Osteoarthritis, KneeNCT03776981
Core Activation and Stabilization for Knee OA
A study testing Core Activation and Core Stabilization in people with Osteoarthritis, Knee, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial summary
This will be the second investigation by the PI and sub-investigator on this topic, following the promising results of a pilot study on a small sample size (N=5) completed last year. Whether or not core stabilization influences gait impairments in patients with KOA remains to be seen. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Core Activation and Core Stabilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2019to 11 Dec 2019
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English-speaking men and women
- 40 years old and older
- any race or ethnic group
- a documented diagnosis from a medical provider (i.e., physician, physician assistant, or nurse practitioner, etc.) of KOA, unilaterally or bilaterally.
- Previous or current physical therapy patients may be included (see exclusion criteria for exceptions).
- Healthy controls will meet the same requirements, but:
- without a medical diagnosis of KOA
- have the ability to ambulate on a level surface without any report of pain in their knees at the time of gait assessment.
Who cannot join
- Those with other lower extremity injuries (orthopaedic, cardiovascular, neurologic, etc.) which are currently hindering their ability to ambulate
- those with current complaints of low back pain
- those who have undergone bilateral total knee arthroplasty
- those with concomitant diagnosis of rheumatoid arthritis
- those persons not able to ambulate independently with or without an assistive device
- those who have received a corticosteroid injection within the past two months
- those who have received a hyaluronic acid injection in the past six months
- those persons currently enrolled in a core training program as part of formal physical therapy or physical fitness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130
About this study
Official title: The Effects of Core Activation and Stabilization Training on Gait Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients With Knee Osteoarthritis
This will be the second investigation by the PI and sub-investigator on this topic, following the promising results of a pilot study on a small sample size (N=5) completed last year. Whether or not core stabilization influences gait impairments in patients with KOA remains to be seen. Core stabilization has been shown to have positive effects, including increased stride velocity and scores on functional tests like the Functional Reach Test and Timed Up and Go, in older adults. Older adults were also shown to have high compliance with a core stability training program. A systematic review indicated that core training is important to consider when treating older individuals to improve functional use of the extremities, improving participation in activities of daily living, and as part of a fall prevention program. Additionally, it has been shown to benefit young, active individuals in preventing anterior cruciate ligament injury and greater duration of improved outcomes in patients with patellofemoral pain syndrome. Athletes with decreased core control have been shown to be at an increased risk of knee injury as well. One potential cause for this is the ability of the core to improve lower extremity kinematics when activated during challenging single leg weight bearing activity. A recent publication by Azuma, et al. did indicate that paraspinal and anterior abdominal thinning had a negative predictive relationship to the presence of KOA; however, no investigation has explored a cause and effect relationship between core stability/stabilization training and the presence or severity of KOA, nor the gait and functional ability of patients with KOA. This later concept is the focus of this investigation.
Read the detailed description
Unpublished pilot data collected by the same PI and sub-investigator shows that volitional activation of the TA during self-selected paced ambulation significantly decreases the time to first peak ground reaction force (T1) in the sagittal plane in participants with KOA (D.W. Flowers, C. Frilot, unpublished data, May 2018). This same kinetic gait variable is included in this investigation as one of the dependent variables in all three parts of the investigation.
Nearly four percent of the global population has KOA, with the global female percentage nearing five percent. Additionally, the years lived with disability (YLDs) resulting from the disorder increased by 64.8% from 1990 to 2010. The picture is not much better in the United States, where osteoarthritis ranks eighth highest in YLDs compared to other pathologies. The rate of KOA has continued to climb here in the U.S., doubling in the past half-century even when accounting for increased life expectancy and higher average BMI, both of which are considered risk factors in the development of KOA.
Patients with KOA have been shown to have gait abnormalities when compared to healthy controls, including alterations in trunk and pelvic kinematics, lower extremity kinematics and kinetics, gait speed, and functional outcome measure scores. Some of these differences, like an increased external knee adduction moment (KAM) and a decreased peak stance knee flexion angle (KFA), have been shown to correlate with the advancement of KOA and may be causative in nature. Others, like an increased T1 and reduced freely chosen gait speed, may be compensatory. The same has been found in regard to the reduced second peak ground reaction force in the sagittal plane (F2) observed in this population.
