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临床试验/NCT07301671
NCT07301671已完成不适用

Prospective Longitudinal Observational Cohort Study of a Digital Automated Rehabilitation Model for Shoulder Disorders (REHABI) in a Private Physiotherapy Clinic

Universidad Pública de Navarra1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2025年3月17日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
129
试验地点
1
主要终点
Change in global clinical deficit score from baseline to discharge

研究概览

简要总结

This is a prospective longitudinal observational cohort study of patients with shoulder disorders undergoing a standardized rehabilitation program supported by the REHABI digital automated model in a private physiotherapy clinic. The study aims to describe clinical outcomes in routine practice and to optimize a 24-test functional assessment battery based on deficit prevalence, magnitude, and responsiveness.

详细描述

This is a prospective longitudinal observational cohort study of 129 adult patients (≥18 and ≤71 years) with acute non-traumatic shoulder pain and/or dysfunction treated in a private sports physiotherapy clinic in Pamplona, Spain. All patients undergo a standardized rehabilitation program supported by the REHABI automated digital model, which links quantified deficits obtained from a 24-test functional assessment battery to specific exercise prescriptions and progression rules. The study aims to describe clinical outcomes in routine practice (global clinical deficit score, shoulder pain intensity, number of treatment sessions, and days to discharge) and to optimize the initial 24-test battery based on deficit prevalence, magnitude, and responsiveness to change between baseline and discharge.

The main objectives are: (1) to evaluate the clinical effectiveness and feasibility of the REHABI model in routine clinical practice; and (2) to reduce the initial 24-test assessment battery to a smaller core set of tests using mixed criteria based on prevalence, magnitude of deficit, and responsiveness to change.

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 71 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-71 years of age, acute non-traumatic shoulder pain/dysfunction, and access to a smartphone to view the exercises.

排除标准

  • Acute fractures or dislocations, arthritis/arthrosis, osteosarcoma, osteomyelitis, and recent shoulder surgeries.

结局指标

主要结局

Change in global clinical deficit score from baseline to discharge

时间窗: Baseline and discharge (approximately 1-6 months after baseline, depending on clinical evolution)

Global clinical score summarizing the number and magnitude of positive findings in the functional test battery. Higher scores indicate greater functional deficit. Change is calculated as discharge score minus baseline score.

次要结局

  • Change in selected functional tests from the optimized core battery(Baseline and discharge (ranging from 1 month to 6 month after baseline))
  • Number of rehabilitation sessions until discharge(From baseline to discharge (approximately 1-6 months))
  • Days from baseline to clinical discharge(Baseline to discharge (ranging from 1 to 6 months))
  • Change in shoulder pain intensity (Numeric Rating Scale, 0-10)(Baseline and discharge (approximately 1-6 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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