Study on the Effect of Telerehabilitation Using Wearable Devices After ACL Reconstruction

Anterior Cruciate Ligament Reconstruction Clinical Trial

Official title: The Impact of a Novel AI-based Remote Rehabilitation Platform on Functional Outcomes, Psychological Outcomes After Treatment of Anterior Cruciate Ligament Reconstruction Compared With Traditional Clinical Rehabilitation

Status Recruiting

Clinical Trial Summary

Trial purpose: To evaluate the safety and effectiveness of using a new remote rehabilitation platform for postoperative rehabilitation in patients with anterior cruciate ligament rupture compared to conventional rehabilitation care through a randomized controlled trial.

Test subjects: This study is a multicenter study that recruited 252 participants from three centers (aged ≥ 18 years) for cruciate ligament rupture reconstruction; Exclude patients who have undergone revision and bilateral surgery, and exclude patients with collateral ligament and posterior cruciate ligament injuries in the knee joint.

Trial plan: The subjects were randomly enrolled and randomly divided into two groups: the remote rehabilitation group and the traditional rehabilitation group, using a mixed block randomization method. The probability of being divided into both groups was 50%. All subjects received routine outpatient diagnosis and treatment, with the same content. The remote rehabilitation group uses software and sensors to provide remote postoperative rehabilitation guidance. The traditional rehabilitation group receives routine rehabilitation diagnosis and treatment, with face-to-face rehabilitation twice a week. All subjects are required to undergo regular follow-up (1 day before surgery, 3 months after surgery, 6 months).

Outcome measures: The main outcome measures were knee isokinetic muscle strength and Lysholm knee joint score . the secondary outcome measures were Y-balance test, Tegner activity scale, health survey summary table (SF-36),The other outcome measures were Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) Scale, vas pain score.

Clinical Trial Description

Trial purpose: To evaluate the safety and effectiveness of using a new remote rehabilitation platform for postoperative rehabilitation in patients with anterior cruciate ligament rupture compared to conventional rehabilitation care through a randomized controlled trial.

Test subjects: This study is a multicenter study that recruited 252 participants from three centers (aged ≥ 18 years) for cruciate ligament rupture reconstruction; Inclusion Criteria

1) adults with unilateral initial ACL rupture (greater than or equal to 18 years of age), 2) have a mobile device (e.g., smartphone or tablet) that can connect to the Internet, 3) Ability to use mobile applications, 4) be able to complete the plan and related follow-up within 3 months after discharge, 5) be able to communicate with researchers in Chinese (Mandarin), 6) Be able to provide informed and valid consent to participate in the study. Exclusion criteria

1. Undergoing revision and bilateral surgery;

2. concomitant health conditions that are likely to interfere with rehabilitation exercises, such as severe visual impairment or blindness; Grade II or above heart failure according to the New York Heart Association;

3. Have undergone other lower extremity surgery within at least 6 months or will undergo lower extremity surgery again within 3 months;

4. Structural injuries such as collateral ligament and posterior cruciate ligament in the knee joint;

5. Combined with knee joint infection, fracture, tumor, etc.;

6. There are serious postoperative complications, such as incision infection, venous thromboembolism, etc.

7. Acute surgery.

Trial plan: The subjects were randomly enrolled and randomly divided into two groups: the remote rehabilitation group and the traditional rehabilitation group, using a mixed block randomization method. The probability of being divided into both groups was 50%. The trial was divided into 3 phases, including before surgery, 3-month review, 6-month review. After each stage, the patient will undergo a knee function assessment, and the doctor will provide a rehabilitation plan based on this.All subjects received routine outpatient diagnosis and treatment, with the same content. The remote rehabilitation group uses software and sensors to provide remote postoperative rehabilitation guidance. The traditional rehabilitation group receives routine rehabilitation diagnosis and treatment, with face-to-face rehabilitation twice a week. All subjects are required to undergo regular follow-up (1 day before surgery, 3 months after surgery, 6 months).

Outcome measures: The main outcome measures were knee isokinetic muscle strength and Lysholm knee joint score . the secondary outcome measures were Y-balance balance test, Tegner activity scale, health survey summary table (SF-36),The other outcome measures were Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) Scale, vas pain score. ;

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

• NCT number: NCT06327555
• Study type: Interventional
• Source: Peking University Third Hospital
• Contact: quan J Wang, M.D.
• Phone: 13801076267
• Email: wjqsportsmed@163.com
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Completion date: June 30, 2025