Tele-rehabilitation After Anterior Cruciate Ligament Reconstruction

Anterior Cruciate Ligament Reconstruction Clinical Trial

— tele-rehab  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06232824
• Other study ID #: WestChinaH20240116
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: West China Hospital
• Contact: Kexin Wang, MM
• Phone: +86 15881189695
• Email: wangkexin3[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Reconstruction

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kexin Wang, MM

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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