TelerehabilitationTARNCT05799235
Telerehabilitation for Anterior Cruciate Ligament Reconstruction - TAR Program in Adolescents
A study testing Telerehabilitation TAR program using a mobile application and Standard rehabilitation sessions in people with Telerehabilitation and Anterior Cruciate Ligament Injuries, run by KK Women's and Children's Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Telerehabilitation, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament
- What is being tested?
- Telerehabilitation TAR program using a mobile application and Standard rehabilitation sessions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Feb 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore
About this study
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
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.
Read more
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.
- Being tested
- Telerehabilitation TAR program using a mobile application, Standard rehabilitation sessions
- Keywords
- Telerehabilitation, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Reconstruction, Mobile application, Adolescent
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehabilitation TAR program using a mobile applicationDevice
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 sessionsOther
Participants in this control group will attend standard in person rehabilitation sessions with home exercise program given as per standard care.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation TAR program using a mobile application (intervention group) | Experimental | 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. Receives: Device: Telerehabilitation TAR program using a mobile application |
| Standard rehabilitation (control group) | Active comparator | 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. Receives: Other: Standard rehabilitation sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-operatively: Week 3, Week 6, Week 9, Week 12
Secondary outcomes (11)
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.
Measured: Pre-operatively (≤one month prior to operation), Post-operatively: Week 3, Week 6, Week 9, Week 12
Range of motion
A goniometer will be used to measure knee range of motion.
Measured: Pre-operatively (≤one month prior to operation), Post-operatively: Week 3, Week 6, Week 9, Week 12
Quadriceps and hamstring strength
Strength for quadriceps and hamstring will be obtained using the knee flexion extension machine (isotonic isometric).
Measured: Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
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.
Measured: Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
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).
Measured: Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
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).
Measured: Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
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.
Measured: Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
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.
Measured: Pre-operatively (≤one month prior to operation), Post-operatively: Week 6, Week 12
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.
Measured: Post-operatively: Week 6, Week 12
Number of face to face rehabilitation session
Number of in person rehabilitation sessions
Measured: Post-operatively: Week 12
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.
Measured: Post-operatively: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start15 Feb 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelerehabilitationStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Siao Hui Toh, KK Women's and Children's Hospital
- Investigators
- Siao Hui Toh, PhD, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05799235
- Sponsor's protocol ID
- 2022/2379
- Acronym
- TAR
- Status last verified
- Mar 2023
- First submitted
- 10 Feb 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05799235
- Acronym / sponsor ID
- TAR / 2022/2379
- Keywords
- Telerehabilitation, Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Reconstruction, Mobile application, Adolescent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation TAR program using a mobile application (intervention group) | Experimental | Device: Telerehabilitation TAR program using a mobile applicationParticipants 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 comparator | Other: Standard rehabilitation sessionsParticipants 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. |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehabilitation TAR program using a mobile applicationParticipants 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. | Device | Telerehabilitation TAR program using a mobile application (intervention group) |
| Standard rehabilitation sessionsParticipants in this control group will attend standard in person rehabilitation sessions with home exercise program given as per standard care. | Other | Standard rehabilitation (control group) |
Primary outcome
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.
11 secondary outcomes
Pain intensity
Time frame: 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
Quadriceps and hamstring strength
Time frame: 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
Self-reported function
Time frame: 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
Motivation
Time frame: 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
Treatment satisfaction
Time frame: Post-operatively: Week 6, Week 12
Number of face to face rehabilitation session
Time frame: Post-operatively: Week 12
mHealth App Usability Questionnaire (MAUQ)
Time frame: Post-operatively: Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siao Hui Toh, PhD principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation TAR program using a mobile application and Standard rehabilitation sessions in people with Telerehabilitation and Anterior Cruciate Ligament Injuries, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cheri Chan (+65 6225 5554, cheri.chan.s.h@kkh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise adherence (time frame: Post-operatively: Week 3, Week 6, Week 9, Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.