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临床试验/NCT04374331
NCT04374331已完成不适用

The Effect of Video-Assisted Training on Upper Extremity Problems and Functions in Patients Undergoing Rotator Cuff Repair: A Randomized Controlled Trial

Mersin University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Change upper extremity functions

研究概览

简要总结

This randomized controlled trial evaluates the effect of video-assisted training (VAT) on upper extremity problems and functions in rotator cuff repair (RCR) patients. The hypothesis of this study is that VAT decreases upper extremity problems and increases functions after RCR.

详细描述

Methods: Forty-eight elective RCR patients were randomly assigned to VAT and control groups. VAT group (n=24) received VAT including early post-operative care for RCR, activities of daily living (ADL) and gradual exercise program while control group (n=24) received routine care. Primary outcomes were upper extremity problems and functions, assessed using Disabilities of the Arm, Shoulder and Hand (DASH) and Modified Constant-Murley (MCM) scores. Secondary outcomes were complications within three months. Outcomes were collected at baseline, after six weeks and three months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Before inclusion, the patients were informed about the duration of care as usual, which could be six weeks or three months. The patients were blinded to the group assignment due to the nature of the intervention. The researchers involved in the data analysis and statistics stages were blinded to the group assignment, too. However, those involved in the running of the study were not blinded.

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

  • Patients who
  • underwent elective RCR for the first time;
  • whose arm was suspended and fixed for up to three weeks after RCR;
  • had an SMMT score of ≥23 points;

排除标准

  • Patients who
  • had been diagnosed with a psychiatric illness;
  • have any history of an upper extremity fracture or a rheumatologic disease;

结局指标

主要结局

Change upper extremity functions

时间窗: Change from baseline the Modified Constant-Murley score at 3 months

The patients' upper extremity functions were assessed using the Modified Constant-Murley score. The Modified Constant-Murley score consists of 100 points in total: 15 points for pain, 20 points for daily of living activities, 40 points for movement and 25 points for strength. The maximum MCM score is 100 points, with higher scores indicating better shoulder functions

Change upper extremity problems

时间窗: Change from baseline the Disabilities of the Arm, Shoulder and Hand score at 3 months

The patients' upper extremity problems were assessed using the Disabilities of the Arm, Shoulder and Hand. The possible scores on each part of the questionnaire range from 0 to 100, with higher scores indicating a higher disability level of patients (0=no disability, 100=maximum disability)

次要结局

  • Change of complications(1st and 3rd months)

研究者

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

Gulay ALTUN UGRAS

Associate professor

Mersin University

研究点 (2)

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