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临床试验/NCT07321444
NCT07321444已完成不适用

Effectiveness of Telerehabilitation in Shoulder Pathology

Instituto de Investigación Sanitaria Aragón2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2025年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
2
主要终点
Shoulder functionality

研究概览

简要总结

A randomized clinical trial will be conducted to evaluate the effectiveness of telerehabilitation compared to in-person physiotherapy in the treatment of rotator cuff injuries of the shoulder. Follow-up assessments will be performed at 2, 5, and 8 weeks. Scales will be used to evaluate shoulder function, quality of life, pain perception, and satisfaction with the digital tool.

详细描述

Digital health is undergoing significant development in various healthcare settings, especially in primary care. Digital physiotherapy, or telerehabilitation, is a resource that promotes self-care and allows for remote monitoring and follow-up. This study focuses on its application to degenerative rotator cuff disease of the shoulder. This is justified by its high prevalence and the geographical dispersion of the population served by the Primary Care Physiotherapy Unit of Teruel Ensanche. Objectives: The main objective is to evaluate the effectiveness of a primary care telerehabilitation program for patients with degenerative rotator cuff disease of the shoulder, compared to traditional physiotherapy. Secondary objectives are to assess patients' perception and satisfaction with this intervention and to analyze the usability and acceptance of the telerehabilitation program. Methodology: A 12-week randomized clinical trial will be conducted at the Teruel Ensanche Health Center. A sample of 68 adults aged 34 to 87 years with degenerative rotator cuff disease of the shoulder was estimated. Participants require internet access and an electronic device. The variables measured: shoulder function (Constant-Murley test), degree of disability (DASH questionnaire), quality of life (COOP/WONCA questionnaire), and pain perception (numerical rating scale). The intervention group (IG) receive an individualized program with remotely guided and supervised exercises, supplemented by a weekly in-person session. The control group (CG) receive standard treatment: 10 in-person physiotherapy sessions, followed by unsupervised home exercises. Assessments will be conducte at baseline and at 2, 5, 8, and 12 weeks.

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
Single (Outcomes Assessor)

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

  • Minimum age
  • Diagnosis of degenerative shoulder rotator cuff disease.
  • Internet access.
  • Access to a video calling device.

排除标准

  • Previous shoulder surgery.
  • Cognitive impairment that prevents them from performing the task.

研究组 & 干预措施

Telerehabilitation

Experimental

exercises supervised by videoconference

干预措施: telerehabilitation in physiotherapy (Procedure)

Face to face physiotherapy

Active Comparator

Face to face exercise sessions in the physiotherapy room

干预措施: face to face physiotherapy (Procedure)

结局指标

主要结局

Shoulder functionality

时间窗: At baseline, at 2, 5, 8, and 12 weeks.

Shoulder function will be analyzed using the test Constant Murley.A maximum total score of 100 indicates optimal health and mobility in this joint. The results are divided into four main categories: pain (15 points), activities of daily living (20 points), mobility (40 points), and strength (25 points). It is essential to distinguish between scores below 60, which denote a severely dysfunctional state, and those above 80, which reflect optimal functionality.

次要结局

  • Health-related quality of life(At baseline, and at 2, 5, 8, and 12 weeks.)
  • Level of shoulder disability(At baseline, 5 and 12 weeks)
  • Pain perception(At baseline, 2,5,8 and 12 weeks)
  • Level of satisfaction with telerehabilitation(At 12 weeks.)

研究者

发起方
Instituto de Investigación Sanitaria Aragón
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yolanda Marcen Roman

PhD

Instituto de Investigación Sanitaria Aragón

研究点 (2)

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