Clinical trial NCT06232824: Tele-rehabilitation After Anterior Cruciate Ligament Reconstruction
Official title: Multicomponent Supervised Tele-rehabilitation Versus Home-based Self-rehabilitation After Anterior Cruciate Ligament Reconstruction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tele-rehabilitation
Anterior Cruciate Ligament Reconstruction
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention 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.

Control Participants in the control group could only receive a graphic and textual minimal postoperative rehabilitation plan on the mobile phone application. However, the participants was not informed the frequency and intensity of the rehabilitation items. They could not communicate with therapists online. Participants in the control group was expected to exercise unsupervised postoperatively.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: the percentage of patients who achieve a satisfactory active ROM (flexion and extension)
timeFrame: at the 2, 4, 8, 12 and 24 weeks following the ACLR
Secondary outcomes:
measure: active and passive ROM
timeFrame: at the 2, 4, 8, 12 and 24 weeks following the ACLR
measure: Visual analogue scale (VAS)
timeFrame: at the 2, 4, 8, 12 and 24 weeks following the ACLR
measure: Muscle strength
timeFrame: at the 2, 4, 8, 12 and 24 weeks following the ACLR
measure: The 2000 International Knee Documentation Committee (IKDC)
timeFrame: at the 2, 4, 8, 12 and 24 weeks following the ACLR
measure: knee injury and osteoarthritis outcome score (KOOS)
timeFrame: at the 2, 4, 8, 12 and 24 weeks following the ACLR
measure: the Tegner activity scale
timeFrame: at the 2, 4, 8, 12 and 24 weeks following the ACLR
measure: the Lysholm knee scoring scale
timeFrame: at the 2, 4, 8, 12 and 24 weeks following the ACLR
Other outcomes:
Locations:
Study officials:
References: