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临床试验/NCT04415775
NCT04415775Unknown不适用

Changes in Metabolic Activity, and Gait Function by Dual-task Cognitive Game-based Treadmill Intervention in Parkinson's Disease

University of Manitoba1 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2021年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
67
试验地点
1
主要终点
NDWP scores

研究概览

简要总结

The present proposal will evaluate the neural underpinnings of (a) the decline of mobility function in Parkinson's disease (PD), and (b) the effects of an innovative computer-guided dual-task (DT) mobility training platform (complementary approach: exercise intervention). Improved mobility functioning in PD, specifically balance, gait and cognition, directly translates to improved community ambulation as well as increased physical activity and social participation. These benefits are known to have a significant preventive and disease-modifying impact that surpasses any currently available pharmacological interventions. Outcomes of this research will provide new insights into brain plasticity mechanisms and will accelerate further optimization and commercialization of multi-modal mobility-cognitive training applications along with accompanying smart electronic monitoring tools. With wider usage of this training platform, rehabilitation specialists will be able to effectively scale services, while still monitoring quality and ensuring accountability. Thus, the study is highly transformative.

详细描述

The present proposal will evaluate the neural underpinnings of (a) the decline of mobility function in Parkinson's disease (PD), and (b) the effects of an innovative computer-guided dual-task (DT) mobility training platform (complementary approach: exercise intervention). Improved mobility functioning in PD, specifically balance, gait and cognition, directly translates to improved community ambulation as well as increased physical activity and social participation. These benefits are known to have a significant preventive and disease-modifying impact that surpasses any currently available pharmacological interventions. Outcomes of this research will provide new insights into brain plasticity mechanisms and will accelerate further optimization and commercialization of multi-modal mobility-cognitive training applications along with accompanying smart electronic monitoring tools. With wider usage of this training platform, rehabilitation specialists will be able to effectively scale services, while still monitoring quality and ensuring accountability. Thus, the study is highly transformative.

The investigators propose a collaborative project between our research centers at the University of Manitoba and the University of Toronto, to further understand the neural underpinnings of cognition/gait impairment and the effects of DT training in PD.

Cutting-edge behavioural brain imaging methods will be used to identify functional brain metabolic network re-organization and the molecular basis of gait/cognitive impairment. This will be used to evaluate the neurophysiological underpinnings of the DT treadmill training effect, which has repeatedly demonstrated to be clinically effective. The possibility of detecting these changes and localizing the site(s) of brain plasticity will have important implications at several levels. These biomarkers could be used as an indicator of disease severity, outcome measures for neuroprotection studies and other treatment and lifestyle strategies.

Objective 1: To characterize the abnormal brain metabolic pattern in PD patients during DT-walking as compared to healthy age-matched controls.

Objective 2: The investigators will examine whether a 10-week treadmill walking program combined with specific cognitive activities (i.e. true DT walking training known to improve gait function and reduce falls) will "normalize" the brain abnormality (that is identified in Aim 1), or whether it will activate a novel compensatory mechanism and therefore evidence to isolate the region(s) of brain plasticity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
55 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •(PD Participants)
  • •Diagnosed with idiopathic PD, defined by the UK Brain Bank criterion in disease stage 2 - 3 (classified by Hoehn and Yahr scale),
  • •Montreal cognitive assessment (MoCA) scores to be 25 or higher
  • •Age 55-70 years
  • •Stable medications for Parkinson over the past 3 months
  • •Able to walk at least 50m without any assistive device
  • •Episode of FOG in the past 6 months

排除标准

  • •(PD Participants)
  • •The presence of neurological conditions other than PD affecting cognitive abilities.
  • •Any orthopedic impairment affecting gait and balance.
  • •Any cardiovascular impairment limiting the ability to walk for 10-15 minutes on a treadmill;
  • •Abnormal MRI
  • •General contraindications.
  • •Inclusion Criteria: (Healthy Controls)
  • •Age 55-70 years,
  • •Independent community living,
  • •Not receiving any home care or Physiotherapy,
  • •Walking outdoors for exercise for at least 3 times per week,
  • •No neurological conditions affecting mobility or affecting cognitive abilities,
  • •Any orthopedic impairment affecting gait and balance.
  • •Any cardiovascular impairment limiting the ability to walk for 10-15 minutes on a treadmill.
  • •Abnormal MRI and
  • •General contraindications for PET and MRI including severe dyskinesia, diabetes, cardiac pacemakers.
  • •Exclusion Criteria (Healthy Controls):
  • •Any orthopedic impairment affecting gait and balance.
  • •Any cardiovascular impairment limiting the ability to walk for 10-15 minutes on a treadmill.
  • •Abnormal MRI
  • •General contraindications.

研究组 & 干预措施

Dual-task walking Intervention

Experimental

干预措施: Game based treadmill Program (Other)

Conventional Gait Rehabilitation

Active Comparator

干预措施: Conventional Gait Rehabilitation (Other)

Healthy Controls

No Intervention

结局指标

主要结局

NDWP scores

时间窗: 10 weeks

NDWP scores on PET scans of participants will be analysed to identify gait impairment related imagining signatures during single and dual-task walking, and after intervention. They will also be compared to age-matched healthy controls using student t-test.

Step Length Coefficient of Variability

时间窗: 10 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Tony Szturm

Professor

University of Manitoba

研究点 (1)

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