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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anterior Cruciate Ligament Reconstruction; Tele-rehabilitation
• Intervention / Treatment: Behavioral: Tele-rehabilitation

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kexin Wang, MM; Phone Number: +86 15881189695; Email: wangkexin3@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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. 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; 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.
No Intervention: 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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kexin Wang, MM

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: WestChinaH20240116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No