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临床试验/NCT04977609
NCT04977609Unknown不适用

Music in Action: A Music-based Virtual Reality Intervention for Upper Limb Motor Rehabilitation in Post-stroke Hemiparetic Patients

Catholic University of the Sacred Heart2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2021年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
45
试验地点
2
主要终点
The Chedoke arm and Hand Activity Inventory (CAHAI) - short form (Barreca, 2013)

研究概览

简要总结

Hemiparesis affects the majority of stroke patients in the acute phase. In post-stroke motor rehabilitation patients can re-learn motor sequences through repetitive training. Research showed that virtual reality (VR) can be effectively used in upper limb motor rehabilitation by training motor coordination and gestures in an immersive virtual environment. Another promising line of intervention in post-stroke rehabilitation is the use of music, with evidence supporting the notion that a rhythmic accompaniment promotes the recovery of motor coordination in patients with hemiparetic stroke. Furthermore, studies showed a beneficial effect of the observation of movements performed by a third person in patients with post-stroke hemiparesis. Based this evidence, the present study aims at testing the feasibility and efficacy of a novel music-based VR intervention designed for upper limb motor rehabilitation in post-stroke hemiparetic patients. The treatment consists in upper limb repetitive training activities through the imitation of movements synchronized with a musical accompaniment and is delivered in 10 sessions over 2 weeks, supervised by a physical therapist. Participants wear a VR headset through which they observe egocentric 180° 3D videoclips. The experimental condition (group A) will be compared with a no-music condition (group B), to test the specific effect of music, and with traditional physiotherapy rehabilitation (group C), to test the efficacy of the approach. The investigators expect that the patients undergoing the experimental intervention (group A and group B) will show a greater upper limb motor function improvement, as compared to the active control group. As a secondary endpoint the investigators expect the music component to induce a greater motor improvement as compared to the experimental condition without music.

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
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Post-stroke patients in acute/subacute phase
  • Upper limb hemiparesis (Ashworth scale: 0-2; MRC scale: 3-5)
  • Age between 18 and 80 years
  • Currently enrolled in inpatient rehabilitation

排除标准

  • Psychiatric disorders,
  • MMSE rating < 24
  • Difficulty with visual-spatial exploration
  • Visual deficits.

研究组 & 干预措施

TAU

Active Comparator

Treatment as usual (TAU). Patients will be engaged in upper limb repetitive training activities through traditional physiotherapy rehabilitation.

干预措施: TAU (Behavioral)

结局指标

主要结局

The Chedoke arm and Hand Activity Inventory (CAHAI) - short form (Barreca, 2013)

时间窗: 2 weeks post-test

Hand activity scale

Motricity Index (Collin, 1990)

时间窗: 2 weeks post-test

Motricity scale

Medical Research Council (MRC) Muscle strength scale (Paternostro-Slug et al., 2008)

时间窗: 2 weeks post-test

Muscle strenght scale

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

Alice Cancer

Principal Investigator

Catholic University of the Sacred Heart

研究点 (2)

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