NCT05254054

Brief Summary

This is a randomised clinical trial to detect the effect of an 8-week whole body vibration training on muscle function and dynamic knee function during single leg squat and single leg hop in patients after anterior cruciate ligament reconstruction

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

4 years

First QC Date

January 27, 2022

Last Update Submit

August 29, 2023

Conditions

Keywords

ACLdynamic knee stabilitywhole body vibration

Outcome Measures

Primary Outcomes (6)

  • knee flexion angle

    Peak value of knee flexion will be assessed by the skin marker-based motion analysis system (Vicon MX, Oxford, UK) during single leg squat and single leg hop landing.

    immediately after intervention, three month after intervention

  • knee valgus angle

    Peak value of knee valgus will be assessed by the skin marker-based motion analysis system (Vicon MX, Oxford, UK) during single leg squat and single leg hop landing.

    immediately after intervention, three month after intervention

  • knee internal rotation angle

    Peak value of knee internal rotation will be assessed by the skin marker-based motion analysis system (Vicon MX, Oxford, UK) during single leg squat and single leg hop landing.

    immediately after intervention, three month after intervention

  • Vertical ground reaction force

    Peak vertical ground reaction force will be evaluated by a synchronized force plate during single leg hop landing.

    immediately after intervention, three month after intervention

  • Knee valgus torque

    Peak knee valgus torque will be evaluated by a synchronized force plate during single leg hop landing.

    immediately after intervention, three month after intervention

  • Knee extension torque

    Peak knee extension torque will be evaluated by a synchronized force plate during single leg hop landing.

    immediately after intervention, three month after intervention

Secondary Outcomes (3)

  • muscle strength

    immediately after intervention, three month after intervention

  • muscle elasticity

    immediately after intervention, three month after intervention

  • muscle activation

    immediately after intervention, three month after intervention

Study Arms (2)

Vibration group

EXPERIMENTAL

Participants in Vibration group will receive an 8-week whole body vibration training in addition to conventional exercise training.

Other: whole body vibrationOther: Conventional exercise training

Control group

ACTIVE COMPARATOR

Participants in Vibration group will only receive conventional exercise training.

Other: Conventional exercise training

Interventions

The whole body vibration is used when vibrations (mechanical oscillations) of a certain frequency are transferred to the human body. Humans are exposed to vibration through a contact surface that is in a mechanical vibrating state. It has been considered as an alternative and safe method for neuromuscular training and may be incorporated into current neuromuscular rehabilitation programs so as to enhance muscle recovery

Vibration group

A set of conventional exercises designed for ACL rehabilitation

Control groupVibration group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18-50;
  • Physically active before injury with Tegner score more than 6 (recreational/professional sport level);
  • Scheduled for ACLR because of sport injury;
  • Be able to walk with a pair of elbow crutches independently at 1 month after ACLR.

You may not qualify if:

  • Concomitant posterior cruciate ligament or lateral collateral ligament injury in the same knee;
  • Injury to the contralateral side;
  • Medical problems that are contradictory to WBV;
  • Prior experience of WBV to avoid any training or memory effect;
  • Women with pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Xin He, PhD

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin He, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a randomized control trial. Participants will be randomly allocated into either intervention group(vibration training+ conventional rehabilitation program) or control group(conventional rehabilitation program).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 24, 2022

Study Start

January 1, 2021

Primary Completion

January 1, 2025

Study Completion

December 1, 2025

Last Updated

August 30, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations