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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06327555
• Other study ID #: M2023132
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: September 2023
• Source: Peking University Third Hospital
• Contact: quan J Wang, M.D.
• Phone: 13801076267
• Email: wjqsportsmed[@]163.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

Behavioral:
• 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.

Device:
• the remote rehabilitation group
The telerehabilitation group uses smart wearables and mobile apps worn around the knee joint to perform remote rehabilitation at home. At least twice a week, both sets of training sessions are identical.

Locations

Country	Name	City	State
China	quan Jian Wang	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) Scale	Anterior Cruciate Ligament Return to Sport After Injury Scale	six months after ACL reconstruction
Other	VAS pain score	VAS pain score	six months after ACL reconstruction
Primary	the Lysholm Knee Scoring Scale	the Lysholm Knee Scoring Scale	six months after ACL reconstruction
Primary	knee Isokinetic strength	knee strength	six months after ACL reconstruction
Secondary	Y-balance balance test	Y-balance balance test score	six months after ACL reconstruction
Secondary	Tegner score	Tegner score	six months after ACL reconstruction
Secondary	the 36-item Short Form Health Survey(SF-36)	the 36-item Short Form Health Survey(SF-36) score	six months after ACL reconstruction