Tele-rehabilitation After Anterior Cruciate Ligament Reconstruction (tele-rehab)

Kexin Wang, MM

Status: Not yet enrolling

Conditions: Anterior Cruciate Ligament Reconstruction; Tele-rehabilitation

Treatments: Behavioral: Tele-rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06232824

WestChinaH20240116

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

Intervention

Experimental group

Description:

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).

Treatment:

Behavioral: Tele-rehabilitation

Control

No Intervention group

Description:

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. At the 2, 4, 8, 12, and 24 weeks after ACLR, all participants went to the outpatient clinic for follow-up by physiotherapist to provide face-to-face guidance for exercise methods. Physiotherapist would clarify the content of the rehabilitation plan if any doubt, but will not provide information extending the prearranged scope.