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临床试验/NCT03228888
NCT03228888已完成不适用

Effects of Ecological Rythmic-acoustic Stimulation (E-RAS) on Motor Skills in Individuals

University of Cagliari2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2014年11月1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
32
试验地点
2
主要终点
Walking speed

研究概览

简要总结

The use of rhythmic auditory stimulation (RAS) has been proven useful in the management of gait disturbances induced by Parkinson's disease (PD). Typically, the stimuli used to provide RAS consist of metronome or music-based sounds, which are not related with the auditory experience of walking. Based on previous laboratory research, it is hypothesized that the use of ecological sounds deriving from biological motion (i.e., footstep sounds) could have a greater impact compared to artificial sounds (i.e., metronome sounds), within a rehabilitation program. In a double-blind experiment, it was investigated the effects of 5 weeks of supervised rehabilitation integrated with RAS. Thirty-two individuals affected by PD (age 68.2 ± 10.5, Hoehn and Yahr 1,5-3) were randomly assigned to one of the two conditions (artificial vs. ecological sounds). Spatio-temporal parameters of gait and clinical variables were assessed before the rehabilitation period, at its end, and after a 3-month follow-up. The results revealed that the rehabilitation program integrated with RAS had positive effects on the majority of objective and subjective measures, independently of the type of sound. However, when the two groups were examined separately, the patients assigned to the ecological RAS condition were the only who improved both in terms of cadence and gait speed. Overall, the hypothesized greater effect of the ecological sounds compared to artificial sounds was only partially supported by data.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of PD according to the UK Brain Bank criteria;
  • ability to walk independently;
  • absence of relevant hearing impairments which could prevent the correct perception of the auditory cues;
  • absence of significant cognitive impairment (i.e., Mini-Mental Status Examination (MMSE) > 24; Frontal Assessment Battery (FAB) > 13);
  • absence of psychiatric or severe systemic illnesses;
  • mild-to-moderate disability assessed by means of the modified Hoehn and Yahr (H&Y) staging scale (1,5 ≤ H&Y ≤ 3);
  • no engagement in any rehabilitative program in the 3 months before the beginning of the study

排除标准

  • 未提供

研究组 & 干预措施

Artificial Sounds

Experimental

Participants were provided headphones and a portable MP3 device which played a metronome tick at specified rhythm calculated as follows: a) if a patient's cadence was below the normality, the BPM of the stimulus was set at a value of 10% higher than one's own cadence; b) if a patient's cadence was below, but close to normality (less than 10% difference), the BPM of the stimulus was set at normality values; c) if a patient's cadence was above the normality, the BPM of the stimulus was set at a value equal to one's own cadence.

Participants performed daily 30 minutes of walking assisted by the rhythmic acoustic stimuli.

干预措施: Administration of rhytmic acoustic stimuli for gait training (Other)

Ecological Sounds

Experimental

Participants were provided headphones and a portable MP3 device which played an ecological rhythmic sound obtained by actual footsteps of human at specified rhythm calculated as follows: a) if a patient's cadence was below the normality, the BPM of the stimulus was set at a value of 10% higher than one's own cadence; b) if a patient's cadence was below, but close to normality (less than 10% difference), the BPM of the stimulus was set at normality values; c) if a patient's cadence was above the normality, the BPM of the stimulus was set at a value equal to one's own cadence.

Participants performed daily 30 minutes of walking assisted by the rhythmic acoustic stimuli.

干预措施: Administration of rhytmic acoustic stimuli for gait training (Other)

结局指标

主要结局

Walking speed

时间窗: 5 weeks

Walking speed calculated on a 10 m path using motion-capture system

次要结局

  • Hip Flexion-extension(5 weeks)
  • Knee Flexion-extension(5 weeks)
  • GPS(5 weeks)
  • Ankle Dorsi- Plantar-flexion(5 weeks)

研究者

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

Massimiliano Pau

Associate Professor

University of Cagliari

研究点 (2)

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