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

Primary Purpose

Telerehabilitation, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Telerehabilitation TAR program using a mobile application
Standard rehabilitation sessions
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Telerehabilitation focused on measuring Telerehabilitation, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Reconstruction, Mobile application, Adolescent

Eligibility Criteria

12 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • KK Women's and Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telerehabilitation TAR program using a mobile application (intervention group)

Standard rehabilitation (control group)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Exercise adherence
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.

Secondary Outcome Measures

Pain intensity
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.
Range of motion
A goniometer will be used to measure knee range of motion.
Quadriceps and hamstring strength
Strength for quadriceps and hamstring will be obtained using the knee flexion extension machine (isotonic isometric).
One leg sit to stand
One leg sit to stand test will be conducted with a standard chair height, with one leg sit to stand rate calculated.
Self-reported function
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).
Self-reported quality of life
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).
Motivation
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.
Perceived competence
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.
Treatment satisfaction
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.
Number of face to face rehabilitation session
Number of in person rehabilitation sessions
mHealth App Usability Questionnaire (MAUQ)
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.

Full Information

First Posted
February 10, 2023
Last Updated
March 22, 2023
Sponsor
KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05799235
Brief Title
Telerehabilitation for Anterior Cruciate Ligament Reconstruction - TAR Program in Adolescents
Acronym
TAR
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KK Women's and Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telerehabilitation, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament
Keywords
Telerehabilitation, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Reconstruction, Mobile application, Adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telerehabilitation TAR program using a mobile application (intervention group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard rehabilitation (control group)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Telerehabilitation TAR program using a mobile application
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard rehabilitation sessions
Intervention Description
Participants in this control group will attend standard in person rehabilitation sessions with home exercise program given as per standard care.
Primary Outcome Measure Information:
Title
Exercise adherence
Description
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.
Time Frame
Post-operatively: Week 3, Week 6, Week 9, Week 12
Secondary Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
Pre-operatively (≤one month prior to operation), Post-operatively: Week 3, Week 6, Week 9, Week 12
Title
Range of motion
Description
A goniometer will be used to measure knee range of motion.
Time Frame
Pre-operatively (≤one month prior to operation), Post-operatively: Week 3, Week 6, Week 9, Week 12
Title
Quadriceps and hamstring strength
Description
Strength for quadriceps and hamstring will be obtained using the knee flexion extension machine (isotonic isometric).
Time Frame
Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
Title
One leg sit to stand
Description
One leg sit to stand test will be conducted with a standard chair height, with one leg sit to stand rate calculated.
Time Frame
Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
Title
Self-reported function
Description
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).
Time Frame
Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
Title
Self-reported quality of life
Description
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).
Time Frame
Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
Title
Motivation
Description
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.
Time Frame
Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
Title
Perceived competence
Description
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.
Time Frame
Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
Title
Treatment satisfaction
Description
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.
Time Frame
Post-operatively: Week 6, Week 12
Title
Number of face to face rehabilitation session
Description
Number of in person rehabilitation sessions
Time Frame
Post-operatively: Week 12
Title
mHealth App Usability Questionnaire (MAUQ)
Description
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.
Time Frame
Post-operatively: Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheri Chan
Phone
+65 6225 5554
Email
cheri.chan.s.h@kkh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siao Hui Toh, PhD
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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Telerehabilitation for Anterior Cruciate Ligament Reconstruction - TAR Program in Adolescents

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