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临床试验/NCT05904171
NCT05904171已完成不适用

Cognitive, Affective, and Motor Effects of Tangotherapy in Parkinson's Disease

Istituto Auxologico Italiano2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2023年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
45
试验地点
2
主要终点
Change in Parkinson's Disease Cognitive Rating Scale (PD-CRS) - total score

研究概览

简要总结

Neuroscientific research has shown a close relationship between physical fitness and cognition, showing a positive effect of physical activity (e.g., aerobic activity) on the maintenance of psycho-cognitive well-being in the elderly. In particular, dancing seems to be very effective, as it involves both motor and multisensory aspects (touch, sight, hearing, proprioception), stimulating memory, motor learning and social interaction. In fact, dance increases sensory-motor skills and cognitive performance in the neurologically healthy elderly. Dance-based therapeutic approaches, in particular Argentine tango, have also been implemented in the context of neurodegenerative pathologies, including Parkinson's disease (PD) where motor (i.e., tremors, postural instability, motor slowdown) and cognitive difficulties (e.g., executive deficits) may coexist. Most of these studies have so far demonstrated a significant improvement in balance and a reduction in motor symptoms, while evidence regarding cognitive and emotional benefits brought about by dance remains limited. When investigated, cognitive benefits have often been evaluated at the level of global cognition (i.e., screening tests), without a detailed characterization of the effects of tango on cognitive and affective functioning (e.g., executive functions, social cognition, depressive symptoms), central aspects in Parkinson's disease.

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
None

入排标准

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

入选标准

  • Clinical diagnosis of mild-moderate Parkinson's Disease (modified Hoehn&Yahr Scale 1-3)

排除标准

  • Having attended Argentine Tango classes in the past year;
  • Having attended Physical Therapy rehabilitation in the past month;
  • Other neurological diseases (e.g., stroke, traumatic brain injury, brain tumors)
  • Any clinical condition not compatible with physical activity
  • Deep Brain Stimulation of infusion pumps implants

研究组 & 干预措施

Tangotherapy

Experimental

2 hours of group-based Tangotherapy, weekly, for 6 weeks

干预措施: Tangotherapy (Behavioral)

Physical Activity

Active Comparator

2 hours of group-based physical activity, weekly, for 6 weeks

干预措施: Physical activity (Behavioral)

结局指标

主要结局

Change in Parkinson's Disease Cognitive Rating Scale (PD-CRS) - total score

时间窗: At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up

A battery of cognitive tests of memory, selective attention, visuo-spatial skills, and flexibility.

Change in Hospital Anxiety and Depression Scale (HADS) - total score

时间窗: At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up

A scale assessing depressive and anxiety symptoms.

Change in Stroop Task - reading time

时间窗: At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up

A test assessing cognitive inhibition.

Change in 6 minutes walking Test (6MWT) - Distance Walked

时间窗: At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up

A test assessing walking performance; i.e., distance walked in 6 minutes.

Change in Health-related quality of Life (EQ-5D-5L) - total score

时间窗: At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up

A questionnaire about quality of life in different health-related domains.

Change in 10 meters walking test (10mWT) - Execution Time

时间窗: At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up

A test assessing walking performance.

Change in Timed Up and Go (TUG) test - Execution Time

时间窗: At the beginning of the treatment, at the end of the treatment (i.e., after 6 weeks), and at 45 days follow-up

A test used to assess a person's mobility.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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