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临床试验/NCT06727097
NCT06727097招募中不适用

Tracking the Development and Influence of Post-Stroke Sensory Reweighting on Walking and Balance Outcomes

University of Cincinnati2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2024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
招募中
入组人数
45
试验地点
2
主要终点
Walking Speed (10 meter Walk Test)

研究概览

简要总结

The primary objective of this proof-of-concept study is to longitudinally track the development of post-stroke sensory reweighting (PSR), identify associated structural neuroanatomical correlates, and investigate their relationship to walking and fall outcomes.

详细描述

Post-stroke imbalance and walking impairment is a function of diminished sensorimotor integration, motor, and postural control. It impacts over 75% of stroke survivors, and remain a rising cause of falls, fractures, and death in the United States. The associated fear of falling often leads to a downward spiral of health, characterized by reduced walking performance, caregiver dependency, social isolation, and the development of secondary post-stroke medical complications. Although spontaneous biological recovery and intensive clinical rehabilitation may improve balance and walking ability, the extent of recovery is often limited after the first 6-months of stroke (chronic phase). Furthermore, currently available clinical measures such as the Berg Balance Scale and Timed-Up-and-Go lack the specificity and granularity needed to foster the development of individualized and targeted neurorehabilitation interventions. In addition, non-invasive neurostimulation strategies lack specificity due to limited understanding of the most appropriate neuroanatomical targets for optimizing sensorimotor integration. Hence there is an urgent need to identify reliable physiologic and neuroanatomic correlates in the earlier stages of recovery (<6 months), to enable timely and targeted rehabilitation interventions.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First ever clinical stroke
  • Stroke due to ischemia
  • Age 18 years or older
  • Ability to consent by patient (not surrogate), any time prior to acute hospital discharge

排除标准

  • Pre-stroke dependence (modified Rankin Scale score of 3 or more)
  • Isolated brainstem or cerebellar stroke
  • Bilateral acute strokes
  • Co-enrollment in a trial of an intervention through six-month follow-up
  • Inability to maintain follow-up with study procedures through six-month follow-up
  • Contraindication to non-contrast MRI
  • Low likelihood of survival beyond the acute hospitalization, such as malignant cerebral edema
  • Pre-existing co-morbid conditions that significantly affects vision, somatosensory function, vestibular system, orthostasis, coordination or mobility
  • Post stroke mRS>4 or discharge to hospice

研究组 & 干预措施

Stroke Survivors

First ever clinical stroke (ischemic, supratentorial, and unilateral)

干预措施: Posturography (Diagnostic Test)

Stroke Survivors

First ever clinical stroke (ischemic, supratentorial, and unilateral)

干预措施: Walking Speed (Diagnostic Test)

Stroke Survivors

First ever clinical stroke (ischemic, supratentorial, and unilateral)

干预措施: Instrumented 7M Timed UP and GO (Diagnostic Test)

Stroke Survivors

First ever clinical stroke (ischemic, supratentorial, and unilateral)

干预措施: Fall Event Records (Other)

Stroke Survivors

First ever clinical stroke (ischemic, supratentorial, and unilateral)

干预措施: MRI (3T) (Diagnostic Test)

结局指标

主要结局

Walking Speed (10 meter Walk Test)

时间窗: 2, 4, and 6 months Post-Stroke

Self-Selected

Instrumented Timed UP and GO

时间窗: 2, 4, and 6 months Post-Stroke

7M ITUG

Posturography

时间窗: 2, 4, and 6 months Post-Stroke

MCTSIB

Fall Events

时间窗: 2, 4, and 6 months Post-Stroke

Record and characterization of Falls

次要结局

  • Functional Ambulation Category(2, 4, and 6 months Post-Stroke)
  • Walking Speed (10 meter Walk Test)(Walking Speed (10 meter Walk Test))

研究者

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

Oluwole Awosika

Principal Investigator

University of Cincinnati

研究点 (2)

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