Anterior Cruciate Ligament InjuryNCT03273673
Reduction of Risk Factors for ACL Re-injuries Using a Novel Biofeedback Approach
A study testing Biofeedback Intervention in people with Anterior Cruciate Ligament Injury, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
ACL injuries are common among athletes and due to residual muscle weakness, limited knee motion and asymmetrical movement patterns after surgery many of these athletes will sustain secondary ACL injuries following return to sports. Read more about this study
- Who is it for?
- Ages 14 to 21 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- Biofeedback Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2018to 5 May 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Provision of signed and dated informed consent form
- ACL Reconstruction: primary, unilateral ACL reconstruction with no pain in the contralateral leg
- Rehabilitation: need to have completed at least 4.5 months of post-operative physical therapy and be within approximately 6 weeks of being ready to be released by his/her treating orthopaedic surgeon to return to full sport participation
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 14-21
- Willing to adhere to the ACL Biofeedback intervention regimen
Who cannot join
- For females: currently pregnant or planning to become pregnant
- History of more than one ACL reconstruction
- Post-operative complications that required additional surgical intervention
- Hospitalization for any reason other than the ACL reconstruction in the last 3 months
- Plans for additional surgical procedures in the next 12 months
- Live greater than 60 miles from the research lab
Show all 15Show fewer
- Have limitations that would prevent them from attending the biofeedback training sessions
- Motor neuron diseases, Parkinson's disease, multiple sclerosis
- Severely impaired hearing or speech (patients must be able to respond to phone calls)
- No access to a telephone
- Participating in another ACL intervention
- Inability to understand or speak English (since this will be required for the patient-based intervention)
- Other self-reported medical problem that would prohibit participation in the study
- Other health condition or personal issue judged by a study team member or primary care physician to make the patient inappropriate for study participation
- Knee extension moment limb symmetry index (LSI) greater than or equal to 90% at the time of the initial study assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Tech - Kevin P. Granata Biomechanics Lab
Blacksburg, Virginia, 24060
About this study
Official title: Reduction of Risk Factors for ACL Re-injuries Using an Innovative Biofeedback Approach
ACL injuries are common among athletes and due to residual muscle weakness, limited knee motion and asymmetrical movement patterns after surgery many of these athletes will sustain secondary ACL injuries following return to sports. This project seeks to determine if a novel biofeedback-based rehabilitation approach can decrease a known risk factor for secondary injuries to the ACL. The project specifically focuses on correcting asymmetric movement patterns, a known risk factor for secondary injury that is not directly addressed by existing interventions through a 6 week therapy based biofeedback intervention.
Read the detailed description
Nearly 1 in 60 adolescent athletes will suffer ACL injuries. Approximately 90% of these injured athletes will undergo an ACL reconstruction at an estimated annual cost of $3 billion. While reconstruction and subsequent rehabilitation allow these athletes to return to sports, they have a 15 fold increased risk of secondary ACL injuries, a tear of the ACL graft or the contralateral ACL. As a result, development of an intervention to reduce the incidence of secondary ACL tears would meet a critical need. One area in which existing interventions might be improved is through an increased emphasis on correcting asymmetric movement patterns-a known risk factor for secondary injury. Thus, our long-term objective is to decrease the number of secondary ACL tears by decreasing side-to-side movement and loading asymmetry. The modification of post-operative rehabilitation to focus on movement and loading symmetry with shift the rehabilitation paradigm. Specifically, we propose to evaluate a novel biofeedback training program that focuses on altering loading and movement patterns to improve symmetry and overall lower extremity mechanics in a group of 40 (20 control, 20 intervention) adolescent ACL reconstructed patients. There are two core hypotheses of this study: 1) biofeedback training will decrease known risk factors for secondary ACL injuries immediately following the biofeedback program and these changes will be retained 6 week after the completion of the biofeedback program; and 2) we will be able to recruit and enroll 40 patients and retain 80% of the patients through the end of the follow-up assessment demonstrating the feasibility of the biofeedback intervention. Implementation of a biofeedback program prior to returning to dynamic athletic activities could improve physical performance outcomes, decrease secondary injury risk factors and ultimately decrease the long-term joint degeneration and development of osteoarthritis that has been associated with ACL reconstruction. Ultimately this work will lead to additional investigations to definitively determine the impact of this novel biofeedback program, which could shift the post-operative rehabilitation paradigm following ACL reconstruction to improve long-term joint health in these adolescent patients.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- Biofeedback Intervention
- Keywords
- Secondary ACL Injury Prevention, Visual Biofeedback, Tactile Biofeedback
- 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.
