Tele-rehabilitation After Anterior Cruciate Ligament Reconstruction

NCT06232824 | Not Yet Recruiting

• 1 other identifier: WestChinaH20240116
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tele-rehabilitation; Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (1)

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

  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.

  at the 2, 4, 8, 12 and 24 weeks following the ACLR

Secondary Outcomes (7)

• active and passive ROM

  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

• Muscle strength

  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

Study Arms (2)

Intervention

EXPERIMENTAL

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).

Behavioral: Tele-rehabilitation

Control

NO INTERVENTION

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.

Interventions

Tele-rehabilitation BEHAVIORAL

The whole program is constituted of preoperative education and postoperative rehabilitation (in hospital and out of hospital). All the participants received the same preoperative education through the mobile phone application and oral communication. Participants in the intervention group get the multicomponent supervised tele-rehabilitation, while participants in the control group get the home-based self-rehabilitation. All the postoperative rehabilitation programs are presented and executed through the mobile phone application.

Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Kexin Wang, MM: lead

Related Publications (1)

• Wang K, Peng L, You M, Deng Q, Li J. Multicomponent supervised tele-rehabilitation versus home-based self-rehabilitation management after anterior cruciate ligament reconstruction: a study protocol for a randomized controlled trial. J Orthop Surg Res. 2024 Jun 28;19(1):381. doi: 10.1186/s13018-024-04871-0.

  PMID: 38943178 DERIVED

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Central Study Contacts

Kexin Wang, MM

CONTACT

+86 15881189695; wangkexin3@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinded participants and therapists were not implemented in our study. Before the intervention, an independent researcher communicated with the patient to inform the method of using the mobile application. Apart from the mobile application, no paper rehabilitation program materials will be distributed to participants. Admission, ACLR surgery, follow-up, and assessment of all participants were conducted separately and will not be arranged in the same ward room to avoid discussion and communication between participants. The ACLR surgery was performed by a senior surgeon who was blinded to the group allocation. In addition, we selected two assessors who were blinded to the group allocation to measure the baseline data and follow-up outcomes after the intervention. The collection and analysis of data were carried out by two independent researchers who were also blinded to the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 31, 2024
• Study Start: March 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share