Telerehabilitation for Anterior Cruciate Ligament Reconstruction - TAR Program in Adolescents

NCT ID: NCT05799235

Last Updated: 2023-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Telerehabilitation Anterior Cruciate Ligament Injuries Anterior Cruciate Ligament

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Telerehabilitation TAR program using a mobile application

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

Standard rehabilitation sessions

Intervention Type OTHER

Participants in this control group will attend standard in person rehabilitation sessions with home exercise program given as per standard care.

Interventions

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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.

Intervention Type DEVICE

Standard rehabilitation sessions

Participants in this control group will attend standard in person rehabilitation sessions with home exercise program given as per standard care.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KK Women's and Children's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Siao Hui Toh

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Siao Hui Toh, PhD

Role: PRINCIPAL_INVESTIGATOR

KK Women's and Children's Hospital

Locations

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KK Women's and Children's Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Cheri Chan

Role: CONTACT

+65 6225 5554

Other Identifiers

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2022/2379

Identifier Type: -

Identifier Source: org_study_id

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