NCT04461145

Brief Summary

Individuals who received anterior cruciate ligament (ACL) reconstruction demonstrated lower extremity movement asymmetries. The purpose of this study was to determine if psychological impairment was a contributor to lower extremity movement asymmetries in walking for individuals who received ACL reconstruction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2017

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 8, 2020

Completed
Last Updated

July 8, 2020

Status Verified

June 1, 2020

Enrollment Period

12 months

First QC Date

June 29, 2020

Last Update Submit

July 6, 2020

Conditions

Anterior Cruciate Ligament Injury

Keywords

anterior cruciate ligamentkneebiomechanicswalkingcognition

Outcome Measures

Primary Outcomes (3)

  • knee joint angles

    Three-dimensional gait analysis system were used during walking.

    at 6 months after the surgery.

  • the moment of knee flexion in the gait cycle

    Three-dimensional gait analysis system were used during walking.

    at 6 months after the surgery.

  • the moment of knee extension in the gait cycle

    Three-dimensional gait analysis system were used during walking.

    at 6 months after the surgery.

Secondary Outcomes (3)

  • quadriceps strength

    at 6 months after the surgery.

  • walking speed

    at 6 months after the surgery.

  • The International Knee Documentation Committee (IKDC) score

    at 6 months after the surgery.

Study Arms (1)

ACL group

OTHER
Behavioral: command

Interventions

commandBEHAVIORAL

The participant was asked to walk along the walkway while backward counting numbers with increment of seven starting from a randomly given number.

ACL group

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • received unilateral ACL reconstruction

You may not qualify if:

  • combined with other ligament injuries
  • moderate or severe articular cartilage damage to the patellofemoral and tibiofemoral joint
  • combined with meniscus injuries that needed to be repaired with a resection or suture
  • other current orthopaedic injuries or disorders that were still affecting lower extremity movements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Hongshi Huang, Doctor

    Peking University Third Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 8, 2020

Study Start

November 8, 2016

Primary Completion

October 20, 2017

Study Completion

October 31, 2017

Last Updated

July 8, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)