Anterior Cruciate Ligament InjuriesNCT04922268
External Focus of Attention Posttraumatic Osteoarthritis
A study testing Internal focus of attention feedback and External focus of attention feedback in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by University of North Carolina, Charlotte at 1 site in United States.
Trial summary
Knee injuries, especially those to the ACL, are common among physically active people. These injuries are frequently treated with surgical reconstruction (ACL reconstruction; ACLR). Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear
- What is being tested?
- Internal focus of attention feedback and External focus of attention feedback
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 31 Aug 2024
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- history of primary, unilateral ACL reconstruction 6-24 months prior to enrollment
- cleared to return to full activity by treating orthopedic surgeon
Who cannot join
- Body mass index >35 kg/m2
- History of musculoskeletal injury sustained 3 months prior to enrollment
- Current participation in formal post-operative rehabilitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Focus of Attention Feedback to Mitigate Posttraumatic Osteoarthritis Risk After ACL Reconstruction
Knee injuries, especially those to the ACL, are common among physically active people. These injuries are frequently treated with surgical reconstruction (ACL reconstruction; ACLR). While ACLR restores stability it does not protect against future injury, long-term pain, disability, and arthritis associated with these injuries. Our study is going to examine new ways to provide feedback about the way people move to determine if these are better at modifying movement patterns that are known risk factors of posttraumatic osteoarthritis development than current standard treatments. If you participate, you will be asked to undergo a movement analysis in a research laboratory while you perform tasks such as walking and hopping. After this initial assessment, you will be randomly allocated to one of 2 treatment groups. Each treatment group will perform 4 weeks (3x/week) of exercises to change the way people walk. Participants will then report for follow-up movement analysis testing 1- and 4-weeks after completing the intervention.
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Osteo Arthritis Knee
- Being tested
- Internal focus of attention feedback, External focus of attention feedback
- 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.
Internal focus of attention feedbackOther
Participants will complete 12 sessions over a 3-week period of functional movement retraining while receiving mirror feedback. Participants will be instructed to perform each functional task in a manner that keeps their knee in line with their toes.
External focus of attention feedbackOther
Participants will complete 12 sessions over a 3-week period of functional movement retraining while receiving visual feedback via laser. Participants will be instructed to perform each functional task in a manner that does causes the laser to move up and down but not side-to-side.
| Study group | Role | What they receive |
|---|---|---|
| Internal focus of attention feedback | Active comparator | Participants will complete 12 sessions over 3 weeks receiving visual feedback in a mirror of their movement patterns. Receives: Other: Internal focus of attention feedback |
| External focus of attention feedback | Experimental | Participants will complete 12 sessions over 3 weeks receiving visual feedback of their movement patterns from a laser. Receives: Other: External focus of attention feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in lower extremity biomechanics during walking
Knee and hip angles and loads measured via 3D biomechanics
Measured: 1-week post-intervention, 4-weeks post-intervention
Knee cartilage health
Knee cartilage thickness measured using diagnostic ultrasound imaging
Measured: 1-week post-intervention, 4-weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start1 Jan 2022
- Primary completion31 May 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Charlotte
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Foundation
- Responsible party
- Principal investigator, Abbey Thomas, PhD, University of North Carolina, Charlotte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922268
- Sponsor's protocol ID
- 22-0089
- Status last verified
- Dec 2024
- First submitted
- 4 Jun 2021
- Last updated
- 24 Dec 2024
- 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 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Focus of Attention Feedback to Mitigate Posttraumatic Osteoarthritis Risk After ACL Reconstruction
- ClinicalTrials.gov ID
- NCT04922268
- Acronym / sponsor ID
- 22-0089
- Conditions
- Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Tear, Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of North Carolina, CharlotteUniversity, hospital or other
- Collaborators
- Arthritis Foundation
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 10 Jun 2021 (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.
Knee injuries, especially those to the ACL, are common among physically active people. These injuries are frequently treated with surgical reconstruction (ACL reconstruction; ACLR). While ACLR restores stability it does not protect against future injury, long-term pain, disability, and arthritis associated with these injuries. Our study is going to examine new ways to provide feedback about the way people move to determine if these are better at modifying movement patterns that are known risk factors of posttraumatic osteoarthritis development than current standard treatments. If you participate, you will be asked to undergo a movement analysis in a research laboratory while you perform tasks such as walking and hopping. After this initial assessment, you will be randomly allocated to one of 2 treatment groups. Each treatment group will perform 4 weeks (3x/week) of exercises to change the way people walk. Participants will then report for follow-up movement analysis testing 1- and 4-weeks after completing the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internal focus of attention feedback | Active comparator | Other: Internal focus of attention feedbackParticipants will complete 12 sessions over 3 weeks receiving visual feedback in a mirror of their movement patterns. |
| External focus of attention feedback | Experimental | Other: External focus of attention feedbackParticipants will complete 12 sessions over 3 weeks receiving visual feedback of their movement patterns from a laser. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- history of primary, unilateral ACL reconstruction 6-24 months prior to enrollment
- cleared to return to full activity by treating orthopedic surgeon
Key exclusion criteria (3 listed)
- Body mass index >35 kg/m2
- History of musculoskeletal injury sustained 3 months prior to enrollment
- Current participation in formal post-operative rehabilitation
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 |
|---|---|---|
| Internal focus of attention feedbackParticipants will complete 12 sessions over a 3-week period of functional movement retraining while receiving mirror feedback. Participants will be instructed to perform each functional task in a manner that keeps their knee in line with their toes. | Other | Internal focus of attention feedback |
| External focus of attention feedbackParticipants will complete 12 sessions over a 3-week period of functional movement retraining while receiving visual feedback via laser. Participants will be instructed to perform each functional task in a manner that does causes the laser to move up and down but not side-to-side. | Other | External focus of attention feedback |
Primary outcome
Changes from baseline in lower extremity biomechanics during walking
Time frame: 1-week post-intervention, 4-weeks post-intervention
Knee and hip angles and loads measured via 3D biomechanics
Knee cartilage health
Time frame: 1-week post-intervention, 4-weeks post-intervention
Knee cartilage thickness measured using diagnostic ultrasound imaging
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 24 Dec 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal focus of attention feedback and External focus of attention feedback in people with Anterior Cruciate Ligament Injuries and Anterior Cruciate Ligament Rupture, run by University of North Carolina, Charlotte at 1 site in United States.
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 3 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 24 Dec 2024. 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 United States. 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?
Changes from baseline in lower extremity biomechanics during walking (time frame: 1-week post-intervention, 4-weeks post-intervention). The study lists 2 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 24 Dec 2024.