Medial Patellar Femoral Ligament Reconstruction RehabilitationNCT05426954
BFRT MPFL and ACL Reconstruction Rehab
A study testing Rehabilitation utilizing blood flow restrictive therapy in people with Medial Patellar Femoral Ligament Reconstruction Rehabilitation and Anterior Cruciate Ligament Reconstruction Rehabilitation, run by Richard Watson, PT at 1 site in United States.
Trial summary
Blood flow restrictive (BFR) therapy following MPFL or ACL reconstruction rehabilitation. Specific Aim 1: Test whether maintaining BFR cuff inflation or deflating between exercises results in greater quadriceps strength and functional outcomes after MPFL or ACL reconstruction. Read more about this study
- Who is it for?
- Ages 13 to 40 years
- Conditions the study is for
- Medial Patellar Femoral Ligament Reconstruction Rehabilitation, Anterior Cruciate Ligament Reconstruction Rehabilitation
- What is being tested?
- Rehabilitation utilizing blood flow restrictive therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 28 Jul 2023
- 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 13 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Post operative Medial Patellar Femoral Ligament or Anterior Cruciate Ligament Reconstruction.
Who cannot join
- Had any other previous surgeries or conditions that might affect your gait prior to injury and 1 year removed from a prior ACL or MPFL reconstruction.
- Have any current lower extremity condition other than MPFL or ACL reconstruction which might affect your gait
- Have a diminished capacity to provide informed consent
- Are diabetic or have uncontrolled hypertension
- Have recent inflammation, bleeding disorders, active bleeding or infection within the lower limbs.
- You are taking warfarin/Coumadin, clopidogrel/Plavix, Rivaroxaban/Xarelto, Dabigatran/Pradaxa, apixaban/Eliquis, deoxidant/Savaysa, betrixaban, or any other anti-coagulants that may cause excess bleeding.
Show all 10Show fewer
- Have any implanted medical device
- Have a history of deep vein thrombosis, vascular graft, varicose veins, and/or sickle cell anemia
- Are or suspect you are Pregnant
- You are not be able to attend regular physical therapy or study visits
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Sports Rehabilitation
Lexington, Kentucky, 40504
About this study
Official title: Blood Flow Restrictive Training Following Medial Patellofemoral Ligament and Anterior Cruciate Ligament Reconstruction Rehabilitation
Blood flow restrictive (BFR) therapy following MPFL or ACL reconstruction rehabilitation.
Specific Aim 1: Test whether maintaining BFR cuff inflation or deflating between exercises results in greater quadriceps strength and functional outcomes after MPFL or ACL reconstruction.
Read more
Hypothesis 1: Subjects in the deflate BFR protocol group will have significantly greater quadriceps strength, symmetric leg symmetry index on a battery of functional tests and PROs as compared to the non-deflate group.
Specific Aim 2: Compare whether maintaining BFR cuff inflation or deflating between exercises results in reduced pain, improved exercise tolerance, and patient-reports outcomes (PRO) after MPFL or ACL reconstruction.
Hypothesis 2: Subjects in the deflated BFR protocol group will report significantly less pain and greater exercise tolerance during exercise with significantly improved knee related PRO scores.
Read the detailed description
Subjects will be aged 13-40 male or female patient following MPFL or ACL reconstruction.
Baseline Assessment at PT Evaluation will included knee AROM and AAROM Heel slide with strap, Knee edema measured in cm difference Involved to Non-involved at supra and mid patellar levels, subjects ability to SLR Yes/No in brace, Patient reported outcome measure (PRO's) to include LEFS, Brief Resiliency scale, MPFL - Norwich Patellar instability, ACL 2000 IKDC Subjective Knee Evaluation Form questionnaires. Pain assessment to include current, minimal and maximal pain levels past 24 hours.
Patient are randomized into 1 of 2 groups: Group 1 will deflate between BFR exercises, Group 2 will not deflate between BFR exercises. Both groups will receive the same standard care same during their first 2 weeks of post-op rehabilitation. BFR will be added to their rehabilitation care starting at week 3 for 2x/week x 10. There are 4 core BFR exercises that will be progressed every 2 weeks.
