Telerehabilitation for Anterior Cruciate Ligament Reconstruction - TAR Program in Adolescents (TAR)

March 22, 2023 updated by: Siao Hui Toh, KK Women's and Children's Hospital

Feasibility and Effectiveness of Telerehabilitation for Anterior Cruciate Ligament Reconstruction - TAR Program Involving a Motion Capture Mobile Application in Adolescents: A Pilot Randomised Controlled Trial

Anterior cruciate ligament (ACL) injuries are common in adolescents and its prevalence has increased over the years, especially with more adolescents engaging in physical activities and competitive sports. Standard of care for these injuries would be an ACL reconstruction (ACLR) to allow return to function and sports and reduce the risk of post-traumatic arthritis and recurrent knee injuries. Rehabilitation post-ACLR is crucial to optimise surgical outcomes and prevent re-rupture of ACL. However, good compliance to rehabilitation is often a challenge for patients and healthcare providers.

Telerehabilitation for this group of patients may help to augment rehabilitation by improving patient compliance and overcome barriers to behavioural change often observed in traditional in-person physiotherapy. It can also allow remote monitoring and provide feedback to patients during exercises. In addition, it is a useful tool during pandemic when in-person visits are not possible. Currently, very few studies have evaluated the use of telerehabilitation with remote monitoring for ACLR, especially in adolescents. The use of home-based telerehabilitation post ACLR may be key to improving patient motivation and exercise compliance in adolescents.

For this pilot study, the intervention group will undergo the TAR program in addition to standard care, which involves self-administered exercises in initial 12 weeks post ACLR using a mobile application. The mobile application will detect key landmarks on the body for human pose estimation. Participants will be able to perform their exercises with real-time feedback given, allowing for proper execution of the exercises. Exercise adherence, range of motion and pain scores will be tracked via the application and therapists are able to monitor via the online dashboard. The control group will undergo standard in-person physiotherapy.

Primary aim of this study is to examine exercise adherence in TAR program versus standard care post ACLR in adolescents. Secondary aims of this study are to examine the effects of TAR program on knee strength, range, function, quality of life, treatment satisfaction, self-determination and number of face-to-face rehabilitation sessions required after ACLR.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore
        • Recruiting
        • KK Women's and Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants age 12 to 20 years old
  • Participants undergoing ACLR surgery
  • Participants willing to be included in either the intervention group (utilizing the mobile application) or control group

Exclusion Criteria:

  • Participants with complications after ACLR surgery
  • Participants with significant neurological or other lower limb impairments or conditions affecting mobility and function
  • Participants with previous ACL surgeries of the same affected lower limb
  • Participants with previous surgeries or trauma to the unaffected lower limb

