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

Not Applicable

Recruiting

• Conditions: Anterior Cruciate Ligament Reconstruction
• Interventions: Behavioral: the traditional rehabilitation group; Device: the remote rehabilitation group

• Registration Number: NCT06327555
• Lead Sponsor: Peking University Third Hospital

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2023-09
• Study Start: 2023-09-01
• Study First Submitted: 2024-03-17
• Study First Submitted QC: 2024-03-17
• Study First Posted: 2024-03-25
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

1. Adults (18-65 years old) with unilateral initial ACL rupture;
2. have a mobile device (e.g., smartphone or tablet) that can connect to the Internet;
3. be able to use mobile applications;
4. be able to complete the plan and related follow-up three weeks before admission or within 3 months after discharge;
5. be able to communicate with researchers in Chinese (Mandarin);
6. Ability to provide informed and valid consent to participate in the study

Read More

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 the last 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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the traditional rehabilitation group	the traditional rehabilitation group	The traditional rehabilitation group takes a face-to-face approach, with therapists providing outpatient rehabilitation instruction twice a week for six weeks.
the remote rehabilitation group	the remote rehabilitation group	The remote rehabilitation group uses software and sensors to provide remote postoperative rehabilitation guidance.

Primary Outcome Measures

Name	Time	Method
knee Isokinetic strength	six months after ACL reconstruction	knee strength
the Lysholm Knee Scoring Scale	six months after ACL reconstruction	the Lysholm Knee Scoring Scale

Secondary Outcome Measures

Name	Time	Method
Y-balance balance test	six months after ACL reconstruction	Y-balance balance test score
Tegner score	six months after ACL reconstruction	Tegner score
the 36-item Short Form Health Survey(SF-36)	six months after ACL reconstruction	the 36-item Short Form Health Survey(SF-36) score

Trial Locations

Locations (1)

quan Jian Wang; 🇨🇳 Beijing, Beijing, China