Motor-Cognitive Training for Motoric Cognitive Risk Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Dual-task gait speed
研究概览
简要总结
The goal of this clinical trial is to investigate if combined motor-cognitive training can improve motor and cognitive symptoms in older adults with motoric cognitive risk syndrome. The main questions it aims to answer are:
- Does motor-cognitive training using a virtual reality treadmill improve gait speed?
- Does motor-cognitive training using a virtual reality treadmill improve cognitive functions?
Researchers will compare virtual reality treadmill training with treadmill training to see if virtual reality treadmill training works to improve motor and cognitive functions in older adults at risk of dementia
Participants will
- Complete 18 sessions (1 hour, 3x/week, 6 weeks) of either virtual reality treadmill training or treadmill training
- Complete a pre- and post-training assessment
- Wear an activity sensor for seven days prior to the pre-training assessment and for seven days after the post-training assessment.
详细描述
The objective of this single-blind randomized controlled trial is to compare the effects of combined motor-cognitive training using a virtual reality treadmill with motor training using a conventional treadmill in older adults with Motoric Cognitive Risk (MCR) syndrome. MCR is a geriatric condition characterized by slow gait speed and subjective cognitive complaints. The coexistence of motor and cognitive impairments in individuals with MCR significantly increases their risk of developing dementia. To date, randomized controlled trials investigating active interventions that simultaneously target both motor and cognitive functions remain scarce. This study will examine whether 18 training sessions, delivered over six weeks at a frequency of three 1-hour sessions per week, using a virtual reality treadmill lead to greater improvements in motor and cognitive outcomes compared to conventional treadmill training.
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
Assessors will be blinded to the group allocation
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English speaking
- •Normal cognition (CDR=0)
- •Meet MCR criteria
- •Voluntary consent
排除标准
- •Major chronic unstable disease or neurological condition (e.g., seizures)
- •Diagnosed dementia
- •Active psychiatric conditions
- •Musculoskeletal conditions that affect walking for more than 2 minutes
- •Severe visual or hearing impairments
- •Sedating drugs (new use of narcotics or anxiolytics within the past month or chronic use that causes sedation)
- •Currently engaged in other non-pharmacological interventions to improve cognition or walking
研究组 & 干预措施
Virtual Reality Treadmill Training
The virtual reality treadmill training (VRTT) group will complete 18 training sessions over six weeks (three 1-hour sessions per week). Participants will perform prescribed tasks designed to challenge motor, cognitive, and motor-cognitive functions within a VR environment projected onto a screen in front of the treadmill (Fig 1). The VRTT system includes a conventional treadmill with a harness suspension system, camera-based motion capture (Intel RealSense, Santa Clara, CA), and a computer-generated simulation (GaitBetter, Tel Aviv, Israel). The camera tracks the participant's feet movements, which are displayed within the VR environment, allowing participants to see their feet navigating obstacles, pathways, and narrow corridors. Each session will include three walking bouts interspersed with rest breaks, targeting at least 40 minutes of active motor-cognitive training.
干预措施: Virtual Reality Treadmill Training (Behavioral)
Treadmill Training
Participants in the treadmill training (TT) intervention will follow a traditional TT program without feedback from the VR system. 70 The focus will be on increasing gait speed and distance, with no motor-cognitive training such as obstacle crossing or cognitive tasks while walking.
干预措施: Treadmill Training (Behavioral)
结局指标
主要结局
Dual-task gait speed
时间窗: From enrollment to the end of treatment at 6 weeks
2 trials of 2-minute walking on a 10-meter walkway while completing auditory oddball task
Cognition
时间窗: From enrollment to the end of treatment at 6 weeks
Uniform Data Set (UDS) 4.0 global cognition composite score
Gait speed
时间窗: From enrollment to the end of treatment at 6 weeks
Gait speed on 4-meter walk test (4MWT)
Cognitive complaints
时间窗: From enrollment to the end of treatment at 6 weeks
Self-report of cognitive complaints based on memory item of the Geriatric Depression Scale (GDS): yes - no
次要结局
- Spatiotemporal gait characteristics(From enrollment to the end of treatment at 6 weeks)
- Cognitive domain scores(From enrollment to the end of treatment at 6 weeks)
- P3 event-related potential (ERP)(From enrollment to the end of treatment at 6 weeks)
- Mitochondrial function(From enrollment to the end of treatment at 6 weeks)
- Mitochondrial function(From enrollment to the end of treatment at 6 weeks)
- Dual task cost(From enrollment to the end of treatment at 6 weeks)
- Spatiotemporal gait characteristics(From enrollment to the end of treatment at 6 weeks)
- Cognitive domain scores(From enrollment to the end of treatment at 6 weeks)
- P3 event-related potential (ERP)(From enrollment to the end of treatment at 6 weeks)