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Effect of Dual Tasks on Gait Symmetry After Anterior Cruciate Ligament Reconstruction

Primary Purpose

Anterior Cruciate Ligament Injury

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
command
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anterior Cruciate Ligament Injury focused on measuring anterior cruciate ligament, knee, biomechanics, walking, cognition

Eligibility Criteria

18 Years - 40 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 18-40 years old
  • received unilateral ACL reconstruction

Exclusion Criteria:

  • 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

Sites / Locations

  • Peking University Third Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ACL group

Arm Description

Outcomes

Primary Outcome Measures

knee joint angles
Three-dimensional gait analysis system were used during walking.
the moment of knee flexion in the gait cycle
Three-dimensional gait analysis system were used during walking.
the moment of knee extension in the gait cycle
Three-dimensional gait analysis system were used during walking.

Secondary Outcome Measures

quadriceps strength
Isokinetic muscle strength testing instrument were used to evaluate musle strength.
walking speed
Three-dimensional gait analysis system were used during walking.
The International Knee Documentation Committee (IKDC) score
The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100.

Full Information

First Posted
June 29, 2020
Last Updated
July 6, 2020
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04461145
Brief Title
Effect of Dual Tasks on Gait Symmetry After Anterior Cruciate Ligament Reconstruction
Official Title
Effect of Dual Tasks on Gait Symmetry After Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 8, 2016 (Actual)
Primary Completion Date
October 20, 2017 (Actual)
Study Completion Date
October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Background: Anterior cruciate ligament (ACL) reconstruction is a commonly surgical procedure to restore knee functions after an ACL injury. Lower extremity movement asymmetries were found to be predictive of ACL re-injury and knee OA after ACL reconstruction. Although these studies indicated that psychological impairments may contribute to patients' movement asymmetries after ACL reconstruction surgery, the effect of psychological impairment on lower extremity movement asymmetries has not been confirmed yet. Methods: Each participant was asked to wear a pair of black spandex shorts. Passive reflective markers were placed bilaterally at the anterior superior iliac spine, posterior superior iliac spine, lateral thigh, lateral femoral condyle, medial femoral condyle, anterior superior shank, anterior inferior shank, lateral malleoli, medial malleoli, heel, and first and fifth metatarsophalangeal. The participant was instructed to walk with barefoot in two conditions: (1) without cognitive task (single-task condition), and (2) with concurrent cognitive task (dual-task condition). In single-task condition, the participant walked along a 10-m walkway at self-selected walking speed. In dual-task condition, the participant walked along the walkway while backward counting numbers with an increment of seven starting from a randomly given number between 125 and 250. In dual-task condition, participants immediately initiated the walking task at their preferred speed once they heard the number read by the investigator and kept counting out loudly as required without repeating the given number. Participants were asked to count as fast as possible while walking task. A 5 min rest was requested between single-task and dual-task test. The order of conditions was randomized for the participant. Quadriceps strength was evaluated for the participant after walking test. Three-dimensional (3-D) trajectories of the reflective markers were collected using an 8-camera motion capture system (VICON, Oxford, UK) at a sample rate of 100 Hz. Ground-reaction force signals were collected using two embedded force plates (AMTI, Watertown, Massachusetts) at a sample rate of 1000 Hz. Each participant was asked to have three successful trials for each condition. A successful trial was defined as a trial in which the participant performed the task as required, and all kinematic and kinetic data were collected. Quadriceps isometric strength was quantified with an isokinetic dynamometer (CON-TREX MJ; Germany) during a maximum voluntary isometric contraction (MVIC). The participant was seated with a hip flexed at 90° and knee flexed at 60°. The lateral femoral condyle was aligned with the dynamometer axis, and the dynamometer resistance pad was secured to the anterior aspect of the distal shank. After correcting for leg weight, the participant was asked to perform submaximal practice to familiarize themselves with the testing apparatus. After familiarization of testing apparatus, the participant was asked to have three recorded maximum-effort trials (5 seconds in duration, 60 seconds' rest between trials) for each leg with uninjured leg tested first.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injury
Keywords
anterior cruciate ligament, knee, biomechanics, walking, cognition

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACL group
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
command
Intervention Description
The participant was asked to walk along the walkway while backward counting numbers with increment of seven starting from a randomly given number.
Primary Outcome Measure Information:
Title
knee joint angles
Description
Three-dimensional gait analysis system were used during walking.
Time Frame
at 6 months after the surgery.
Title
the moment of knee flexion in the gait cycle
Description
Three-dimensional gait analysis system were used during walking.
Time Frame
at 6 months after the surgery.
Title
the moment of knee extension in the gait cycle
Description
Three-dimensional gait analysis system were used during walking.
Time Frame
at 6 months after the surgery.
Secondary Outcome Measure Information:
Title
quadriceps strength
Description
Isokinetic muscle strength testing instrument were used to evaluate musle strength.
Time Frame
at 6 months after the surgery.
Title
walking speed
Description
Three-dimensional gait analysis system were used during walking.
Time Frame
at 6 months after the surgery.
Title
The International Knee Documentation Committee (IKDC) score
Description
The International Knee Documentation Committee (IKDC) score was used to evaluate the knee health.The patients completed score by themselves. The lowest score is 0 and the highest score is 100.
Time Frame
at 6 months after the surgery.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-40 years old received unilateral ACL reconstruction Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongshi Huang, Doctor
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Dual Tasks on Gait Symmetry After Anterior Cruciate Ligament Reconstruction

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