Anterior Cruciate Ligament InjuryNCT04461145
Effect of Dual Tasks on Gait Symmetry After Anterior Cruciate Ligament Reconstruction
A study testing command in people with Anterior Cruciate Ligament Injury, run by Peking University Third Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- command
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2016to 31 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 18-40 years old
- received unilateral ACL reconstruction
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- command
- Keywords
- anterior cruciate ligament, knee, biomechanics, walking, cognition
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
commandBehavioural
The participant was asked to walk along the walkway while backward counting numbers with increment of seven starting from a randomly given number.
| Study group | Role | What they receive |
|---|---|---|
| ACL group | Other | Not described Receives: Behavioral: command |
What is being measured
The primary outcome is the main question the study is designed to answer.
knee joint angles
Three-dimensional gait analysis system were used during walking.
Measured: at 6 months after the surgery.
the moment of knee flexion in the gait cycle
Three-dimensional gait analysis system were used during walking.
Measured: at 6 months after the surgery.
the moment of knee extension in the gait cycle
Three-dimensional gait analysis system were used during walking.
Measured: at 6 months after the surgery.
Secondary outcomes (3)
quadriceps strength
Isokinetic muscle strength testing instrument were used to evaluate musle strength.
Measured: at 6 months after the surgery.
walking speed
Three-dimensional gait analysis system were used during walking.
Measured: at 6 months after the surgery.
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.
Measured: at 6 months after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start8 Nov 2016
- Primary completion20 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongshi Huang, Doctor, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461145
- Sponsor's protocol ID
- OR002
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dual Tasks on Gait Symmetry After Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT04461145
- Acronym / sponsor ID
- OR002
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- anterior cruciate ligament, knee, biomechanics, walking, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- 20 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACL group | Other | Behavioral: command |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18-40 years old
- received unilateral ACL reconstruction
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| commandThe participant was asked to walk along the walkway while backward counting numbers with increment of seven starting from a randomly given number. | Behavioural | ACL group |
Primary outcome
knee joint angles
Time frame: at 6 months after the surgery.
Three-dimensional gait analysis system were used during walking.
the moment of knee flexion in the gait cycle
Time frame: at 6 months after the surgery.
Three-dimensional gait analysis system were used during walking.
the moment of knee extension in the gait cycle
Time frame: at 6 months after the surgery.
Three-dimensional gait analysis system were used during walking.
3 secondary outcomes
quadriceps strength
Time frame: at 6 months after the surgery.
walking speed
Time frame: at 6 months after the surgery.
The International Knee Documentation Committee (IKDC) score
Time frame: at 6 months after the surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongshi Huang, Doctor study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing command in people with Anterior Cruciate Ligament Injury, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knee joint angles (time frame: at 6 months after the surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.