The Effect of Early WBVT on Neuromuscular Control After ACLR

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fu Chak Lun Allan, Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT01300182
First received: February 18, 2011
Last updated: February 12, 2013
Last verified: February 2013

February 18, 2011
February 12, 2013
November 2010
February 2012   (final data collection date for primary outcome measure)
  • Joint position sense [ Time Frame: 1-month post-operation, 3-months post-operation, 6-months post-operation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Using Cybex NORM dynamometer for measurement.
  • Postural control [ Time Frame: 1-month post-operation, 3-months post-operation, 6-months post-operation ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Knee range of motion [ Time Frame: 6-months post operation ] [ Designated as safety issue: No ]
  • Joint position sense 3 [ Time Frame: Joint position sense at 3 months post-operation ] [ Designated as safety issue: Yes ]
    Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.
  • Muscle Strength 2 [ Time Frame: Muscle strength at 3-months post-operation ] [ Designated as safety issue: Yes ]
    Using Cybex NORM dynamometer for measurement.
  • Postural balance 2 [ Time Frame: Postural balance at 1 month post-operation ] [ Designated as safety issue: Yes ]
    Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement
  • Functional Outcome 1 [ Time Frame: Functional Outcome at pre-operation ] [ Designated as safety issue: Yes ]

    Functional Outcomes

    • single leg hop test
    • triple leg hop test
    • caricoca test
    • Shuttle run test
    • vertical jump test
  • Joint position sense 1 [ Time Frame: Joint position sense at pre-operation ] [ Designated as safety issue: Yes ]
    Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.
  • Joint position sense 2 [ Time Frame: Joint position sense at 1 month post-operation ] [ Designated as safety issue: Yes ]
    Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.
  • Joint Position Sense 4 [ Time Frame: Joint Position Sense at 6 months post-operation ] [ Designated as safety issue: Yes ]
    Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.
  • Joint position sense 5 [ Time Frame: Joint position sense at 9 month post-operation ] [ Designated as safety issue: Yes ]
    Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.
  • Muscle Strength 1 [ Time Frame: Muscle strength at pre-operation ] [ Designated as safety issue: Yes ]
    Using Cybex NORM dynamometer for measurement.
  • Muscle Strength 3 [ Time Frame: Muscle strength at 6-months post-operation ] [ Designated as safety issue: Yes ]
    Using Cybex NORM dynamometer for measurement.
  • Muscle Strength 4 [ Time Frame: Muscle strength at 9-months post-operation ] [ Designated as safety issue: Yes ]
    Using Cybex NORM dynamometer for measurement.
  • Postural balance 1 [ Time Frame: Postural balance at pre-operation ] [ Designated as safety issue: Yes ]
    Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement
  • Postural balance 3 [ Time Frame: Postural balance at 3 month post-operation ] [ Designated as safety issue: Yes ]
    Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement
  • Postural balance 4 [ Time Frame: Postural balance at 6 month post-operation ] [ Designated as safety issue: Yes ]
    Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement
  • Postural balance 5 [ Time Frame: Postural balance at 9 month post-operation ] [ Designated as safety issue: Yes ]
    Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement
  • Functional Outcome 2 [ Time Frame: Functional Outcome at 6 month post-operation ] [ Designated as safety issue: Yes ]

    Functional Outcomes

    • single leg hop test
    • triple leg hop test
    • caricoca test
    • Shuttle run test
    • vertical jump test
  • Functional Outcome 3 [ Time Frame: Functional Outcome at 9 month post-operation ] [ Designated as safety issue: Yes ]

    Functional Outcomes

    • single leg hop test
    • triple leg hop test
    • caricoca test
    • Shuttle run test
    • vertical jump test
Complete list of historical versions of study NCT01300182 on ClinicalTrials.gov Archive Site
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The Effect of Early WBVT on Neuromuscular Control After ACLR
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Rupture of Anterior Cruciate Ligament
  • Other: Whole body vibration therapy
    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 Name: Fitvibe Excel Pro - model number: 332015 (N.V. GymnaYniphy, Bilzen, Belgium)
  • Other: Control
    Conventional post-operative physical therapy exercises and rehabilitation.
  • Experimental: Whole body vibration therapy
    Whole body vibration therapy on top of conventional physiotherapy treatment.
    Intervention: Other: Whole body vibration therapy
  • Active Comparator: Control
    Conventional post-operative physical therapy rehabilitation exercises.
    Intervention: Other: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT01300182
wbvtrct
Yes
Fu Chak Lun Allan, Hospital Authority, Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Chak Lun Allan Fu Physiotherapy Department, Prince of Wales Hospital
Chinese University of Hong Kong
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP