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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05254054
Other study ID # 2019.432
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date December 1, 2025

Study information

Verified date August 2023
Source Chinese University of Hong Kong
Contact Xin He, PhD
Phone 68102694
Email xinhe@cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomised clinical trial to detect the effect of an 8-week whole body vibration training on muscle function and dynamic knee function during single leg squat and single leg hop in patients after anterior cruciate ligament reconstruction


Description:

In Hong Kong, over 3000 cases of ACL reconstruction are operated annually to restore knee stability. Despite recovery of knee passive laxity and muscle strength, dynamic knee stability is often not restored. The whole body vibration has been found to improve muscle strength, proprioception and balance after ACL reconstruction. This project will investigate the effect of whole body vibration on muscle elasticity, muscle coordination and landing knee biomechanics. It may provide useful evidence to the application of whole body vibration in improving dynamic knee stability, which will lead to a significant improvement in healthcare management for ACL patients . The current study serves to provide a clinical guideline for post-ACL reconstruction rehabilitation.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: 1. Aged 18-50; 2. Physically active before injury with Tegner score more than 6 (recreational/professional sport level); 3. Scheduled for ACLR because of sport injury; 4. Be able to walk with a pair of elbow crutches independently at 1 month after ACLR. Exclusion Criteria: 1. Concomitant posterior cruciate ligament or lateral collateral ligament injury in the same knee; 2. Injury to the contralateral side; 3. Medical problems that are contradictory to WBV; 4. Prior experience of WBV to avoid any training or memory effect; 5. Women with pregnancy.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
whole body vibration
The whole body vibration is used when vibrations (mechanical oscillations) of a certain frequency are transferred to the human body. Humans are exposed to vibration through a contact surface that is in a mechanical vibrating state. It has been considered as an alternative and safe method for neuromuscular training and may be incorporated into current neuromuscular rehabilitation programs so as to enhance muscle recovery
Conventional exercise training
A set of conventional exercises designed for ACL rehabilitation

Locations

Country Name City State
Hong Kong The chinese University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary knee flexion angle Peak value of knee flexion will be assessed by the skin marker-based motion analysis system (Vicon MX, Oxford, UK) during single leg squat and single leg hop landing. immediately after intervention, three month after intervention
Primary knee valgus angle Peak value of knee valgus will be assessed by the skin marker-based motion analysis system (Vicon MX, Oxford, UK) during single leg squat and single leg hop landing. immediately after intervention, three month after intervention
Primary knee internal rotation angle Peak value of knee internal rotation will be assessed by the skin marker-based motion analysis system (Vicon MX, Oxford, UK) during single leg squat and single leg hop landing. immediately after intervention, three month after intervention
Primary Vertical ground reaction force Peak vertical ground reaction force will be evaluated by a synchronized force plate during single leg hop landing. immediately after intervention, three month after intervention
Primary Knee valgus torque Peak knee valgus torque will be evaluated by a synchronized force plate during single leg hop landing. immediately after intervention, three month after intervention
Primary Knee extension torque Peak knee extension torque will be evaluated by a synchronized force plate during single leg hop landing. immediately after intervention, three month after intervention
Secondary muscle strength Isometric muscle strength of quadriceps and hamstring will be tested using an hand-held dynamometer. The isokinetic muscle strength of quadriceps and hamstring will be tested at 60°/s and 180°/s by the isokinetic dynamometer immediately after intervention, three month after intervention
Secondary muscle elasticity Shear elastic modulus of vastus medialis, vastus lateralis, semimembranosus and biceps femoris will be assessed by shear wave elastography ultrasound. immediately after intervention, three month after intervention
Secondary muscle activation Muscle activity level of vastus lateralis, vastus medialis, biceps femoris and semitendinosus will be assessed by electromyography immediately after intervention, three month after intervention
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