Reduced gait speed alone is predictive of increased fall risk in older adults, without any need to consider additional activities performed during walking tasks. Additionally, the gait impairments observed in this population can be so extreme that they can be more limiting than those observed in patients with diagnoses typically considered more severe, like congestive heart failure, diabetes, heart disease, and stroke. Therefore, improving function via improving gait speed via novel approaches is indicated, but not at the expense of increasing wear and tear on osteoarthritic joints. This investigation aims to show that core stabilization, which has been shown beneficially influence the kinetics and kinematics of lower extremity movements in younger, more active populations, can serve the same purpose in a population with KOA. The investigators are specifically trying to improve self-perceived function and gait speed, via improving the kinetics and kinematics observed in self-selected ambulation.
This investigation will be divided into three parts, each associated with one of the specific aims detailed in Section 1. All procedures will be performed in the School of Allied Health Professions, either in the Motion Analysis Laboratory (Gait Lab) or the Rehabilitation Faculty Practice (RFP) Clinic.
Part 1: Compare age and gender matched healthy controls and KOA groups on kinetics, kinematics, and gait speed during self-selected speed via a between groups analysis across the dependent variables, and determine if those differences in the KOA group have a predictive relationship with their KOOS scores.
Part 2: Within-group comparison of both groups (with and without volitional TA activation) and between-groups (control group versus KOA group). Compare pain levels during both conditions via VAS for the KOA group. Participants will wear biofeedback under both conditions, and all condition trials will be randomized. Alarm or verbal cue will be provided at 30% MVIC, and two electrodes placed over TA/obliquus internus (OI) just medial to anterior superior iliac spine (ASIS). A comparison of TA activation will be performed both within and between groups.
Part 3: Within-groups comparison of KOA group (pre-treatment and post-treatment; six-week training program) on kinetics, kinematics, and gait speed during self-selected paced ambulation. A comparison of KOOS scores before and after treatment with be performed as well.
Once recruitment and informed consent are completed:
Part 1: All participants will undergo anthropometric data collection first, including weight, height, leg length, knee joint width, and ankle joint width. Age matching will be done within +/- 5 years between the two groups. Reflective markers will then be placed on bilateral lower extremities following the Plug in Gait Model. EMG electrodes will be placed bilaterally just medial to the ASIS, over the TA/OI. The Gait Lab will undergo calibration, and the participant will undergo a static trial. In participants with bilateral KOA, the most painful limb, identified by subjective report, will be used in the data collection procedures. Healthy controls will undergo analysis of their dominant limb by indicating with which leg they would kick a ball.
Once the set-up and calibration are completed, the data collection will begin. The participant will be allowed a brief warm-up of 1-2 minutes, walking in the Gait Lab prior to data collection commences. The participant will then be asked to walk at a self-selected pace across the capture area until three trials with good force plate contact are obtained. Good force plate contact is defined as initial contact at the heel and pre-swing/toe off occurring on the force plate, and the absence of any evidence of distraction via the video cameras, such as the participant talking or looking around the lab. These three trials will be used in the kinetic, kinematic, and gait speed data analysis.
See Part 2 for additional trials that will be performed concurrently for both groups. Participants in the experimental group will also be asked to complete a KOOS questionnaire at the same time.
Part 2: Participants will undergo the same procedures described in Part 1 above. While the three trials are obtained for Part 1, three additional walking trials will be concurrently collected for the both groups. These will include the participant volitionally activating their TA during the walking trials, performed and screened exactly the same as in Part 1. These trials will be performed with and without audible biofeedback (via an alarm or verbal cueing), indicating the TA meeting the threshold subsequently discussed below. Investigators will randomly determine whether the trials with or without volitional TA activation are performed first (i.e., Part 1 versus Part 2 trials). The randomization done for Part 2 to determine whether or not the without (Part 1) or with (Part 2) volitional TA activation trials are performed first will be determined via random number generation between 0 and 1 in Excel. Those with 0 will perform the without volitional TA (Part 1) trials first, while those with 1 will perform the with volitional TA activation trials (Part 2) first.
