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临床试验/NCT05978596
NCT05978596招募中不适用

Postural Alignment in Post-stroke Participants: Providing New Insights in the Time Course of a Misperception of Verticality and Its Characteristics

Universiteit Antwerpen2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年10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
40
试验地点
2
主要终点
Change in Subjective Hapic Vertical constant error

研究概览

简要总结

Little is known about the time course of verticality perception after stroke. This study aims to assess:

  • The time course of verticality perception (Subjective Visual, Haptic and Postural Vertical; resp., SVV, SHV, SPV);
  • The longitudinal interaction of the recovery of spatial disorders (e.g., different types of neglect, lateropulsion) with verticality perception;
  • The longitudinal interaction of motor function and outcomes (such as paresis, sitting balance and standing balance) and verticality perception.

The participants will be repetitively assessed during the subacute phase post-stroke, to evaluate the time course of:

  • The SVV, SHV and SPV;
  • Spatial disorders (visuospatial and personal neglect, lateropulsion)
  • Motor function (lower limb strength, sitting and standing balance, functionality in ADL, trunk performance)

详细描述

For a correct vertical alignment of the body with the gravitational vector, the patient must be able to accurately perceive verticality. Estimation of verticality is a complex process, suggested to be based on internal references derived from the integration of multisensory input (e.g. visual, vestibular and somatosensory). Due to a brain lesion, this complex process can be hampered, resulting in a deviation of the subjective vertical.

Different modalities of verticality perception can be assessed, including the Subjective Visual (SVV), Haptic (SHV) and Postural (SPV) Vertical. Previous studies reported a deviation of the subjective vertical in post-stroke patients. These deviations are associated with poorer balance performance. However, some stroke participants have more difficulties with accurately estimating a vertical position as compared to others. This increased magnitude is often seen in participants with lateropulsion or spatial neglect.

Although previous studies showed an increased deviation of the subjective vertical in post-stroke patients, little is known about the recovery of this misperception of verticality. Especially in patients with spatial disorders (e.g., lateropulsion or (different subtypes of) neglect), there is clear lack of studies assessing the longitudinal recovery of a misperception of verticality. Knowledge about the spontaneous recovery of a deviated verticality perception and its association with spatial disorders, will give insights in the role of a misperception of verticality in these disorders.

Although disturbances in perceiving verticality and decreased balance performance seems to be related, it is unclear how these disturbances exactly impacts balance and functional outcome. A longitudinal interaction between verticality perception and motor function will be evaluated.

Participants will be recruited from rehabilitation hospital Revarte (Edegem) or AZ Monica (Antwerp). Participants will be included at 3 or 5 weeks post-stroke and evaluation will take place at 3, 5, 8 and 12 weeks post-stroke. Also, in healthy participants the SVV, SHV and SPV will be evaluated to obtain normative data.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •First-ever, MRI- or CT-confirmed, ischemic or hemorrhagic supratentorial stroke;
  • •Able to give written informed consent.

排除标准

  • •Bilateral lesions;
  • •Vestibular dysfunction, symptomatic orthostatic hypotension or other pre-existing neurological conditions that could interfere with the assessments;
  • •Inability to understand and follow basic verbal instructions;
  • •Hemianopsia or other visual field deficits (glasses or corrective lenses are allowed)
  • •And a group of healthy controls to obtain normative data. These participants are eligible for inclusion if they are between 18 and 90 years old and do not suffer from vestibular dysfunction, symptomatic orthostatic hypotension or other neurological conditions that could interfere with the assessment.

结局指标

主要结局

Change in Subjective Hapic Vertical constant error

时间窗: Change from 8 to 12 weeks

Reflects the difference between the perceived haptic vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.

Change in Subjective Postural Vertical constant error

时间窗: Change from 8 to 12 weeks

Reflects the difference between the perceived postural vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.

Change in Subjective Haptic Vertical unsigned error

时间窗: Change from 8 to 12 weeks

Reflects the difference between the perceived haptic vertical and the gravitational vector, irrespective of the direction.

Change in Subjective Postural Vertical unsigned error

时间窗: Change from 8 to 12 weeks

Reflects the difference between the perceived postural vertical and the gravitational vector, irrespective of the direction.

Change in Subjective Visual Vertical variability

时间窗: Change from 8 to 12 weeks

Reflects the intra-individual variability (standard deviation of the trials)

Change in Subjective Haptic Vertical variability

时间窗: Change from 8 to 12 weeks

Reflects the intra-individual variability (standard deviation of the trials)

Change in Subjective Visual Vertical unsigned error

时间窗: Change from 8 to 12 weeks

Reflects the difference between the perceived visual vertical and the gravitational vector, irrespective of the direction.

Change in Subjective Visual Vertical constant error

时间窗: Change from 8 to 12

Reflects the difference between the perceived visual vertical and the gravitational vector, with the direction (ipsi- vs contralesional) considered.

Change in Subjective Postural Vertical variability

时间窗: Change from 8 to 12 weeks

Reflects the intra-individual variability (standard deviation of the trials)

次要结局

  • Trunk Impairment test (dynamic and coordination subscales)(3, 5, 8, 12 weeks post-stroke)
  • Weight bearing asymmetry (standing)(3, 5, 8, 12 weeks post-stroke)
  • Burke Lateropulsion Scale(3, 5, 8, 12 weeks post-stroke)
  • Berg Balance Scale - item quiet standing for 2 minutes(3, 5, 8, 12 weeks post-stroke)
  • Trunk Control Test - item quiet siting for 30 seconds(3, 5, 8, 12 weeks post-stroke)
  • Line Bisection Test(3, 5, 8, 12 weeks post-stroke)
  • Visuospatial Search Time Test(3, 5, 8, 12 weeks post-stroke)
  • Tactile extinction test(3, 5, 8, 12 weeks post-stroke)
  • Scale for Contraversive Pushing(3, 5, 8, 12 weeks post-stroke)
  • Motricity index - lower limbs(3, 5, 8, 12 weeks post-stroke)
  • Fluff test(3, 5, 8, 12 weeks post-stroke)
  • Broken Heart Test(3, 5, 8, 12 weeks post-stroke)

研究者

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

Wim Saeys

Professor Dr. Wim Saeys

Universiteit Antwerpen

研究点 (2)

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