A Pilot Single-blind Parallel Randomised Controlled Trial Comparing Mobile App (UPSCALER) to Standard Care in the Rehabilitation of ACL Injury After Reconstructive Surgery
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
Use of UPSCALER App
干预措施: UPSCALER app (Behavioral)
Control
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
