Clinical trial NCT06327555: Study on the Effect of Telerehabilitation Using Wearable Devices After ACL Reconstruction
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Peking University First Hospital
First posted: 2024-03-25
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 recruited 216 participants (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 recruited 216 participants (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.

Eligibility criteria: 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

Primary outcomes:
measure: the Lysholm Knee Scoring Scale
timeFrame: six months after ACL reconstruction
measure: knee Isokinetic strength
timeFrame: six months after ACL reconstruction
Secondary outcomes:
measure: Y-balance balance test
timeFrame: six months after ACL reconstruction
measure: Tegner score
timeFrame: six months after ACL reconstruction
measure: the 36-item Short Form Health Survey(SF-36)
timeFrame: six months after ACL reconstruction
Other outcomes:
measure: Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) Scale
timeFrame: six months after ACL reconstruction
measure: VAS pain score
timeFrame: six months after ACL reconstruction
Locations:
city: Beijing
country: China
facility: quan Jian Wang
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: quan J Wang, M.D.
role: STUDY_CHAIR
References: