The Effect of Early WBVT on Neuromuscular Control After ACLR

Rupture of Anterior Cruciate Ligament Clinical Trial

— WBVT  

Official title:

The Effect of Early Whole-Body Vibration Therapy on Neuromuscular Control After Anterior Cruciate Ligament Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01300182
• Other study ID #: wbvtrct
• Status: Completed
• Phase: N/A
• First received: February 18, 2011
• Last updated: February 12, 2013
• Start date: November 2010
• Est. completion date: February 2012

Study information

• Verified date: February 2013
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rupture of Anterior Cruciate Ligament

Intervention

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.
• Control
Conventional post-operative physical therapy exercises and rehabilitation.

Locations

Country	Name	City	State
Hong Kong	Physiotherapy Department, Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Joint position sense	Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.	1-month post-operation, 3-months post-operation, 6-months post-operation	No
Primary	Muscle isokinetic strength	Using Cybex NORM dynamometer for measurement.	Pre-operation, 3-months post-operation, 6-months post-operation	No
Primary	Postural control	Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement	1-month post-operation, 3-months post-operation, 6-months post-operation	No
Primary	Functional Outcome	Functional Outcomes; single leg hop test; triple leg hop test; caricoca test; Shuttle run test	Pre-operation and 6-months post-operation	No
Primary	Knee joint stability		Pre-operation, 3-months post-operation, 6-months post-operation	No
Primary	Knee range of motion		6-months post operation	No