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临床试验/NCT04887753
NCT04887753Unknown不适用

Understanding the Effect of Variances on Precision in Predictive Coding When Walking to Music and Metronomes in Persons With Cerrebellar Lesions

Hasselt University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年4月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Perceptual tempo and rhythm judgements

研究概览

简要总结

This study is a case-control study, involving persons with persons with cerebellar lesions and healthy controls. The study contains 1 descriptive and 3 experimental sessions. In the descriptive session, participant's clinical motor and cognitive functions are collected. In the first experimental session, participant's beat perception and synchronisation abilities is examined within a finger tapping paradigm. In the following experimental sessions participants synchronsiation abilities is examined during walking paradigms, to music and metronomes, with period and phase auditory manipulations. In the latter twp sessions, apart from outcome measures of synchronization the following will be collected as well: brain activity using EEG recordings, spatio-temporal gait parameters, perceived fatigue, perceived motivation and perceived speed of walking.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • •diagnosis of cerrebellar lesions
  • •walking speed 0.8-1.2m/s, ability to walk for 6 minutes continuously (canes and rollators are permitted)

排除标准

  • •cognitive impairment impeding understanding of
  • •instructions,
  • •beat amusia,
  • •deafness,
  • •pregnancy

研究组 & 干预措施

persons with cerebellar lesions

Experimental

干预措施: Synchronisation abilities (Other)

Healthy controls

Active Comparator

干预措施: Synchronisation abilities (Other)

结局指标

主要结局

Perceptual tempo and rhythm judgements

时间窗: week 1

subjective indications in regards to what the participants hear in terms

Asynchrony

时间窗: week 1

timing difference between the tap and the beat

6 minute walking test

时间窗: baseline

gait pattern and endurance

cerebellar affective syndrome test

时间窗: baseline

cognitive test

Motricity Index of dorsi flexors, knee extensors and hip flexors

时间窗: baseline

Muscle weakness

Scale for the assessment and rating of ataxia

时间窗: baseline

ataxia

64 channel EEG measurement

时间窗: week 1

neural correlates of entrainment

Time up and Go test

时间窗: baseline

Balance

Dual task questionnaire

时间窗: baseline

troubles a person have when performing a dual task during daily activity

Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts

时间窗: baseline

Spasticity

Dynamic gait index

时间窗: baseline

dynamic balance

Activities-specific balance confidence scale

时间窗: baseline

rating of balance confidence in performing activities of daily life

Modified fatigue impact scale

时间窗: baseline

effect of fatigue

Hospital Anxiety and Depression Scale

时间窗: baseline

determine the levels of anxiety and depression

Relative phase angle

时间窗: week 3

asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)

Resultant Vector Length

时间窗: week 3

synchronisation consistency

Resultant Vector Length

时间窗: week 2

synchronisation consistency

Resultant Vector Length

时间窗: week 1

synchronisation consistency

Relative phase angle

时间窗: week 2

asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)

次要结局

  • Cadencce(week 3)
  • Stride length(week 3)
  • Double Support(week 3)
  • Perceived motivation(week 3)
  • Perceived cognitive and physical fatigue(week 3)
  • Perceived walking speed(week 3)
  • 64 channel EEG measurement (only conducted in 4 PwMS and HC)(week 3)
  • Speed(week 3)
  • Stride length(week 2)
  • Cadencce(week 2)
  • Speed(week 2)
  • Double Support(week 2)
  • Perceived cognitive and physical fatigue(week 2)
  • Perceived motivation(week 2)
  • Perceived walking speed(week 2)
  • 64 channel EEG measurement (only conducted in 4 PwMS and HC)(week 2)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Feys

Principal Investigator

Hasselt University

研究点 (1)

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