Biofeedback InterventionOther
Visual and Tactile Biofeedback
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback Intervention | Experimental | The 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue. Receives: Other: Biofeedback Intervention |
| Control | No intervention | The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Knee Extension Moment Symmetry
The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task
Measured: Baseline (week 0) and Post-intervention (week 6)
Change in Peak Knee Extension Moment Symmetry
The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task
Measured: Post-intervention (week 6) and Retention (week 12)
Secondary outcomes (4)
Change in Frontal Plane Knee Range of Motion
The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task
Measured: Baseline (week 0) and Post-intervention (week 6)
Change in Frontal Plane Knee Range of Motion
The frontal plane knee range of motion will be assessed during the first landing of a stop-jump task
Measured: Post-intervention (week 6) and Retention (week 12)
Change in Peak Vertical Ground Reaction Force Symmetry
The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task
Measured: Baseline (week 0) and Post-intervention (week 6)
Change in Peak Vertical Ground Reaction Force Symmetry
The peak vertical ground reaction force symmetry will be assessed during the first landing of a stop-jump task
Measured: Post-intervention (week 6) and Retention (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start20 Mar 2018
- Primary completion5 May 2020
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies 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
- Model description
- This study involves one active intervention group and an attention control group
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Robin Queen, Virginia Polytechnic Institute and State University
- Investigators
- Robin M Queen, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273673
- Sponsor's protocol ID
- 17-007
- Other IDs
- R21AR069865-01A1
- Status last verified
- Dec 2020
- First submitted
- 1 Sep 2017
- Last updated
- 4 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Peebles AT, Miller TK, Savla J, Ollendick T, Messier SP, Queen RM. Reduction of risk factors for ACL Re-injuries using an innovative biofeedback approach: A phase I randomized clinical trial. Phys Ther Sport. 2022 Sep;57:78-88. doi: 10.1016/j.ptsp.2022.07.007. Epub 2022 Jul 16.
PubMed 35940085
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Risk Factors for ACL Re-injuries Using an Innovative Biofeedback Approach
- ClinicalTrials.gov ID
- NCT03273673
- Acronym / sponsor ID
- 17-007
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- Secondary ACL Injury Prevention, Visual Biofeedback, Tactile Biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 20 Mar 2018 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Posted 4 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ACL injuries are common among athletes and due to residual muscle weakness, limited knee motion and asymmetrical movement patterns after surgery many of these athletes will sustain secondary ACL injuries following return to sports. This project seeks to determine if a novel biofeedback-based rehabilitation approach can decrease a known risk factor for secondary injuries to the ACL. The project specifically focuses on correcting asymmetric movement patterns, a known risk factor for secondary injury that is not directly addressed by existing interventions through a 6 week therapy based biofeedback intervention.
