Tele-rehabilitation After Anterior Cruciate Ligament Reconstruction

Not Applicable

Not yet recruiting

• Conditions: Tele-rehabilitation; Anterior Cruciate Ligament Reconstruction
• Interventions: Behavioral: Tele-rehabilitation

• Registration Number: NCT06232824
• Lead Sponsor: Kexin Wang, MM

Brief Summary

The investigators aims to evaluate the effect of multicomponent supervised tele-rehabilitation, compared to home-based self-rehabilitation, on range of motion (ROM), pain, muscle strength, and function in patients following ACLR. The hypothesis is of superiority for the effects of multicomponent supervised tele-rehabilitation over home-based self-rehabilitation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-30
• Last Update Submitted: 2024-01-30
• Study First Posted: 2024-01-31
• Last Update Posted: 2024-01-31
• Study Start: 2024-03-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Aged between 18 and 50 years at the time of recruit;
2. BMI between 16 and 28 kg/m²;
3. acute unilateral ACL rupture;
4. plan for an ACLR surgery (with autologous hamstrings tendon reconstruction) under arthroscopy;
5. ACL rupture to ACLR within 3 months;
6. Patients can independently use mobile software and WeChat mini programs, and can operate related software through the "Huajiantong" mini program under the guidance of staff;

Exclusion Criteria

1. With synthetic tendon reconstruction;
2. Concomitant meniscus lesion which needs operation;
3. Concomitant other ligaments injury which needs operation;
4. Concomitant intra-articular knee fracture;
5. Concomitant fracture or injury which may affect postoperative exercise;
6. Previous history of knee infection, fracture, and surgery;
7. Participate in knee exercises and/or rehabilitation programs in the past three months;
8. Living outside the city, regular return to the hospital for follow-up cannot be guaranteed;
9. Serious cardiopulmonary disease and unable to participate in rehabilitation exercise;
10. Other reasons for exclusion (mental disorders, stroke, pregnancy, etc).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Tele-rehabilitation	Participants in the intervention group coud only view the rehabilitation content that needs to be carried out at the current phase every day and confirm whether to execute it on the application. Participants could communicate with therapists on the mobile phone application by sending text, voice, images, and videos throughout the entire experiment. Participants in the intervention group received detailed education and rehabilitation program on the mobile phone application including text, photos, and videos. On the first day of enrollment, the doctor inform the participants of the importance of rehabilitation and how to use the mobile phone application. The postoperative rehabilitation protocol includes four phases: Phase 1 (0-2 weeks), Phase 2 (3-4 weeks), Phase 3 (5-8 weeks), Phase 4 (9-12 weeks), and Phase 5 (after 13 weeks).

Primary Outcome Measures

Name	Time	Method
the percentage of patients who achieve a satisfactory active ROM (flexion and extension)	at the 2, 4, 8, 12 and 24 weeks following the ACLR	In the first 3 months after ACLR, the achievement of acceptable knee active extension and flexion was regarded as what matters most for a successful recovery. A good knee active ROM could guarantee an expectedly continue improvement.

Secondary Outcome Measures

Name	Time	Method
active and passive ROM	at the 2, 4, 8, 12 and 24 weeks following the ACLR	The active and passive ROM of the affected side knee
the Lysholm knee scoring scale	at the 2, 4, 8, 12 and 24 weeks following the ACLR	The Lysholm Knee Score is a questionnaire consisting of 8 items that the patient completes together with the therapist. The questionnaire is designed to assess the degree of knee instability at both impairment and limitation levels. .The Lysholm Knee Score calculates and grades an overall score from 0 to 100 based on 8 domains: squatting, locking, pain, stair climbing, support, instability, and edema.A higher score mean a better outcome. Scores between 95 and 100 are regarded as exceptional, 84 and 94 as acceptable, 65 to 83 as fair, and less than 65 as poor.
Muscle strength	at the 2, 4, 8, 12 and 24 weeks following the ACLR	The isokinetic concentric strength test was used to assess muscle strength. Isokinetic concentric extenso was the best rated with sufficient intrarater reliability and construct validity for the measurement of knee muscle strength
the Tegner activity scale	at the 2, 4, 8, 12 and 24 weeks following the ACLR	the Tegner activity scale is a one-item questionnaire that is scored on an 11-item scale (0 to 10) based on the patient's reported level of activity/work. A level of 0 represents maximum disability while a level of 10 represents elite sports athletes.
Visual analogue scale (VAS)	at the 2, 4, 8, 12 and 24 weeks following the ACLR	The postoperative pain was measured with VAS. The VAS scale ranges from 0 to 10 points, 0 points represent no pain, while 10 points represent the worst imaginable pain. A higher VAS score mean a worse outcome.
knee injury and osteoarthritis outcome score (KOOS)	at the 2, 4, 8, 12 and 24 weeks following the ACLR	The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL).Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
The 2000 International Knee Documentation Committee (IKDC)	at the 2, 4, 8, 12 and 24 weeks following the ACLR	The 2000 International Knee Documentation Committee (IKDC) Subjective Knee Form is a patient-oriented questionnaire that assesses symptoms and function in daily living activities. Scores are obtained by summing the individual items and then transforming the crude total to a scaled number that ranges from 0 to 100. This final number is interpreted as a measure of function with higher scores representing higher levels of function.