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telerehabilitation TAR program using a mobile application (intervention group)
Participants in the intervention group will undergo the telerehabilitation TAR program and install and utilise the application on their mobile device, and self-administer the home exercises as prescribed by their physiotherapists. The mobile application uses novel deep learning algorithm on a mobile platform to detect key landmarks on the body for human pose estimation. Participants will be able to perform their rehabilitation exercise with real-time feedback allowing for proper execution of the exercises. The participants will be instructed on the installation and use of the mobile application and will be expected to perform the prescribed exercises independently (using the application) as instructed by their Physiotherapists. This application will be used for the initial 12 weeks of post-op rehabilitation.
Device: Telerehabilitation TAR program using a mobile application
Participants in this study arm will use a mobile application which allows participants to perform their home exercises with real-time feedback given, allowing for proper execution of exercises, on top of standard care.
Active Comparator: Standard rehabilitation (control group)
Participants in the control group will attend standard in person rehabilitation sessions at the outpatient clinic. Participants will be prescribed a home exercise program as per standard care.
Other: Standard rehabilitation sessions
Participants in this control group will attend standard in person rehabilitation sessions with home exercise program given as per standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise adherence
Time Frame: Post-operatively: Week 3, Week 6, Week 9, Week 12
This will be measured via the Exercise Adherence Rating Scale (via the 6 item questions on assessing adherence to prescribed home exercises) over 12 weeks post-operatively, via changes in scores over the time points. The scores will range from 0-24, with higher scores indicating higher adherence.
Post-operatively: Week 3, Week 6, Week 9, Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: Pre-operatively (≤one month prior to operation), Post-operatively: Week 3, Week 6, Week 9, Week 12
Pain at rest and with movement will be measured on a 11-point numeric pain rating scale, with zero representing no pain at all and 10 representing worst imaginable pain.
Pre-operatively (≤one month prior to operation), Post-operatively: Week 3, Week 6, Week 9, Week 12
Range of motion
Time Frame: Pre-operatively (≤one month prior to operation), Post-operatively: Week 3, Week 6, Week 9, Week 12
A goniometer will be used to measure knee range of motion.
Pre-operatively (≤one month prior to operation), Post-operatively: Week 3, Week 6, Week 9, Week 12
Quadriceps and hamstring strength
Time Frame: Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
Strength for quadriceps and hamstring will be obtained using the knee flexion extension machine (isotonic isometric).
Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
One leg sit to stand
Time Frame: Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
One leg sit to stand test will be conducted with a standard chair height, with one leg sit to stand rate calculated.
Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
Self-reported function
Time Frame: Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
Pedi-IKDC (Pediatric version of the International Knee Documentation Committee) questionnaire will be used to measure their self-reported lower limb function (scores range from 0-100, with higher scores indicating lower function or greater symptoms).
Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
Self-reported quality of life
Time Frame: Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12

EQ-5D-Y (child-friendly EQ-5D version) quality of life questionnaire consists of two sections. First section covers five health domains: mobility, self-care, usual activities, pain or discomfort and feeling worried, sad or unhappy, with each domain responses as no problems, some problems and a lot of problems. The response categories will be reflected by a 1-digit number (1-3) and combined into a 5-digit number based on the domains to describe their health state.

The second section cover the EQ VAS, which requires rating of their health between 100 (the best health you can imagine) and 0 (the worst health you can imagine).
Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
Motivation
Time Frame: Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
Treatment self-regulation questionnaire will be used to measure their self-determination/ motivation to exercise regularly. It consists of 15 questions on a 7-point scale from 'not at all true' to 'very true'. Scores for each question range from 1 to 7, with higher scores indicating the more dominant motivational style.
Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
Perceived competence
Time Frame: Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
Perceived competence scale will be used to measure their perceived confidence to exercise regularly. It consists of four questions on a 7-point scale from 'not at all true' to 'very true'. Total scores range from 4 to 28, with higher scores indicating greater perceived confidence.
Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
Treatment satisfaction
Time Frame: Post-operatively: Week 6, Week 12
A 11-point numeric rating scale will be used for participants to rate their satisfaction and convenience of treatment received, with zero indicating not satisfied at all/ not convenient at all and 10 indicating completely satisfied/ most convenient.
Post-operatively: Week 6, Week 12
Number of face to face rehabilitation session
Time Frame: Post-operatively: Week 12
Number of in person rehabilitation sessions
Post-operatively: Week 12
mHealth App Usability Questionnaire (MAUQ)
Time Frame: Post-operatively: Week 12
This will be used with participants in the intervention group to gather feedback and determine usability of the use of this mobile application for home-based rehabilitation post ACLR. Each survey question consists of a Likert scale rating (on a scale of five), with higher scores indicating greater ease of use and satisfaction, system information arrangement, usefulness and intention to use.
Post-operatively: Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KK Women's and Children's Hospital

Investigators

  • Principal Investigator: Siao Hui Toh, PhD, KK Women's and Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2023

Primary Completion (Anticipated)

October 31, 2024

Study Completion (Anticipated)

April 30, 2025

Study Registration Dates

First Submitted

February 10, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

April 5, 2023

Study Record Updates

Last Update Posted (Actual)

April 5, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/2379

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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