The patient will lie supine on the mat in the lab and will be taught how to perform a TA contraction. Please see the attached script with the instructions that will be used in this education. A baseline maximal contraction will be performed supine, and the amplitude of contraction will be considered maximal voluntary isometric contraction (MVIC). The device will be set to provide audible feedback, or the participant will receive a verbal cue from the investigator, at 30% MVIC. This feedback will be randomized throughout the trials with TA activation via random number generation in Excel, with 0 signifying no cue and 1 indicating a cue. The task will be repeated seated, then standing, prior to data collection.
The experimental group, during both sets of trials, will be asked to subjectively rate their perceived pain in the lower extremity being used in data collection via a 10-point scale, typically used on the VAS, although no visual will be used. Please see the supplemental script document attached to this protocol for the instructions used.
Part 3: Participants in the experimental group will participate in a six-week core stabilization intervention program. Please see the attached intervention program. This program will commence as soon as possible after Parts 1 and 2 of the investigation are completed. Participants will participate in two scheduled intervention sessions each week. Additionally, there will be a home exercise program, consisting of exercises from each week to be performed at home independently. Participants will be provided education and a handout on these exercises by the PI, which will include directions, photographs of the exercises, and a completion check-off for each session. These will be performed three times per week, every other day. The PI will be coordinator of the scheduling and performance of these interventions. These intervention sessions will be performed in the RFP Clinic in the SAHP, either in the open gym or in a private treatment room. This decision will be left up to the participant. More than one participant may or may not undergo intervention with the PI simultaneously, but only with the participants' consent. No more than three participants will undergo the training simultaneously. Training sessions will not be performed on consecutive days in an effort to reduce the chances of delayed onset muscle soreness being present during treatment sessions. Additionally, the core training program includes predetermined guidelines on exercise progressions in order to ensure that the exercises are not progressed too rapidly. The PI will be present and will lead all sessions, ensuring that the exercises and their progressions are done correctly.
After the completion of the intervention program, each participant will undergo gait analysis in the same manner mentioned in Part 1, with the exception of no anthropometric data being collected. Participants will then complete a second, post-intervention KOOS questionnaire, and turn in their home exercise program sheet with tallies from completed sessions. Please see Part 1 for completion of the pre-intervention KOOS questionnaire.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Core Activation, Core Stabilization
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core ActivationOther
Volitional activation of the transversus abdominis muscle during self-selected paced ambulation for both groups.
Core StabilizationOther
Six-week core stabilization program for the group of participants with knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| Baseline Gait Comparisons of Groups | No intervention | Determine if kinetic (time to first peak ground reaction force [T1] and second peak ground reaction force [F2], both in the sagittal plane) and kinematic (peak stance knee flexion angle [KFA] and external knee adduction moment [KAM]) gait variables, and speed, differ between patients with KOA and age and gender matched controls during self-selected paced ambulation, and determine which ones have predictive relationships with Knee Injury and Osteoarthritis Outcome Score (KOOS) scores in the patients with KOA. |
| Gait with core activation | Experimental | Determine if volitional core activation alters gait kinetics (T1 and F2), kinematics (KFA and KAM), and speed in patients with and without KOA during self-selected paced ambulation when compared to ambulating without volitional core activation, and whether the subjective pain complaints are significantly changed in the group with KOA. Determine whether there are baseline differences in core activation between those with and without KOA. Receives: Other: Core Activation |
| Knee OA Gait After core stabilization | Experimental | Determine if a six-week core stabilization program alters KOOS score, and the kinetics (T1 and F2), kinematics (KFA and KAM), and speed of gait in patients with KOA during self-selected paced ambulation as compared to their pre-intervention baselines. Determine if there is a predictive relationship between the number of completed intervention sessions performed and these observed changes. Receives: Other: Core Stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Peak Ground Reaction Force in the Sagittal Plane (T1)
Kinetic variable observed during gait analysis.
