ACL InjuryNCT05254054
The Effect of Whole Body Vibration After ACLR
A study testing whole body vibration and Conventional exercise training in people with ACL Injury, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- ACL Injury
- What is being tested?
- whole body vibration and Conventional exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2021to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
The chinese University of Hong Kong
Hong Kong
Michael Tim-Yun Ong, Master
About this study
Official title: 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
Read the 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.
- Conditions
- ACL Injury
- Being tested
- whole body vibration, Conventional exercise training
- Keywords
- ACL, dynamic knee stability, whole body vibration
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibrationOther
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 trainingOther
A set of conventional exercises designed for ACL rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Vibration group | Experimental | Participants in Vibration group will receive an 8-week whole body vibration training in addition to conventional exercise training. Receives: Other: whole body vibration; Other: Conventional exercise training |
| Control group | Active comparator | Participants in Vibration group will only receive conventional exercise training. Receives: Other: Conventional exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately after intervention, three month after intervention
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.
Measured: immediately after intervention, three month after intervention
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.
Measured: immediately after intervention, three month after intervention
Vertical ground reaction force
Peak vertical ground reaction force will be evaluated by a synchronized force plate during single leg hop landing.
Measured: immediately after intervention, three month after intervention
Knee valgus torque
Peak knee valgus torque will be evaluated by a synchronized force plate during single leg hop landing.
Measured: immediately after intervention, three month after intervention
Knee extension torque
Peak knee extension torque will be evaluated by a synchronized force plate during single leg hop landing.
Measured: immediately after intervention, three month after intervention
Secondary outcomes (3)
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
Measured: immediately after intervention, three month after intervention
muscle elasticity
Shear elastic modulus of vastus medialis, vastus lateralis, semimembranosus and biceps femoris will be assessed by shear wave elastography ultrasound.
Measured: immediately after intervention, three month after intervention
muscle activation
Muscle activity level of vastus lateralis, vastus medialis, biceps femoris and semitendinosus will be assessed by electromyography
Measured: immediately after intervention, three month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start1 Jan 2021
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL InjuryStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin He, Chinese University of Hong Kong
- Investigators
- Xin He, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254054
- Sponsor's protocol ID
- 2019.432
- Status last verified
- Aug 2023
- First submitted
- 27 Jan 2022
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whole Body Vibration on Dynamic Knee Stability in Patients After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT05254054
- Acronym / sponsor ID
- 2019.432
- Conditions
- ACL Injury
- Keywords
- ACL, dynamic knee stability, whole body vibration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Vibration group | Experimental | Other: whole body vibration, Other: Conventional exercise trainingParticipants in Vibration group will receive an 8-week whole body vibration training in addition to conventional exercise training. |
| Control group | Active comparator | Other: Conventional exercise trainingParticipants in Vibration group will only receive conventional exercise training. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole body vibrationThe 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 | Other | Vibration group |
| Conventional exercise trainingA set of conventional exercises designed for ACL rehabilitation | Other | Control group, Vibration group |
Primary outcome
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.
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.
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.
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.
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.
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.
3 secondary outcomes
muscle strength
Time frame: immediately after intervention, three month after intervention
muscle elasticity
Time frame: immediately after intervention, three month after intervention
muscle activation
Time frame: immediately after intervention, three month after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for ACL Injury
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Graded Exposure and Mindfulness Meditation for Patients Post-ACL Reconstruction
Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin He, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body vibration and Conventional exercise training in people with ACL Injury, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin He, PhD (68102694, xinhe@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee flexion angle (time frame: immediately after intervention, three month after intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.