Final Assessment- Strength and Functional Testing at 24th visit or 12 weeks post-op (if missed appointments) to include bilateral Knee AROM and edema assessments, PRO's: LEFS, Brief Resiliency scale, MPFL Norwich Patellar instability, ACL 2000 IKDC Subjective Knee Evaluation Form, Functional assessment to include for involved adn uninvolved leg: Isometric Quad strength measurement at 90 degrees of knee flexion, Isometric Hip Abduction strength measurement, Y balance maximum anterior reach, Max reps 6" Forward step-down, max core strength assessments, and ability in-line jog.
- Conditions
- Medial Patellar Femoral Ligament Reconstruction Rehabilitation, Anterior Cruciate Ligament Reconstruction Rehabilitation
- Being tested
- Rehabilitation utilizing blood flow restrictive therapy
- Keywords
- rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation utilizing blood flow restrictive therapyOther
BFR therapy
| Study group | Role | What they receive |
|---|---|---|
| BFR deflate | Active comparator | BFR cuff will be deflated at the end of each of the 4 BFR exercises, BFR cuff is inflated prior to start next BFR exercise. Receives: Other: Rehabilitation utilizing blood flow restrictive therapy |
| BFR do not deflate | Active comparator | BFR cuff will not be deflated at the end of each of the 4 BFR exercises. Cuff remains inflated start exercise 1 thru completion exercise 4. Receives: Other: Rehabilitation utilizing blood flow restrictive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Isometric Knee Strength
involved vs uninvolved isometric quadriceps knee strength measured at 90 degrees flexion comparison
Measured: 24th visit or 12 weeks Post-op (if missed appointments)
Hip abduction Isometric Strength
involved vs uninvolved isometric hip abduction strength comparison
Measured: measured at the 24th visit or 12 weeks Post-op (if missed appointments)
Y Balance Anterior Reach Test
involved vs uninvolved maximum Y Anterior Reach test comparison
Measured: measured at the 24th visit or 12 weeks Post-op (if missed appointments)
Maximum 6 inch forward step down test
involved vs uninvolved maximum reps performing 6" forward step down in 1 min comparison
Measured: measured at the 24th visit or 12 weeks Post-op (if missed appointments)
Max core strength assessment
Max hold in seconds: prone plank, side planks and single leg bridge
Measured: measured at the 24th visit or 12 weeks Post-op (if missed appointments)
Ability to in-line jog
Determine if subject is able to jog in a straight line
Measured: measured at the 24th visit or 12 weeks Post-op (if missed appointments)
Lower Extremity Functional Scale (LEFS)
All subjects will complete the LEFS questionnaire which contains 20 questions about a person's ability to perform everyday tasks. The maximum possible score is 80 points, indicating very high function. The minimum possible score is 0 points, indicating very low function.
Measured: measured at PT Evaluation and 24th visit or 12 weeks Post-op (if missed appointments)
Brief Resiliency Scale
All subjects will complete the Brief Resiliency Scale which assesses the ability to bounce back. The possible score range is from 1 (low resilience) to 5 (high resilience)
Measured: measured at PT Evaluation and 24th visit or 12 weeks Post-op (if missed appointments)
Norwich Patellar Instability
MPFL reconstruction subjects will complete the Norwich Patellar Instability which assesses patellar instability symptoms. The score is made up of 0 to 250. The total score is then converted to a percentage based on the number of scored responses. A higher percentage up to maximum 100% indicates the severity of patellar instability.
