- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05254054
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
Intervention / Treatment
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
- Name: Xin He, PhD
- Phone Number: 68102694
- Email: xinhe@cuhk.edu.hk
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:
- 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.
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019.432
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.
Clinical Trials on ACL Injury
-
Sichuan Province Orthopetic HospitalCompleted
-
Copenhagen University Hospital, HvidovreUniversity of Copenhagen; University College Copenhagen; Team DenmarkActive, not recruitingACL Injury PreventionDenmark
-
University Hospital, Basel, SwitzerlandCompletedAnterior Cruciate Ligament (ACL) InjurySwitzerland
-
University Hospital, CaenINSERM UMR U1075 Comète GIP Cyceron, unicaen, Caen NormandieActive, not recruitingACL Reconstruction | ACL Injuries | ACL SurgeryFrance
-
Università degli studi di Roma Foro ItalicoNot yet recruitingAnterior Cruciate Ligament Injuries | Anterior Cruciate Ligament Rupture | ACL Injury | ACL Tear | ACL Sprain
-
University of ManitobaUnknown
-
Vita CareJohnson & JohnsonRecruitingKnee Injuries | ACL Injury | Sports Injury | ACL TearBrazil
-
King Saud UniversityCompleted
-
University of LahoreCompleted
-
Stefano ZaffagniniRecruitingTenodesis | ACL Reconstruction | ACL InjuriesItaly
Clinical Trials on whole body vibration
-
The Hong Kong Polytechnic UniversityCompleted
-
Pamukkale UniversityNot yet recruitingPatellofemoral Pain, PFPTurkey (Türkiye)
-
Gazi UniversityGulhane Training and Research HospitalCompletedArthropathy of Knee | Whole-body Vibration | Swelling/ EdemaTurkey
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityCompletedHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | Chemotherapy-Induced Peripheral NeuropathyUnited States
-
University of the Balearic IslandsUnknown
-
The Hong Kong Polytechnic UniversityUnknown
-
Cairo UniversityNot yet recruitingQuality of Life | Balance | Chemotherapy Induced Peripheral Neuropathy (CIPN) | Fall Risk, Fall Prevention | Whole Body Vibration
-
Uludag UniversityNot yet recruiting
-
Cairo UniversityRecruitingOverweight , ObesitySaudi Arabia