The Effect of Whole Body Vibration After ACLR

August 29, 2023 updated by: Xin He, Chinese University of Hong Kong

The Effect of Whole Body Vibration on Dynamic Knee Stability in Patients After Anterior Cruciate Ligament Reconstruction

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

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Hong Kong, Hong Kong
        • Recruiting
        • The Chinese University of Hong Kong
        • Contact:
          • Michael Tim-Yun Ong, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vibration group
Participants in Vibration group will receive an 8-week whole body vibration training in addition to conventional exercise training.
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
A set of conventional exercises designed for ACL rehabilitation
Active Comparator: Control group
Participants in Vibration group will only receive conventional exercise training.
A set of conventional exercises designed for ACL rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
knee flexion angle
Time Frame: immediately after intervention, three month after intervention
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
knee valgus angle
Time Frame: immediately after intervention, three month after intervention
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
knee internal rotation angle
Time Frame: immediately after intervention, three month after intervention
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
Vertical ground reaction force
Time Frame: immediately after intervention, three month after intervention
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
Knee valgus torque
Time Frame: immediately after intervention, three month after intervention
Peak knee valgus torque will be evaluated by a synchronized force plate during single leg hop landing.
immediately after intervention, three month after intervention
Knee extension torque
Time Frame: immediately after intervention, three month after intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
muscle strength
Time Frame: immediately after intervention, three month after intervention
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
muscle elasticity
Time Frame: immediately after intervention, three month after intervention
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
muscle activation
Time Frame: immediately after intervention, three month after intervention
Muscle activity level of vastus lateralis, vastus medialis, biceps femoris and semitendinosus will be assessed by electromyography
immediately after intervention, three month after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Xin He, PhD, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

February 17, 2022

First Posted (Actual)

February 24, 2022

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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