Measured: measured at PT Evaluation and 24th visit or 12 weeks Post-op (if mised appointments)
2000 IKDC Subjective Knee Evaluation Form
ACL reconstruction patients with complete the 2000 IKDC Subjective Knee Evaluation Form. The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)
Measured: measured at PT Evaluation and 24th visit or 12 weeks Post-op (if missed appointments)
Secondary outcomes (2)
Discomfort level
Measurement subject report discomfort level following each BFR exercise
Measured: Measured at each treatment follwoing each BFR exercise - Specific Aim 2
Effort Level
Measurement subject report effort level following each BFR exercise
Measured: Measured at each treatment follwoing each BFR exercise - Specific Aim 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start29 Jun 2021
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medial Patellar Femoral Ligament Reconstruction RehabilitationStudies 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
- Randomized Rehabilitation
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Richard Watson, PT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Richard Watson, PT, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426954
- Sponsor's protocol ID
- 54653
- Status last verified
- May 2024
- First submitted
- 2 Jun 2022
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restrictive Training Following Medial Patellofemoral Ligament and Anterior Cruciate Ligament Reconstruction Rehabilitation
- ClinicalTrials.gov ID
- NCT05426954
- Acronym / sponsor ID
- 54653
- Conditions
- Medial Patellar Femoral Ligament Reconstruction Rehabilitation, Anterior Cruciate Ligament Reconstruction Rehabilitation
- Keywords
- rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Richard Watson, PTUniversity, hospital or other
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 22 Jun 2022 (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.
Blood flow restrictive (BFR) therapy following MPFL or ACL reconstruction rehabilitation.
Specific Aim 1: Test whether maintaining BFR cuff inflation or deflating between exercises results in greater quadriceps strength and functional outcomes after MPFL or ACL reconstruction.
Hypothesis 1: Subjects in the deflate BFR protocol group will have significantly greater quadriceps strength, symmetric leg symmetry index on a battery of functional tests and PROs as compared to the non-deflate group.
Specific Aim 2: Compare whether maintaining BFR cuff inflation or deflating between exercises results in reduced pain, improved exercise tolerance, and patient-reports outcomes (PRO) after MPFL or ACL reconstruction.
Hypothesis 2: Subjects in the deflated BFR protocol group will report significantly less pain and greater exercise tolerance during exercise with significantly improved knee related PRO scores.
Detailed description
Subjects will be aged 13-40 male or female patient following MPFL or ACL reconstruction.
Baseline Assessment at PT Evaluation will included knee AROM and AAROM Heel slide with strap, Knee edema measured in cm difference Involved to Non-involved at supra and mid patellar levels, subjects ability to SLR Yes/No in brace, Patient reported outcome measure (PRO's) to include LEFS, Brief Resiliency scale, MPFL - Norwich Patellar instability, ACL 2000 IKDC Subjective Knee Evaluation Form questionnaires. Pain assessment to include current, minimal and maximal pain levels past 24 hours.
Patient are randomized into 1 of 2 groups: Group 1 will deflate between BFR exercises, Group 2 will not deflate between BFR exercises. Both groups will receive the same standard care same during their first 2 weeks of post-op rehabilitation. BFR will be added to their rehabilitation care starting at week 3 for 2x/week x 10. There are 4 core BFR exercises that will be progressed every 2 weeks.
Final Assessment- Strength and Functional Testing at 24th visit or 12 weeks post-op (if missed appointments) to include bilateral Knee AROM and edema assessments, PRO's: LEFS, Brief Resiliency scale, MPFL Norwich Patellar instability, ACL 2000 IKDC Subjective Knee Evaluation Form, Functional assessment to include for involved adn uninvolved leg: Isometric Quad strength measurement at 90 degrees of knee flexion, Isometric Hip Abduction strength measurement, Y balance maximum anterior reach, Max reps 6" Forward step-down, max core strength assessments, and ability in-line jog.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Rehabilitation
| Arm | Type | Receives |
|---|---|---|
| BFR deflate | Active comparator | Other: Rehabilitation utilizing blood flow restrictive therapyBFR cuff will be deflated at the end of each of the 4 BFR exercises, BFR cuff is inflated prior to start next BFR exercise. |
| BFR do not deflate | Active comparator | Other: Rehabilitation utilizing blood flow restrictive therapyBFR cuff will not be deflated at the end of each of the 4 BFR exercises. Cuff remains inflated start exercise 1 thru completion exercise 4. |
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Post operative Medial Patellar Femoral Ligament or Anterior Cruciate Ligament Reconstruction.
