Clinical trial NCT05799235: Telerehabilitation for Anterior Cruciate Ligament Reconstruction - TAR Program in Adolescents
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
Overall status: UNKNOWN
Phase: NA
Conditions: Telerehabilitation
Anterior Cruciate Ligament Injuries
Anterior Cruciate Ligament
Keywords: Telerehabilitation
Anterior Cruciate Ligament Injuries
Anterior Cruciate Ligament Reconstruction
Mobile application
Adolescent
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2023-04-05
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Exercise adherence
timeFrame: Post-operatively: Week 3, Week 6, Week 9, Week 12
Secondary outcomes:
measure: Pain intensity
timeFrame: Pre-operatively (≤one month prior to operation), Post-operatively: Week 3, Week 6, Week 9, Week 12
measure: Range of motion
timeFrame: Pre-operatively (≤one month prior to operation), Post-operatively: Week 3, Week 6, Week 9, Week 12
measure: Quadriceps and hamstring strength
timeFrame: Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
measure: One leg sit to stand
timeFrame: Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
measure: Self-reported function
timeFrame: Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
measure: Self-reported quality of life
timeFrame: Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
measure: Motivation
timeFrame: Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
measure: Perceived competence
timeFrame: Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
measure: Treatment satisfaction
timeFrame: Post-operatively: Week 6, Week 12
measure: Number of face to face rehabilitation session
timeFrame: Post-operatively: Week 12
measure: mHealth App Usability Questionnaire (MAUQ)
timeFrame: Post-operatively: Week 12
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Siao Hui Toh, PhD
role: PRINCIPAL_INVESTIGATOR
References: