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The Effect of Early WBVT on Neuromuscular Control After ACLR (WBVT)

Primary Purpose

Rupture of Anterior Cruciate Ligament

Status

Completed

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

Whole body vibration therapy

Control

About this trial

This is an interventional treatment trial for Rupture of Anterior Cruciate Ligament focused on measuring ACLR

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Physiotherapy Department, Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Whole body vibration therapy

Control

Arm Description

Whole body vibration therapy on top of conventional physiotherapy treatment.

Conventional post-operative physical therapy rehabilitation exercises.

Outcomes

Primary Outcome Measures

Joint position sense

Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.

Muscle isokinetic strength

Using Cybex NORM dynamometer for measurement.

Postural control

Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement

Functional Outcome

Functional Outcomes single leg hop test triple leg hop test caricoca test Shuttle run test

Knee joint stability

Knee range of motion

Secondary Outcome Measures

Full Information

NCT ID

NCT01300182

First Posted

February 18, 2011

Last Updated

February 12, 2013

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT01300182

Brief Title

The Effect of Early WBVT on Neuromuscular Control After ACLR

Acronym

WBVT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rupture of Anterior Cruciate Ligament

Keywords

ACLR

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Whole body vibration therapy

Arm Type

Experimental

Arm Description

Whole body vibration therapy on top of conventional physiotherapy treatment.

Arm Title

Control

Arm Type

Active Comparator

Arm Description

Conventional post-operative physical therapy rehabilitation exercises.

Intervention Type

Other

Intervention Name(s)

Whole body vibration therapy

Other Intervention Name(s)

Fitvibe Excel Pro - model number: 332015 (N.V. GymnaYniphy, Bilzen, Belgium)

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Control

Intervention Description

Conventional post-operative physical therapy exercises and rehabilitation.

Primary Outcome Measure Information:

Title

Joint position sense

Description

Using Biodex Dynamometer (Biodex Medical Systems, Shirley, NY, USA) for measurement.

Time Frame

1-month post-operation, 3-months post-operation, 6-months post-operation

Title

Muscle isokinetic strength

Description

Using Cybex NORM dynamometer for measurement.

Time Frame

Pre-operation, 3-months post-operation, 6-months post-operation

Title

Postural control

Description

Using Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA with software version 3.1) for measurement

Time Frame

1-month post-operation, 3-months post-operation, 6-months post-operation

Title

Functional Outcome

Description

Functional Outcomes single leg hop test triple leg hop test caricoca test Shuttle run test

Time Frame

Pre-operation and 6-months post-operation

Title

Knee joint stability

Time Frame

Pre-operation, 3-months post-operation, 6-months post-operation

Title

Knee range of motion

Time Frame

6-months post operation

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chak Lun Allan Fu

Organizational Affiliation

Physiotherapy Department, Prince of Wales Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Physiotherapy Department, Prince of Wales Hospital

City

Shatin

ZIP/Postal Code

852

Country

Hong Kong

12. IPD Sharing Statement

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The Effect of Early WBVT on Neuromuscular Control After ACLR

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