Rupture of Anterior Cruciate LigamentWBVTNCT01300182
The Effect of Early WBVT on Neuromuscular Control After ACLR
A study testing Whole body vibration therapy in people with Rupture of Anterior Cruciate Ligament, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
To investigate the effect of early WBVT on neuromuscular control after ACLR. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rupture of Anterior Cruciate Ligament
- What is being tested?
- Whole body vibration therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteHong Kong
- Study dates
- Nov 2010to Feb 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ACLR with a single-bundle approach
- no complication such as wound infection after the ACLR
- able to walk with a pair of elbow crutches independently at one month post operation
Who cannot join
- concomitant posterior cruciate ligament, lateral collateral ligament, and medial collateral ligament injury in the same knee
- previous operation on either lower limbs
- medical problems such as pregnancy, acute thrombosis, serious cardiovascular disease, pacemaker, acute hernia, discopathy, spondylolysis, severe diabetes, epilepsy, recent infections, severe migraine, tumors or kidney stones etc
- neurological conditions such as Guillain-Barre ́ syndrome, myasthenia gravis, and postpolio syndrome
- prior experience of WBVT
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Physiotherapy Department, Prince of Wales Hospital
Shatin, Hong Kong, 852
About this study
Official title: The Effect of Early Whole-Body Vibration Therapy on Neuromuscular Control After Anterior Cruciate Ligament Reconstruction
To investigate the effect of early WBVT on neuromuscular control after ACLR.
Read the detailed description
The knee joint position sense, postural control, muscular strength and functional ability after anterior cruciate ligament construction (ACLR) are distorted, and even after a period of rehabilitation.
Previous studies had demonstrated that there was improvement in knee joint, postural balance, muscle strength and functional outcome in elderly, stroke and spastic patients already. It has also been concluded that the balance in elderly, postmenopausal women, Parkinson's disease, multiple sclerosis, stroke and spastic patients were all significantly improved. Some studies showed that the proprioception in osteoarthritis patients significantly improve. Knee strength is also one of the aspect being improved.
However, no studies focus on the early effect of WBVT on knee joint proprioception, postural control, muscle strength, knee joint stability and functional ability in ACLR cases. This study is to answer this research gap.
- Conditions
- Rupture of Anterior Cruciate Ligament
- Being tested
- Whole body vibration therapy, Control
- Keywords
- ACLR
- 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 vibration therapyOther
Also called Fitvibe Excel Pro - model number: 332015 (N.V. GymnaYniphy, Bilzen, Belgium)
The WBVT will be carried out in a vibration plates operated in vertical direction. The frequency of that vibration can be adjusted step of 5Hz with vibration frequency ranges from 20Hz to 60Hz. The amplitude can be set as 4mm.
ControlOther
Conventional post-operative physical therapy exercises and rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Whole body vibration therapy | Experimental | Whole body vibration therapy on top of conventional physiotherapy treatment. Receives: Other: Whole body vibration therapy |
| Control | Active comparator | Conventional post-operative physical therapy rehabilitation exercises. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Joint position sense
Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.
Measured: 1-month post-operation, 3-months post-operation, 6-months post-operation
Muscle isokinetic strength
Using Cybex NORM dynamometer for measurement.
Measured: Pre-operation, 3-months post-operation, 6-months post-operation
Postural control
Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement
Measured: 1-month post-operation, 3-months post-operation, 6-months post-operation
Functional Outcome
Functional Outcomes
- single leg hop test
- triple leg hop test
- caricoca test
- Shuttle run test
Measured: Pre-operation and 6-months post-operation
Knee joint stability
Measured: Pre-operation, 3-months post-operation, 6-months post-operation
Knee range of motion
Measured: 6-months post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rupture of Anterior Cruciate LigamentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fu Chak Lun Allan, Hospital Authority, Hong Kong
- Investigators
- Chak Lun Allan Fu, Principal investigator, Physiotherapy Department, Prince of Wales Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300182
- Sponsor's protocol ID
- wbvtrct
- Acronym
- WBVT
- Status last verified
- Feb 2013
- First submitted
- 18 Feb 2011
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Whole-Body Vibration Therapy on Neuromuscular Control After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT01300182
- Acronym / sponsor ID
- WBVT / wbvtrct
- Conditions
- Rupture of Anterior Cruciate Ligament
- Keywords
- ACLR
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 21 Feb 2011 (estimated)
- 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.
To investigate the effect of early WBVT on neuromuscular control after ACLR.
Detailed description
The knee joint position sense, postural control, muscular strength and functional ability after anterior cruciate ligament construction (ACLR) are distorted, and even after a period of rehabilitation.
Previous studies had demonstrated that there was improvement in knee joint, postural balance, muscle strength and functional outcome in elderly, stroke and spastic patients already. It has also been concluded that the balance in elderly, postmenopausal women, Parkinson's disease, multiple sclerosis, stroke and spastic patients were all significantly improved. Some studies showed that the proprioception in osteoarthritis patients significantly improve. Knee strength is also one of the aspect being improved.
However, no studies focus on the early effect of WBVT on knee joint proprioception, postural control, muscle strength, knee joint stability and functional ability in ACLR cases. This study is to answer this research gap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration therapy | Experimental | Other: Whole body vibration therapyWhole body vibration therapy on top of conventional physiotherapy treatment. |
| Control | Active comparator | Other: ControlConventional post-operative physical therapy rehabilitation exercises. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- ACLR with a single-bundle approach
- no complication such as wound infection after the ACLR
- able to walk with a pair of elbow crutches independently at one month post operation
Key exclusion criteria (5 listed)
- concomitant posterior cruciate ligament, lateral collateral ligament, and medial collateral ligament injury in the same knee
- previous operation on either lower limbs
- medical problems such as pregnancy, acute thrombosis, serious cardiovascular disease, pacemaker, acute hernia, discopathy, spondylolysis, severe diabetes, epilepsy, recent infections, severe migraine, tumors or kidney stones etc
- neurological conditions such as Guillain-Barre ́ syndrome, myasthenia gravis, and postpolio syndrome
- prior experience of WBVT
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 vibration therapyAlso: Fitvibe Excel Pro - model number: 332015 (N.V. GymnaYniphy, Bilzen, Belgium)The WBVT will be carried out in a vibration plates operated in vertical direction. The frequency of that vibration can be adjusted step of 5Hz with vibration frequency ranges from 20Hz to 60Hz. The amplitude can be set as 4mm. | Other | Whole body vibration therapy |
| ControlConventional post-operative physical therapy exercises and rehabilitation. | Other | Control |
Primary outcome
Joint position sense
Time frame: 1-month post-operation, 3-months post-operation, 6-months post-operation
Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.
Muscle isokinetic strength
Time frame: Pre-operation, 3-months post-operation, 6-months post-operation
Using Cybex NORM dynamometer for measurement.
Postural control
Time frame: 1-month post-operation, 3-months post-operation, 6-months post-operation
Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement
Functional Outcome
Time frame: Pre-operation and 6-months post-operation
Functional Outcomes * single leg hop test * triple leg hop test * caricoca test * Shuttle run test
Knee joint stability
Time frame: Pre-operation, 3-months post-operation, 6-months post-operation
Knee range of motion
Time frame: 6-months post operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2013.
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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.
Chak Lun Allan Fu principal investigator
Physiotherapy Department, Prince of Wales Hospital
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 therapy in people with Rupture of Anterior Cruciate Ligament, 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 3 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: finished, as of the sponsor's last update on 13 Feb 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Joint position sense (time frame: 1-month post-operation, 3-months post-operation, 6-months post-operation). 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 13 Feb 2013.