Key exclusion criteria (10 listed)
- Had any other previous surgeries or conditions that might affect your gait prior to injury and 1 year removed from a prior ACL or MPFL reconstruction.
- Have any current lower extremity condition other than MPFL or ACL reconstruction which might affect your gait
- Have a diminished capacity to provide informed consent
- Are diabetic or have uncontrolled hypertension
- Have recent inflammation, bleeding disorders, active bleeding or infection within the lower limbs.
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 |
|---|---|---|
| Rehabilitation utilizing blood flow restrictive therapyBFR therapy | Other | BFR deflate, BFR do not deflate |
Primary outcome
Quadriceps Isometric Knee Strength
Time frame: 24th visit or 12 weeks Post-op (if missed appointments)
involved vs uninvolved isometric quadriceps knee strength measured at 90 degrees flexion comparison
Hip abduction Isometric Strength
Time frame: measured at the 24th visit or 12 weeks Post-op (if missed appointments)
involved vs uninvolved isometric hip abduction strength comparison
Y Balance Anterior Reach Test
Time frame: measured at the 24th visit or 12 weeks Post-op (if missed appointments)
involved vs uninvolved maximum Y Anterior Reach test comparison
Maximum 6 inch forward step down test
Time frame: measured at the 24th visit or 12 weeks Post-op (if missed appointments)
involved vs uninvolved maximum reps performing 6" forward step down in 1 min comparison
Max core strength assessment
Time frame: measured at the 24th visit or 12 weeks Post-op (if missed appointments)
Max hold in seconds: prone plank, side planks and single leg bridge
Ability to in-line jog
Time frame: measured at the 24th visit or 12 weeks Post-op (if missed appointments)
Determine if subject is able to jog in a straight line
Lower Extremity Functional Scale (LEFS)
Time frame: measured at PT Evaluation and 24th visit or 12 weeks Post-op (if missed appointments)
All subjects will complete the LEFS questionnaire which contains 20 questions about a person's ability to perform everyday tasks. The maximum possible score is 80 points, indicating very high function. The minimum possible score is 0 points, indicating very low function.
Brief Resiliency Scale
Time frame: measured at PT Evaluation and 24th visit or 12 weeks Post-op (if missed appointments)
All subjects will complete the Brief Resiliency Scale which assesses the ability to bounce back. The possible score range is from 1 (low resilience) to 5 (high resilience)
Norwich Patellar Instability
Time frame: measured at PT Evaluation and 24th visit or 12 weeks Post-op (if mised appointments)
MPFL reconstruction subjects will complete the Norwich Patellar Instability which assesses patellar instability symptoms. The score is made up of 0 to 250. The total score is then converted to a percentage based on the number of scored responses. A higher percentage up to maximum 100% indicates the severity of patellar instability.
2000 IKDC Subjective Knee Evaluation Form
Time frame: measured at PT Evaluation and 24th visit or 12 weeks Post-op (if missed appointments)
ACL reconstruction patients with complete the 2000 IKDC Subjective Knee Evaluation Form. The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms)
2 secondary outcomes
Discomfort level
Time frame: Measured at each treatment follwoing each BFR exercise - Specific Aim 2
Effort Level
Time frame: Measured at each treatment follwoing each BFR exercise - Specific Aim 2
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 17 May 2024.
- Individual participant dataSharing planned: Undecided
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 Rehabilitation utilizing blood flow restrictive therapy in people with Medial Patellar Femoral Ligament Reconstruction Rehabilitation and Anterior Cruciate Ligament Reconstruction Rehabilitation, run by Richard Watson, PT 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 1 inclusion and 10 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 17 May 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?
Quadriceps Isometric Knee Strength (time frame: 24th visit or 12 weeks Post-op (if missed appointments)). The study lists 10 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 17 May 2024.