NCT01300182

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

1.3 years

First QC Date

February 18, 2011

Last Update Submit

February 12, 2013

Conditions

Keywords

ACLR

Outcome Measures

Primary Outcomes (6)

  • 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

  • Muscle isokinetic strength

    Using Cybex NORM dynamometer for measurement.

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

  • 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

  • Functional Outcome

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

    Pre-operation and 6-months post-operation

  • Knee joint stability

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

  • Knee range of motion

    6-months post operation

Study Arms (2)

Whole body vibration therapy

EXPERIMENTAL

Whole body vibration therapy on top of conventional physiotherapy treatment.

Other: Whole body vibration therapy

Control

ACTIVE COMPARATOR

Conventional post-operative physical therapy rehabilitation exercises.

Other: Control

Interventions

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.

Also known as: Fitvibe Excel Pro - model number: 332015 (N.V. GymnaYniphy, Bilzen, Belgium)
Whole body vibration therapy
ControlOTHER

Conventional post-operative physical therapy exercises and rehabilitation.

Control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiotherapy Department, Prince of Wales Hospital

Shatin, Hong Kong, 852, Hong Kong

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Chak Lun Allan Fu

    Physiotherapy Department, Prince of Wales Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr Fu Chak Lun Allan

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 21, 2011

Study Start

November 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 13, 2013

Record last verified: 2013-02

Locations