- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04461145
Effect of Dual Tasks on Gait Symmetry After Anterior Cruciate Ligament Reconstruction
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Beijing, China, 100191
- Peking University Third Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: ACL group
|
The participant was asked to walk along the walkway while backward counting numbers with increment of seven starting from a randomly given number.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
knee joint angles
Time Frame: at 6 months after the surgery.
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Three-dimensional gait analysis system were used during walking.
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at 6 months after the surgery.
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the moment of knee flexion in the gait cycle
Time Frame: at 6 months after the surgery.
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Three-dimensional gait analysis system were used during walking.
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at 6 months after the surgery.
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the moment of knee extension in the gait cycle
Time Frame: at 6 months after the surgery.
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Three-dimensional gait analysis system were used during walking.
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at 6 months after the surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quadriceps strength
Time Frame: at 6 months after the surgery.
|
Isokinetic muscle strength testing instrument were used to evaluate musle strength.
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at 6 months after the surgery.
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walking speed
Time Frame: at 6 months after the surgery.
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Three-dimensional gait analysis system were used during walking.
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at 6 months after the surgery.
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The International Knee Documentation Committee (IKDC) score
Time Frame: at 6 months after the surgery.
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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.
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at 6 months after the surgery.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OR002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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