NCT04988828

Brief Summary

Introduction: Approximately 35% patients can not return to sports after anterior cruciate ligament reconstruction(ACLR). Persistent quadriceps weakness is a factor that prevents patients return to sports. Pre-operative quadriceps strength is a predictor for the outcomes after ACLR. Therefore, enhancing pre-operative quadriceps is important. However, current prehabilitation can not well restore quadriceps strength may be due to quadricep inhibition. Whole body vibration was proposed as a promising intervention to increase muscle strength and modulate quadriceps inhibition simultaneously. Therefore, this study aim to investigate if whole body vibration has the efficacy of enhancing pre-operative quadriceps and modulating quadricep inhibition in patients with ACL injuries. Methods: A randomized controlled trial was designed. Patients with primary ACL injuries, age from 18-45 yrs, BMI\<29, physically active who awaiting ACLR will be included. Patients with any previous lower-limb injuries within 1 year, any cardiovascular or metabolic disorders will be excluded. All the subjects in this study have to finish their routine 5 week prehabilitation as well as the interventions. The primary outcomes of this study include quadriceps strength and quadriceps central activation ratio. Secondary outcomes include the score of IKDC and ACL-RSI, as well as the concentrations of myokines in serum.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

March 16, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 4, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

July 3, 2021

Last Update Submit

August 3, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • quadriceps strength

    Subjects' quadriceps peak torque (both legs) measurement will be completed on an isokinetic strength dynamometer (Biodex System 3, Biodex Medical Systems, Shirley, NY, USA). During the test, subjects are positioned with their hip flexed 90°and knee flexed 30°and subjects are asked to try their very best to ensure the MVIC. Meanwhile, the tester will give encouraging word 'harder and harder' during the process of contraction. The MVIC test will repeat 3 times per subject. And sufficient rest is allowed during the interval of each repeat. In order to standardize the data, individual MVIC peak torque will be divided by the body mass of every subject for the further statistic analysis.

    change from baseline to finishing the intervention

  • quadriceps central activation ratio

    he peak torque recorded from the MVIC test will be inputted into a software to deliver a supramaximal electrical stimulus (from DS7R:10-pulses, 100 Hz train) to the quadriceps muscle once the maximal knee extension torque is reached. The electrical stimulus will be delivered through two self-adhesive stimulating electrodes (8 × 13cm) applied over the vastus lateralis muscle proximally and the vastus medialis distally. Quadriceps activation ratio will be calculated using the central activation ratio formula (CAR), which is (MVIC) / (peak torque generated by the stimulus) \*100. A CAR of 100 was used to represent complete quadriceps activation. CAR values that were ≥ 95 were considered to be 'normal' and/or representative of a healthy CAR value. The maximal CAR value that is collected will be used for statistical analysis.

    change from baseline to finishing the intervention

Secondary Outcomes (3)

  • International Knee Documentation Committee Subjective Knee Form (IKDC)

    change from baseline to finishing the intervention

  • Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)

    change from baseline to finishing the intervention

  • International Physical Activity Questionnaire - Short Form (IPAQ)

    Every week during the 5 week interventions

Study Arms (2)

Control

ACTIVE COMPARATOR

deep squat 1min\*6repetitions

Device: Whole body vibration

Whole body vibration group

EXPERIMENTAL

deep squat on a whole body vibration platform with 30Hz and 4mm amplitude 1min\*6repetitions

Device: Whole body vibration

Interventions

vertical vibration platform with the frequency of 30Hz, amplitude of 4mm. The intervention will last for 5 weeks, twice /week.

ControlWhole body vibration group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI\<19
  • ACL injuries
  • no previous lower limb injury within 1 year
  • physically active before the injury

You may not qualify if:

  • pregnant
  • have any cardiovascular
  • nervous or metabolic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince Wales Hospital

Hong Kong, 999077, Hong Kong

RECRUITING

Related Publications (1)

  • Qiu J, Ong MT, Choi CY, Cao M, Ko VM, He X, Fu SC, Fong DTP, Yung PS. Five Weeks of Whole-body Vibration in Prehabilitation for Knee Function Following Anterior Cruciate Ligament Reconstruction: A Single-blinded Randomized Controlled Trial. Sports Med Open. 2025 Aug 22;11(1):98. doi: 10.1186/s40798-025-00901-1.

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Michae Tim-Yun Ong, MSc

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michae Tim-Yun Ong, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PrincipL Investigator

Study Record Dates

First Submitted

July 3, 2021

First Posted

August 4, 2021

Study Start

March 16, 2021

Primary Completion

July 1, 2022

Study Completion

September 1, 2022

Last Updated

August 9, 2021

Record last verified: 2021-08

Locations