ACL InjuryNCT05498285
Post-ACL Reconstruction Rehab UPSCALER App RCT HPUPM
A study testing UPSCALER app in people with ACL Injury, run by Hospital Pengajar Universiti Putra Malaysia at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ACL Injury
- What is being tested?
- UPSCALER app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Sep 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Pengajar Universiti Putra Malaysia
Serdang, Selangor, 42400
About this study
Official title: A Pilot Single-blind Parallel Randomised Controlled Trial Comparing Mobile App (UPSCALER) to Standard Care in the Rehabilitation of ACL Injury After Reconstructive Surgery
EXECUTIVE SUMMARY
Research Title An Android Application-Based Delivery of Guided Rehabilitation After Anterior Cruciate Ligament Reconstruction: A Randomised Single-Blinded Pilot Study
Read more
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.
Read the detailed description
Study Design:
Single-blinded randomized control pilot study
Study Location:
Hospital Pengajar Universiti Putra Malaysia Orthopaedic Department
Study Duration:
1 year (September 2022 to August 2023)
Study Population:
Consenting patients from HPUPM Orthopaedic Department, SIASCOE Unit who are undergo elective arthroscopic ACL reconstruction surgery
Sample Size:
The sample size for this study was concluded to be 30 based on the objectives. Different sample sizes were calculated and the highest number was taken. (See Appendix A)
Patient Recruitment:
Patients from the SIASCOE clinic who fall within the inclusion criteria will be informed regarding this research using the patient's information sheet. Should they choose to join the research; consent will be obtained with a witness present.
They will also be informed as any patient would, that the surgery will be performed by the same team using the anatomical ACL reconstruction technique. Concomitant procedures such as meniscectomy or meniscal repair, operative time as well as tourniquet time and pressure will be recorded as with any other patient who undergoes an ACL reconstruction. Post-operative precautions will be taken as with any patient. A hinge knee brace and a compressive wrap will be used immediately post-op, cryocuff therapy started once patient is back in the ward.
Patient Randomization Patients will be randomized into treatment or control arm based on the last digit of their UPM registration number. Even numbers for treatment, and odd numbers for control.Patient forms will be colour coded to either red or blue for blinding of the researcher. Patients in the control arm will not be informed of the usage of the app as it may create a bias.
Data Collection and Researcher Blinding KOOS forms will be provided to the participant. They will be placed in a private setting during the self-administered assessment with an investigator available for any queries. Privacy and confidentiality will be ensured and there will be no personal data included in the KOOS forms. All participants will be assigned an identification number known only to the primary researcher and all KOOS forms will be colour coded to indicate the randomly assigned group of the participant.
SIRAS assessment forms will also be provided to patients during follow up to assess adherence to the rehabilitation regime. This assessment form will be filled by the physician and consist of three items that assess the patient's intensity during rehabilitation, ability to follow instructions, and their receptiveness to the rehabilitation.
Two researchers will be allocated for data collection. Researcher A will obtain data related to KOOS and SIRAS scoring. This researcher will be blinded and provided with colour coded forms according to the group that the patient has been randomized to.
Researcher B will obtain data related to acceptance of the mobile app. This researcher is unable to be blinded and will only be allocated to patients in the treatment group.
The data collected by this Researcher B will be stored in a separate location from the data collected by Researcher A until the study is completed. They will only be compiled immediately prior to data analysis.
- Conditions
- ACL Injury
- Being tested
- UPSCALER app
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPSCALER appBehavioural
Usage of mobile app to guide rehabilitation after surgery
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Use of UPSCALER App Receives: Behavioral: UPSCALER app |
| Control | No intervention | No app used. Conventional treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS score
Pattient administered scoring system
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Pengajar Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eng Kee Tan, MBBS, Principal investigator, Hospital Pengajar Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498285
- Sponsor's protocol ID
- JKEUPM-2022-294
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Single-blind Parallel Randomised Controlled Trial Comparing Mobile App (UPSCALER) to Standard Care in the Rehabilitation of ACL Injury After Reconstructive Surgery
- ClinicalTrials.gov ID
- NCT05498285
- Acronym / sponsor ID
- JKEUPM-2022-294
- Conditions
- ACL Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospital Pengajar Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Design:
Single-blinded randomized control pilot study
Study Location:
Hospital Pengajar Universiti Putra Malaysia Orthopaedic Department
Study Duration:
1 year (September 2022 to August 2023)
Study Population:
Consenting patients from HPUPM Orthopaedic Department, SIASCOE Unit who are undergo elective arthroscopic ACL reconstruction surgery
Sample Size:
The sample size for this study was concluded to be 30 based on the objectives. Different sample sizes were calculated and the highest number was taken. (See Appendix A)
Patient Recruitment:
Patients from the SIASCOE clinic who fall within the inclusion criteria will be informed regarding this research using the patient's information sheet. Should they choose to join the research; consent will be obtained with a witness present.
They will also be informed as any patient would, that the surgery will be performed by the same team using the anatomical ACL reconstruction technique. Concomitant procedures such as meniscectomy or meniscal repair, operative time as well as tourniquet time and pressure will be recorded as with any other patient who undergoes an ACL reconstruction. Post-operative precautions will be taken as with any patient. A hinge knee brace and a compressive wrap will be used immediately post-op, cryocuff therapy started once patient is back in the ward.
Patient Randomization Patients will be randomized into treatment or control arm based on the last digit of their UPM registration number. Even numbers for treatment, and odd numbers for control.Patient forms will be colour coded to either red or blue for blinding of the researcher. Patients in the control arm will not be informed of the usage of the app as it may create a bias.
Data Collection and Researcher Blinding KOOS forms will be provided to the participant. They will be placed in a private setting during the self-administered assessment with an investigator available for any queries. Privacy and confidentiality will be ensured and there will be no personal data included in the KOOS forms. All participants will be assigned an identification number known only to the primary researcher and all KOOS forms will be colour coded to indicate the randomly assigned group of the participant.
SIRAS assessment forms will also be provided to patients during follow up to assess adherence to the rehabilitation regime. This assessment form will be filled by the physician and consist of three items that assess the patient's intensity during rehabilitation, ability to follow instructions, and their receptiveness to the rehabilitation.
Two researchers will be allocated for data collection. Researcher A will obtain data related to KOOS and SIRAS scoring. This researcher will be blinded and provided with colour coded forms according to the group that the patient has been randomized to.
Researcher B will obtain data related to acceptance of the mobile app. This researcher is unable to be blinded and will only be allocated to patients in the treatment group.
The data collected by this Researcher B will be stored in a separate location from the data collected by Researcher A until the study is completed. They will only be compiled immediately prior to data analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: UPSCALER appUse of UPSCALER App |
| Control | No intervention | –No app used. Conventional treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UPSCALER appUsage of mobile app to guide rehabilitation after surgery | Behavioural | Intervention |
Primary outcome
KOOS score
Time frame: 6 months
Pattient administered scoring system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for ACL Injury
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Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eng Kee Tan, MBBS principal investigator
Hospital Pengajar Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UPSCALER app in people with ACL Injury, run by Hospital Pengajar Universiti Putra Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eng Kee Tan, MBBS (+60124707771, ektan86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.