Multicomponent Supervised Tele-rehabilitation Versus Home-based Self-rehabilitation After Anterior Cruciate Ligament Reconstruction

Kexin Wang, MM0 sites110 target enrollmentMarch 1, 2024

ConditionsTele-rehabilitation Anterior Cruciate Ligament Reconstruction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Tele-rehabilitation
Sponsor: Kexin Wang, MM
Enrollment: 110
Primary Endpoint: the percentage of patients who achieve a satisfactory active ROM (flexion and extension)
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 1, 2024

End Date

December 31, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kexin Wang, MM

Responsible Party

Sponsor Investigator

Principal Investigator

Kexin Wang, MM

Clinical Professor

West China Hospital

Eligibility Criteria

Inclusion Criteria

•Aged between 18 and 50 years at the time of recruit;
•BMI between 16 and 28 kg/m²;
•acute unilateral ACL rupture;
•plan for an ACLR surgery (with autologous hamstrings tendon reconstruction) under arthroscopy;
•ACL rupture to ACLR within 3 months;
•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

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

Outcomes

Primary Outcomes

the percentage of patients who achieve a satisfactory active ROM (flexion and extension)

Time Frame: 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 Outcomes

the Lysholm knee scoring scale(at the 2, 4, 8, 12 and 24 weeks following the ACLR)
active and passive ROM(at the 2, 4, 8, 12 and 24 weeks following the ACLR)
Muscle strength(at the 2, 4, 8, 12 and 24 weeks following the ACLR)
the Tegner activity scale(at the 2, 4, 8, 12 and 24 weeks following the ACLR)
Visual analogue scale (VAS)(at the 2, 4, 8, 12 and 24 weeks following the ACLR)
The 2000 International Knee Documentation Committee (IKDC)(at the 2, 4, 8, 12 and 24 weeks following the ACLR)
knee injury and osteoarthritis outcome score (KOOS)(at the 2, 4, 8, 12 and 24 weeks following the ACLR)