search
Back to results

The Effect of Whole Body Vibration After ACLR

Primary Purpose

ACL Injury

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
whole body vibration
Conventional exercise training
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for ACL Injury focused on measuring ACL, dynamic knee stability, whole body vibration

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The chinese University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vibration group

Control group

Arm Description

Participants in Vibration group will receive an 8-week whole body vibration training in addition to conventional exercise training.

Participants in Vibration group will only receive conventional exercise training.

Outcomes

Primary Outcome Measures

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.
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.
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.
Vertical ground reaction force
Peak vertical ground reaction force will be evaluated by a synchronized force plate during single leg hop landing.
Knee valgus torque
Peak knee valgus torque will be evaluated by a synchronized force plate during single leg hop landing.
Knee extension torque
Peak knee extension torque will be evaluated by a synchronized force plate during single leg hop landing.

Secondary Outcome Measures

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
muscle elasticity
Shear elastic modulus of vastus medialis, vastus lateralis, semimembranosus and biceps femoris will be assessed by shear wave elastography ultrasound.
muscle activation
Muscle activity level of vastus lateralis, vastus medialis, biceps femoris and semitendinosus will be assessed by electromyography

Full Information

First Posted
January 27, 2022
Last Updated
August 29, 2023
Sponsor
Chinese University of Hong Kong
search

1. Study Identification

Unique Protocol Identification Number
NCT05254054
Brief Title
The Effect of Whole Body Vibration After ACLR
Official Title
The Effect of Whole Body Vibration on Dynamic Knee Stability in Patients After Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury
Keywords
ACL, dynamic knee stability, whole body vibration

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized control trial. Participants will be randomly allocated into either intervention group(vibration training+ conventional rehabilitation program) or control group(conventional rehabilitation program).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vibration group
Arm Type
Experimental
Arm Description
Participants in Vibration group will receive an 8-week whole body vibration training in addition to conventional exercise training.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants in Vibration group will only receive conventional exercise training.
Intervention Type
Other
Intervention Name(s)
whole body vibration
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Conventional exercise training
Intervention Description
A set of conventional exercises designed for ACL rehabilitation
Primary Outcome Measure Information:
Title
knee flexion angle
Description
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.
Time Frame
immediately after intervention, three month after intervention
Title
knee valgus angle
Description
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.
Time Frame
immediately after intervention, three month after intervention
Title
knee internal rotation angle
Description
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.
Time Frame
immediately after intervention, three month after intervention
Title
Vertical ground reaction force
Description
Peak vertical ground reaction force will be evaluated by a synchronized force plate during single leg hop landing.
Time Frame
immediately after intervention, three month after intervention
Title
Knee valgus torque
Description
Peak knee valgus torque will be evaluated by a synchronized force plate during single leg hop landing.
Time Frame
immediately after intervention, three month after intervention
Title
Knee extension torque
Description
Peak knee extension torque will be evaluated by a synchronized force plate during single leg hop landing.
Time Frame
immediately after intervention, three month after intervention
Secondary Outcome Measure Information:
Title
muscle strength
Description
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
Time Frame
immediately after intervention, three month after intervention
Title
muscle elasticity
Description
Shear elastic modulus of vastus medialis, vastus lateralis, semimembranosus and biceps femoris will be assessed by shear wave elastography ultrasound.
Time Frame
immediately after intervention, three month after intervention
Title
muscle activation
Description
Muscle activity level of vastus lateralis, vastus medialis, biceps femoris and semitendinosus will be assessed by electromyography
Time Frame
immediately after intervention, three month after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-50; Physically active before injury with Tegner score more than 6 (recreational/professional sport level); Scheduled for ACLR because of sport injury; Be able to walk with a pair of elbow crutches independently at 1 month after ACLR. Exclusion Criteria: Concomitant posterior cruciate ligament or lateral collateral ligament injury in the same knee; Injury to the contralateral side; Medical problems that are contradictory to WBV; Prior experience of WBV to avoid any training or memory effect; Women with pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin He, PhD
Phone
68102694
Email
xinhe@cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin He, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The chinese University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Tim-Yun Ong, Master

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Whole Body Vibration After ACLR

We'll reach out to this number within 24 hrs