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临床试验/NCT05498285
NCT05498285Unknown不适用

A Pilot Single-blind Parallel Randomised Controlled Trial Comparing Mobile App (UPSCALER) to Standard Care in the Rehabilitation of ACL Injury After Reconstructive Surgery

Hospital Pengajar Universiti Putra Malaysia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
KOOS score

研究概览

简要总结

EXECUTIVE SUMMARY

Research Title An Android Application-Based Delivery of Guided Rehabilitation After Anterior Cruciate Ligament Reconstruction: A Randomised Single-Blinded Pilot Study

Investigators Principle Investigator (Supervisor) : Prof Madya Dr Mohd Nizlan Mohd Nasir Co-investigator (Supervisor) : Dr Khairil Anwar bin Ahmad Hanif Dr Firdati binti Mohamed Saaid Co-Investigator (Student) : Dr Tan Eng Kee

Background Anterior cruciate ligament injuries are a common and significant injury seen in active persons. This injury can adversely affect the patient's daily life, as well as delay or prevent return to sports, in addition to predisposing patients to long-tern knee conditions such as osteoarthritis. Despite surgical advances, ACL reconstruction surgery outcomes are still considered poor, with a low as 55% of patients returning to active sports. One of the key factors that lead to a poorer outcome is the patient's compliance to rehabilitation, causing less than satisfactory results in the post-operative period. With the conventional regime, rehabilitation typically takes one year. Patients tend to drop out of the rehabilitation regime due to its long duration. In order to combat this, the accelerated regime was developed and only took 6 months. This regime has been researched and validated by numerous international publications since its inception. However, compliance remained poor.

Purpose of Study The study aims to assess the feasibility and effectiveness of a smartphone-based application to guide the patient's rehabilitation regime and improve compliance.

Data Gathering and Analysis Data for outcome assessment will be obtained via a patient administered questionnaire called the Knee Injury and Osteoarthritis Outcome Score (KOOS). This scoring system is available for free without licensing requirements, and has been validated by numerous research publications internationally.

Analysis of obtained data will be performed using SPSS version 22. Continuous data will be displayed as mean + SD as well as median.

Conclusion There is a need for a new method of information provision as the country moves towards the age of information technology. This smartphone-based application for guided rehabilitation will be an innovative new method to aid patients.

Lastly, the researchers would like to thank the members of JKEUPM for their time, effort and kind consideration of this research proposal.

详细描述

Study Design:

Single-blinded randomized control pilot study

Study Location:

Hospital Pengajar Universiti Putra Malaysia Orthopaedic Department

Study Duration:

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
Double (Investigator, 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
否

入选标准

  • •Male and female
  • •Patients above the age of 18
  • •Patients with ACL injury who undergo ACL reconstruction surgery with or without meniscectomy
  • •Patients who receive autologous hamstring grafts for ACL reconstruction
  • •Malaysian

排除标准

  • •Patients below the age of 18
  • •Patients unwilling to participate
  • •Patients with concurrent injuries to other structures in the ipsilateral knee e.g. multiligamentous injuries
  • •Non-Malaysian
  • •Patients who require meniscus repair instead of meniscectomy

研究组 & 干预措施

Intervention

Experimental

Use of UPSCALER App

干预措施: UPSCALER app (Behavioral)

Control

No Intervention

No app used. Conventional treatment.

结局指标

主要结局

KOOS score

时间窗: 6 months

Pattient administered scoring system

次要结局

未报告次要终点

研究者

发起方
Hospital Pengajar Universiti Putra Malaysia
申办方类型
Other
责任方
Sponsor

研究点 (1)

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