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
  Purpose

To investigate the effect of early WBVT on neuromuscular control after ACLR.


Condition Intervention
Rupture of Anterior Cruciate Ligament
Other: Whole body vibration therapy
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Early Whole-Body Vibration Therapy on Neuromuscular Control After Anterior Cruciate Ligament Reconstruction

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: November 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Whole body vibration therapy
Whole body vibration therapy on top of conventional physiotherapy treatment.
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)
Active Comparator: Control
Conventional post-operative physical therapy rehabilitation exercises.
Other: Control
Conventional post-operative physical therapy exercises and rehabilitation.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01300182

Locations
Hong Kong
Physiotherapy Department, Prince of Wales Hospital
Shatin, Hong Kong, 852
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Chak Lun Allan Fu Physiotherapy Department, Prince of Wales Hospital
  More Information

No publications provided

Responsible Party: Fu Chak Lun Allan, Mr Fu Chak Lun Allan, Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier: NCT01300182     History of Changes
Other Study ID Numbers: wbvtrct
Study First Received: February 18, 2011
Last Updated: February 12, 2013
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
ACLR

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on August 19, 2014