NCT03135600

Brief Summary

The aim of this study is to investigate the influence of running to kinematic parameters of patients with anterior cruciate ligament.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

April 26, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

April 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2017

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 21, 2017

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

21 days

First QC Date

April 26, 2017

Last Update Submit

May 25, 2017

Conditions

ACL InjuryGait

Keywords

KneeACL InjuryKinematics

Outcome Measures

Primary Outcomes (48)

  • Knee flexion/extension angle at initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee internal/external rotation angle at initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee adduction/abduction angle at initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee anterior/posterior translation at initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee medial/lateral translation at initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee proximal/distal translation at initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee flexion/extension angle at opposite toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee adduction/abduction angle at opposite toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee internal/external rotation angle at opposite toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee anterior/posterior translation at opposite toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee distal/proximal translation at opposite toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee medial/lateral translation at opposite toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee flexion/extension angle at heel rise during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee internal/external rotation angle at heel rise during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee adduction/abduction angle at heel rise during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee anterior/posterior translation at heel rise during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee distal/proximal translation at heel rise during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee medial/lateral translation at heel rise during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee flexion/extension angle at opposite initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee adduction/abduction angle at opposite initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee internal/external rotation angle at opposite initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee anterior/posterior translation at opposite initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee distal/proximal translation at opposite initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee medial/lateral translation at opposite initial contact during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee flexion/extension angle at toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee adduction/abduction angle at toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee internal/external rotation angle at toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee anterior/posterior translation at toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee distal/proximal translation at toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee medial/lateral translation at toe off during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee flexion/extension angle at feet adjacent during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee internal/external rotation angle at feet adjacent during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee adduction/abduction angle at feet adjacent during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee anterior/posterior translation at feet adjacent during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee distal/proximal translation at feet adjacent during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee medial/lateral translation at feet adjacent during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee flexion/extension angle at tibial vertical during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee adduction/abduction angle at tibial vertical during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee internal/external rotation angle at tibial vertical during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee anterior/posterior translation at tibial vertical during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee distal/proximal translation at tibial vertical during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Knee medial/lateral translation at tibial vertical during gait.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Range of motion of knee flexion/extension angle.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Range of motion of knee adduction/abduction angle.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Range of motion of knee internal/external rotation angle.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Range of motion of knee anterior/posterior translation.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Range of motion of knee distal/proximal translation.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

  • Range of motion of knee medial/lateral translation.

    The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.

    1 Day

Study Arms (2)

Normal

EXPERIMENTAL

The participants from this group are healthy people.

Procedure: Procedure

ACLD

EXPERIMENTAL

The participants from this group suffer from anterior cruciate ligament injury.

Procedure: Procedure

Interventions

ProcedurePROCEDURE

Once participants are eligible, they will undergo the experimental procedure. Before data collection, they will walk on a treadmill in barefoot for ten minutes to adapt the condition. The a gait analysis system will collect the data while they walk/run on the treadmill in barefoot at 4/6km/h.

ACLDNormal

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \< age \< 30.
  • Body mass index \< 30.
  • For controls, no history of major injury or surgery in lower limbs; no symptoms of lower limbs; physical examination to test the lower limbs to be healthy.
  • For ACLD group, history of knee injury for at least 2 weeks and able to walk and run; confirmed to be unilateral ACL injury by MRI; knee pain in the knee (ACL injury).
  • The habit of moderate exercise (e.g. Jogging) at least once a week for at least 30 minutes.

You may not qualify if:

  • Body mass index \>30.
  • For controls, injury or surgery in hip/knee/ankle.
  • For ACLD group, injury or surgery in hip/ankle; confirmed to be no ACL injury by arthroscopy.
  • Neuropathic disease.
  • Muscular disease.
  • Lack ability to finish the procedure physically or mentally.
  • Easy to fall.
  • Any other conditions that can influence gait parameters of the lower limbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command

Guangzhou, Guangdong, 510010, China

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Methods

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Yu Zhang, PhD

    Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command, 111 Liuhua Road, Guangzhou 510010, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief surgeon, associate professor

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 1, 2017

Study Start

April 26, 2017

Primary Completion

May 17, 2017

Study Completion

May 21, 2017

Last Updated

May 30, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)