- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01300182
The Effect of Early WBVT on Neuromuscular Control After ACLR (WBVT)
The Effect of Early Whole-Body Vibration Therapy on Neuromuscular Control After Anterior Cruciate Ligament Reconstruction
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Shatin, Hong Kong, 852
- Physiotherapy Department, Prince of Wales Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Whole body vibration therapy
Whole body vibration therapy on top of conventional physiotherapy treatment.
|
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 Names:
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Active Comparator: Control
Conventional post-operative physical therapy rehabilitation exercises.
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Conventional post-operative physical therapy exercises and rehabilitation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Joint position sense
Time Frame: 1-month post-operation, 3-months post-operation, 6-months post-operation
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Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.
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1-month post-operation, 3-months post-operation, 6-months post-operation
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Muscle isokinetic strength
Time Frame: Pre-operation, 3-months post-operation, 6-months post-operation
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Using Cybex NORM dynamometer for measurement.
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Pre-operation, 3-months post-operation, 6-months post-operation
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Postural control
Time Frame: 1-month post-operation, 3-months post-operation, 6-months post-operation
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Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement
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1-month post-operation, 3-months post-operation, 6-months post-operation
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Functional Outcome
Time Frame: Pre-operation and 6-months post-operation
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Functional Outcomes
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Pre-operation and 6-months post-operation
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Knee joint stability
Time Frame: Pre-operation, 3-months post-operation, 6-months post-operation
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Pre-operation, 3-months post-operation, 6-months post-operation
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Knee range of motion
Time Frame: 6-months post operation
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6-months post operation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Chak Lun Allan Fu, Physiotherapy Department, Prince of Wales Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- wbvtrct
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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