertial sensor system while listening to an audio recording, in which patients will hear certain set words and will have to remember how many times they are mentioned (Phoneme Monitoring Paradigm Dual Task). Participants will be asked to walk at preferred speed. Will be measured in meters (m).
Step cadence during Dual Task
时间窗: 14 weeks
Step cadence will be recorded while walking on a 10-meter aisle with an inertial sensor system while listening to an audio recording, in which patients will hear certain set words and will have to remember how many times they are mentioned (Phoneme Monitoring Paradigm Dual Task). Participants will be asked to walk at preferred speed. Will be measured in Hertz (Hz).
Stride Length Variation Coeficient
时间窗: 14 weeks
Based on standard deviation and mean values of Stride Length data, a new variable will be calculated to assess the variability of stride length in participants' gait. Formula will be the following: (Standard deviation/mean Stride Length)100
Step Cadence Variation Coeficient during Dual Task
时间窗: 14 weeks
Based on standard deviation and mean values of step cadence data during Dual Task, a new variable will be calculated to assess the variability of step cadence in participants' gait. Formula will be the following (data from Dual Task variable): (Standard deviation/mean Step Cadence)100
Speed
时间窗: 14 weeks
Speed will be recorded while walking on a 10-meter aisle with an inertial sensor system while the patient is asked to walk at preferred, very slow, slow, medium, high and very high speed. Will be measured in meters per second (m/s).
Speed during Dual Task
时间窗: 14 weeks
Speed will be recorded while walking on a 10-meter aisle with an inertial sensor system while listening to an audio recording, in which patients will hear certain set words and will have to remember how many times they are mentioned (Phoneme Monitoring Paradigm Dual Task). Participants will be asked to walk at preferred speed. Will be measured in meters per second (m/s).
Stride Length Variation Coeficient during Dual Task
时间窗: 14 weeks
Based on standard deviation and mean values of Stride Length data, a new variable will be calculated to assess the variability of stride length in participants' gait. Formula will be the following (data from Dual Task variable): (Standard deviation/mean Stride Length)100
Step Cadence Variation Coeficient
时间窗: 14 weeks
Based on standard deviation and mean values of step cadence data during Dual Task, a new variable will be calculated to assess the variability of step cadence in participants' gait. Formula will be the following: (Standard deviation/mean Step Cadence)100
Stride lenght
时间窗: 14 weeks
Stride length will be recorded while walking on a 10-meter aisle with an inertial sensor system while the patient is asked to walk at preferred, very slow, slow, medium, high and very high speed. Will be measured in meters (m).
次要结局
- Montreal Cognitive Assessment(14 weeks)
- MiniBest Test(14 weeks)
- Unified Parkinson's Disease Rating Scale (UPDRS)(14 weeks)
- Total Cognitive Performance(14 weeks)
- Hoehn & Yahr(14 weeks)
- Parkinson's Disease Questionnaire 39(14 weeks)
研究者
Helena Fernández-Lago
Lecturer
Universitat de Lleida