Measured: Through study completion, on average about 1 year.
Second Peak Ground Reaction Force in the Sagittal Plane (F2)
Kinetic variable observed during gait analysis.
Measured: Through study completion, on average about 1 year.
Peak Stance Knee Flexion Angle (KFA)
Kinematic variable observed during gait analysis.
Measured: Through study completion, on average about 1 year.
External Knee Adduction Moment (KAM)
Kinematic variable observed during gait analysis.
Measured: Through study completion, on average about 1 year.
Gait Speed
Self-selected gait velocity of each participant during gait analysis.
Measured: Through study completion, on average about 1 year.
Secondary outcomes (3)
Pain Rating on Visual Analog Scale (VAS)
Self-perceived rating of pain related by participants.
Measured: Through study completion, on average about 1 year.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Outcome measure for self-perceived function in patients with knee osteoarthritis.
Measured: Through study completion, on average about 1 year.
Transversus Abdominis Activation
Transversus abdominis activity as measured via electromyography.
Measured: Through study completion, on average about 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start8 Jan 2019
- Primary completion11 Dec 2019
- Study completion11 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Woman's University
- Responsible party
- Sponsor
- Investigators
- Daniel W Flowers, DPT, Principal investigator, Louisiana State University Health Sciences Center Shreveport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776981
- Sponsor's protocol ID
- STUDY00001065
- Other IDs
- Study #20344
- Status last verified
- Feb 2020
- First submitted
- 12 Dec 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Granacher U, Lacroix A, Muehlbauer T, Roettger K, Gollhofer A. Effects of core instability strength training on trunk muscle strength, spinal mobility, dynamic balance and functional mobility in older adults. Gerontology. 2013;59(2):105-13. doi: 10.1159/000343152. Epub 2012 Oct 24.
PubMed 23108436Granacher U, Gollhofer A, Hortobagyi T, Kressig RW, Muehlbauer T. The importance of trunk muscle strength for balance, functional performance, and fall prevention in seniors: a systematic review. Sports Med. 2013 Jul;43(7):627-41. doi: 10.1007/s40279-013-0041-1.
PubMed 23568373Whyte EF, Richter C, O'Connor S, Moran KA. Effects of a dynamic core stability program on the biomechanics of cutting maneuvers: A randomized controlled trial. Scand J Med Sci Sports. 2018 Feb;28(2):452-462. doi: 10.1111/sms.12931. Epub 2017 Jul 13.
PubMed 28605148Ferber R, Bolgla L, Earl-Boehm JE, Emery C, Hamstra-Wright K. Strengthening of the hip and core versus knee muscles for the treatment of patellofemoral pain: a multicenter randomized controlled trial. J Athl Train. 2015 Apr;50(4):366-77. doi: 10.4085/1062-6050-49.3.70. Epub 2014 Nov 3.
PubMed 25365133Zazulak BT, Hewett TE, Reeves NP, Goldberg B, Cholewicki J. Deficits in neuromuscular control of the trunk predict knee injury risk: a prospective biomechanical-epidemiologic study. Am J Sports Med. 2007 Jul;35(7):1123-30. doi: 10.1177/0363546507301585. Epub 2007 Apr 27.
PubMed 17468378Shirey M, Hurlbutt M, Johansen N, King GW, Wilkinson SG, Hoover DL. The influence of core musculature engagement on hip and knee kinematics in women during a single leg squat. Int J Sports Phys Ther. 2012 Feb;7(1):1-12.
PubMed 22319676Azuma K, Sera Y, Shinjo T, Takayama M, Shiomi E, Momoshima S, Iwao Y, Ishida H, Matsumoto H. Maintenance of the paraspinal muscles may protect against radiographic knee osteoarthritis. Open Access Rheumatol. 2017 Aug 10;9:151-158. doi: 10.2147/OARRR.S130688. eCollection 2017.
