Post-ACL Reconstruction Rehab UPSCALER App RCT HPUPM

NCT05498285 | Unknown

• 1 other identifier: JKEUPM-2022-294
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ACL Injury

Outcome Measures

Primary Outcomes (1)

• KOOS score

  Pattient administered scoring system

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Use of UPSCALER App

Behavioral: UPSCALER app

Control

NO INTERVENTION

No app used. Conventional treatment.

Interventions

UPSCALER app BEHAVIORAL

Usage of mobile app to guide rehabilitation after surgery

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Pengajar Universiti Putra Malaysia: lead

Study Sites (1)

Hospital Pengajar Universiti Putra Malaysia

Serdang, Selangor, 42400, Malaysia

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Eng Kee Tan, MBBS

  Hospital Pengajar Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eng Kee Tan, MBBS

CONTACT

+60124707771; ektan86@gmail.com

Mohd Nizlan Mohd Nasir, MS Ortho

CONTACT

+60397695567; ektan86@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 12, 2022
• Study Start: September 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)