Detailed description
Nearly 1 in 60 adolescent athletes will suffer ACL injuries. Approximately 90% of these injured athletes will undergo an ACL reconstruction at an estimated annual cost of $3 billion. While reconstruction and subsequent rehabilitation allow these athletes to return to sports, they have a 15 fold increased risk of secondary ACL injuries, a tear of the ACL graft or the contralateral ACL. As a result, development of an intervention to reduce the incidence of secondary ACL tears would meet a critical need. One area in which existing interventions might be improved is through an increased emphasis on correcting asymmetric movement patterns-a known risk factor for secondary injury. Thus, our long-term objective is to decrease the number of secondary ACL tears by decreasing side-to-side movement and loading asymmetry. The modification of post-operative rehabilitation to focus on movement and loading symmetry with shift the rehabilitation paradigm. Specifically, we propose to evaluate a novel biofeedback training program that focuses on altering loading and movement patterns to improve symmetry and overall lower extremity mechanics in a group of 40 (20 control, 20 intervention) adolescent ACL reconstructed patients. There are two core hypotheses of this study: 1) biofeedback training will decrease known risk factors for secondary ACL injuries immediately following the biofeedback program and these changes will be retained 6 week after the completion of the biofeedback program; and 2) we will be able to recruit and enroll 40 patients and retain 80% of the patients through the end of the follow-up assessment demonstrating the feasibility of the biofeedback intervention. Implementation of a biofeedback program prior to returning to dynamic athletic activities could improve physical performance outcomes, decrease secondary injury risk factors and ultimately decrease the long-term joint degeneration and development of osteoarthritis that has been associated with ACL reconstruction. Ultimately this work will lead to additional investigations to definitively determine the impact of this novel biofeedback program, which could shift the post-operative rehabilitation paradigm following ACL reconstruction to improve long-term joint health in these adolescent patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This study involves one active intervention group and an attention control group
| Arm | Type | Receives |
|---|---|---|
| Biofeedback Intervention | Experimental | Other: Biofeedback InterventionThe 6-week biofeedback training program is focused on altering loading and movement asymmetry during biweekly sessions on non-consecutive days (12 sessions). The biofeedback training program will provide sensory (visual and tactile) feedback to the subject to heighten awareness of asymmetrical movement strategies (e.g. load shift, movement asymmetry) during a squat. The two exercises that will be completed during the biofeedback training program will be a visual feedback squat and a resisted squat (tactile feedback). Each of these tasks will be completed 30 (3 sets of 10 repetitions) times per session. We will provide a 20 second rest between trials, and a 10 minute break between the visual and tactile feedback exercises to decrease the effect of fatigue. |
| Control | No intervention | –The 6-week attention control group program will focus on providing educational information to the participants related to the clinical and sports expectations as they are released to return to sport. These participants will be asked to meet 6 times during the 6-week intervention time period. Three of these visits will be completed in person and three will be completed using an online educational module (6 sessions). The online sessions will be completed in week 1, week 3, and week 5 while the in person sessions will be completed during week 2, week 4, and week 6. |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form
- ACL Reconstruction: primary, unilateral ACL reconstruction with no pain in the contralateral leg
- Rehabilitation: need to have completed at least 4.5 months of post-operative physical therapy and be within approximately 6 weeks of being ready to be released by his/her treating orthopaedic surgeon to return to full sport participation
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 14-21
Key exclusion criteria (15 listed)
- For females: currently pregnant or planning to become pregnant
- History of more than one ACL reconstruction
- Post-operative complications that required additional surgical intervention
- Hospitalization for any reason other than the ACL reconstruction in the last 3 months
- Plans for additional surgical procedures in the next 12 months
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 |
|---|---|---|
| Biofeedback InterventionVisual and Tactile Biofeedback | Other | Biofeedback Intervention |
Primary outcome
Change in Peak Knee Extension Moment Symmetry
Time frame: Baseline (week 0) and Post-intervention (week 6)
The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task
Change in Peak Knee Extension Moment Symmetry
Time frame: Post-intervention (week 6) and Retention (week 12)
The peak knee extension moment asymmetry will be assessed during the first landing of a stop-jump task
4 secondary outcomes
Change in Frontal Plane Knee Range of Motion
Time frame: Baseline (week 0) and Post-intervention (week 6)
Change in Frontal Plane Knee Range of Motion
Time frame: Post-intervention (week 6) and Retention (week 12)
Change in Peak Vertical Ground Reaction Force Symmetry
Time frame: Baseline (week 0) and Post-intervention (week 6)
Change in Peak Vertical Ground Reaction Force Symmetry
Time frame: Post-intervention (week 6) and Retention (week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35940085Peebles AT, Miller TK, Savla J, Ollendick T, Messier SP, Queen RM. Reduction of risk factors for ACL Re-injuries using an innovative biofeedback approach: A phase I randomized clinical trial. Phys Ther Sport. 2022 Sep;57:78-88. doi: 10.1016/j.ptsp.2022.07.007. Epub 2022 Jul 16.
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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.
Robin M Queen, PhD principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback Intervention in people with Anterior Cruciate Ligament Injury, run by Virginia Polytechnic Institute and State University 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 6 inclusion and 15 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 4 Dec 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 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?
Yes. Results are posted in the registry (first posted 4 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Peak Knee Extension Moment Symmetry (time frame: Baseline (week 0) and Post-intervention (week 6)). 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?
On the ClinicalTrials.gov record for NCT03273673, which also lists 1 linked publication.
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 4 Dec 2020.