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临床试验/NCT06223529
NCT06223529招募中不适用

The Neural Mechanisms of Music Intervention for Chronic Arm Hemiparesis Following Stroke: A Single Case Series EEG Study

Anglia Ruskin University1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2024年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5
试验地点
1
主要终点
Electroencephalogram (EEG): Power in EEG Alpha and Beta frequency bands

研究概览

简要总结

The aims of the study are to recruit five participants with stroke upper limb hemiparesis and determine the effects on neural reorganisation of a three-week music intervention using electroencephalogram measures.

Secondly, the researchers will measure for changes in arm function before and after the three-week music intervention.

This is a single-arm pre-/post experiment

Primary research questions:

What are the neuroplastic changes induced by Therapeutic Instrumental Music Performance (TIMP)?

Secondary research questions What are the functional changes in hemiparetic arm and hand induced by TIMP?

Participants will be recruited once they have completed their statutory community stroke rehabilitation.

They will receive 15 X music therapy sessions in their home over three-weeks. Exercises will be delivered by trained clinicians, including music therapists and stroke rehabilitations specialists.

Exercises will be facilitated for full range of arm movement, using a range of percussion instruments on stands and handheld, and iPad with touchscreen instruments, which include keyboards and string instruments that can be played using pinch-grip, holding a stylus/plectrum.

Pre-/post intervention period EEG recordings will made. Stroke Specific Quality of Life (SSQoL), Action Research Arm Test and nine-hole-peg-test data will be collected from participants in their homes at weeks: 1, 4, 7 and 10.

详细描述

Recruitment A treating clinician from collaborating healthcare Trust will inform the patients about the study and ask if they are interested. If so, they will provide them with the participant information sheet and ask if the chief investigator (CI) can contact them. Following this, the CI will contact the patient and manage consent.

Once recruited, an assessor will visit the participants in their home to conduct the Action Research Arm Test (ARAT) and nine-hole-peg-test (9HPT) and Stroke Specific Quality of Life Questionnaire (SSQoL) baseline assessment.

After the baseline assessment, the CI will contact the participants to schedule pre-intervention assessments and the 15 sessions over three-weeks. The CI will schedule all assessment and EEG lab visits with participants and Dr Maidhof.

Music Intervention Equipment for music intervention delivery will be brought to the participants' homes and will comprise: Untuned percussion, iPad, guitar.

The iPad and percussion will facilitate every type of hand, finger and arm movement and all movement sequences required to perform activities of daily living. Exercises will progress to facilitate greater range and frequency of movement and complexity (number of instruments or screen targets hit in a sequence) without compromising quality (i.e. avoiding the introduction of compensatory movements).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

盲法说明

The person collecting data on quality of life and arm function in participants' homes will be blinded to whether pre- or post intervention

入排标准

年龄范围
18 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ischemic stroke
  • Three weeks to 60 months post-stroke
  • 12 to 49/57 Action Research Arm Test (ARAT) score *
  • Able to follow instructions and consent
  • Right-hand dominant

排除标准

  • Hemorrhagic stroke
  • No movement in arm
  • Unable to move thumb and one finger. Loss of sensation and proprioceptive impairment will not lead to exclusion.
  • Unable to consent to participate
  • Currently receiving music therapy
  • Left-hand dominant
  • Ambidextrous
  • Not registered with a GP. We will require GP details to inform them in case of any incidental findings in the EEG.

结局指标

主要结局

Electroencephalogram (EEG): Power in EEG Alpha and Beta frequency bands

时间窗: baseline: pre-intervention, immediately after the intervention

Power in EEG Alpha and Beta frequency bands (event-related synchronization and de-synchronization) during simple motor tasks

次要结局

  • Electroencephalogram (EEG): Frontal Alpha Asymmetry(baseline: pre-intervention, immediately after the intervention)
  • Electroencephalogram (EEG): Amplitude of P3 event-related potential(baseline: pre-intervention, immediately after the intervention)
  • Nine hole peg test(Baseline (week 1), pre-intervention (week 4), post-intervention (week 7), Follow-up (week 10))
  • Action Research Arm Test (ARAT)(Baseline, pre-intervention (week 4), post-intervention (week 7), follow-up (week 10))

研究者

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

Alex Street

Senior Research Fellow (Music therapy)

Anglia Ruskin University

研究点 (1)

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