Telerehabilitation for Anterior Cruciate Ligament Reconstruction - TAR Program in Adolescents
TAR
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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2023
CompletedStudy Start
First participant enrolled
February 15, 2023
CompletedFirst Posted
Study publicly available on registry
April 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedApril 5, 2023
March 1, 2023
1.7 years
February 10, 2023
March 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Post-operatively: Week 3, Week 6, Week 9, Week 12
Secondary Outcomes (11)
Pain intensity
Pre-operatively (≤one month prior to operation), Post-operatively: Week 3, Week 6, Week 9, Week 12
Range of motion
Pre-operatively (≤one month prior to operation), Post-operatively: Week 3, Week 6, Week 9, Week 12
Quadriceps and hamstring strength
Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
One leg sit to stand
Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
Self-reported function
Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
- +6 more secondary outcomes
Study Arms (2)
Telerehabilitation TAR program using a mobile application (intervention group)
EXPERIMENTALParticipants 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.
Standard rehabilitation (control group)
ACTIVE COMPARATORParticipants 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.
Interventions
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.
Participants in this control group will attend standard in person rehabilitation sessions with home exercise program given as per standard care.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
KK Women's and Children's Hospital
Singapore, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Siao Hui Toh, PhD
KK Women's and Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 10, 2023
First Posted
April 5, 2023
Study Start
February 15, 2023
Primary Completion
October 31, 2024
Study Completion
April 30, 2025
Last Updated
April 5, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share