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临床试验/NCT07411534
NCT07411534Enrolling By Invitation不适用

Individual vs Co-Treatment in Acute Stroke Rehabilitation and Evaluation

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 567 人开始时间: 2026年9月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
567
试验地点
1
主要终点
Final Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Score

研究概览

简要总结

This is a single center, pragmatic, randomized trial comparing the effectiveness of two commonly used approaches (co-treatment and individual treatment) in acute care rehabilitation.

详细描述

Individual and co-treatment are both widely used to deliver physical therapy (PT) and occupational therapy (OT) for patients admitted to the hospital for acute stroke. Studies have shown that patients with stroke who participate in hospital PT and OT have improved function upon discharge. However, there is a lack of evidence informing which patients are best suited for individual versus co-treatment, or which delivery method more effectively improves functional outcomes.

This gap in knowledge presents a unique opportunity to advance stroke rehabilitation. This study aims to compare the two approaches and their resulting functional outcomes through a randomized trial-an approach never previously undertaken-to determine whether individual or co-treatment leads to better patient recovery. The findings have the potential to optimize rehabilitation and the delivery of PT and OT for future patients with acute stroke.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inpatient admission to the neurology stroke service AND
  • Orders placed for both PT and OT within 96 hours of hospital admission

排除标准

  • Patient is known to be <18 years
  • Patient is known to be a prisoner
  • Patient is known to be pregnant
  • Prior evaluation or treatment by PT and/or OT while admitted under the stroke service before study enrollment
  • Clinician determines that either individual PT and OT or co-treatment is required or contraindicated for the optimal care of the patient

研究组 & 干预措施

Co-treatment

Active Comparator

干预措施: Co-treatment (Other)

Individual Treatment

Active Comparator

干预措施: Individual Treatment (Other)

结局指标

主要结局

Final Activity Measure for Post-Acute Care (AM-PAC) Basic Mobility Score

时间窗: Prior to discharge or at 28 days post-enrollment, whichever comes first.

Final PT assessment score. Assessments are conducted by PTs during every session on 6 mobility items: 1) turning over in bed 2) moving from lying to sitting edge of bed 3) moving from bed to chair 4) standing up from chair 5) walking in hospital room 6) climbing 3-5 steps. Therapists rate the patient's difficulty performing specified activities using a 4-point scale, with 1 indicating total assistance and 4 indicating no assistance needed. Scores from each of the 6 activities are totaled. Final scores range from 6-24, with lower scores indicating more severe impairment.

Final Activity Measure for Post-Acute Care (AM-PAC) Daily Activity Score

时间窗: Prior to hospital discharge or at 28 days post-enrollment, whichever comes first.

Final OT assessment score. Assessments are conducted by OTs during every session on 6 activities including: 1) lower body dressing, 2) upper body dressing, 3) toileting, 4) grooming, 5) eating, 6) bathing. Therapists rate difficulty performing specified activities using a 4-point scale, with 1 indicating total assistance and 4 indicating no assistance needed. Scores from each of the 6 activities are totaled. Final scores range from 6-24, with lower scores indicating more severe impairment

次要结局

  • Discharge Disposition(At time of discharge.)

研究者

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

Sarah Welch

Assistant Professor

Vanderbilt University Medical Center

研究点 (1)

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