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PubMed 23182814
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Core Activation and Stabilization Training on Gait Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03776981
- Acronym / sponsor ID
- STUDY00001065
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Collaborators
- Texas Woman's University
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 11 Dec 2019 (actual)
- Study completion
- 11 Dec 2019 (actual)
- First posted
- 17 Dec 2018 (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.
This will be the second investigation by the PI and sub-investigator on this topic, following the promising results of a pilot study on a small sample size (N=5) completed last year. Whether or not core stabilization influences gait impairments in patients with KOA remains to be seen. Core stabilization has been shown to have positive effects, including increased stride velocity and scores on functional tests like the Functional Reach Test and Timed Up and Go, in older adults. Older adults were also shown to have high compliance with a core stability training program. A systematic review indicated that core training is important to consider when treating older individuals to improve functional use of the extremities, improving participation in activities of daily living, and as part of a fall prevention program. Additionally, it has been shown to benefit young, active individuals in preventing anterior cruciate ligament injury and greater duration of improved outcomes in patients with patellofemoral pain syndrome. Athletes with decreased core control have been shown to be at an increased risk of knee injury as well. One potential cause for this is the ability of the core to improve lower extremity kinematics when activated during challenging single leg weight bearing activity. A recent publication by Azuma, et al. did indicate that paraspinal and anterior abdominal thinning had a negative predictive relationship to the presence of KOA; however, no investigation has explored a cause and effect relationship between core stability/stabilization training and the presence or severity of KOA, nor the gait and functional ability of patients with KOA. This later concept is the focus of this investigation.
Detailed description
Unpublished pilot data collected by the same PI and sub-investigator shows that volitional activation of the TA during self-selected paced ambulation significantly decreases the time to first peak ground reaction force (T1) in the sagittal plane in participants with KOA (D.W. Flowers, C. Frilot, unpublished data, May 2018). This same kinetic gait variable is included in this investigation as one of the dependent variables in all three parts of the investigation.
Nearly four percent of the global population has KOA, with the global female percentage nearing five percent. Additionally, the years lived with disability (YLDs) resulting from the disorder increased by 64.8% from 1990 to 2010. The picture is not much better in the United States, where osteoarthritis ranks eighth highest in YLDs compared to other pathologies. The rate of KOA has continued to climb here in the U.S., doubling in the past half-century even when accounting for increased life expectancy and higher average BMI, both of which are considered risk factors in the development of KOA.
Patients with KOA have been shown to have gait abnormalities when compared to healthy controls, including alterations in trunk and pelvic kinematics, lower extremity kinematics and kinetics, gait speed, and functional outcome measure scores. Some of these differences, like an increased external knee adduction moment (KAM) and a decreased peak stance knee flexion angle (KFA), have been shown to correlate with the advancement of KOA and may be causative in nature. Others, like an increased T1 and reduced freely chosen gait speed, may be compensatory. The same has been found in regard to the reduced second peak ground reaction force in the sagittal plane (F2) observed in this population.
Reduced gait speed alone is predictive of increased fall risk in older adults, without any need to consider additional activities performed during walking tasks. Additionally, the gait impairments observed in this population can be so extreme that they can be more limiting than those observed in patients with diagnoses typically considered more severe, like congestive heart failure, diabetes, heart disease, and stroke. Therefore, improving function via improving gait speed via novel approaches is indicated, but not at the expense of increasing wear and tear on osteoarthritic joints. This investigation aims to show that core stabilization, which has been shown beneficially influence the kinetics and kinematics of lower extremity movements in younger, more active populations, can serve the same purpose in a population with KOA. The investigators are specifically trying to improve self-perceived function and gait speed, via improving the kinetics and kinematics observed in self-selected ambulation.
This investigation will be divided into three parts, each associated with one of the specific aims detailed in Section 1. All procedures will be performed in the School of Allied Health Professions, either in the Motion Analysis Laboratory (Gait Lab) or the Rehabilitation Faculty Practice (RFP) Clinic.
Part 1: Compare age and gender matched healthy controls and KOA groups on kinetics, kinematics, and gait speed during self-selected speed via a between groups analysis across the dependent variables, and determine if those differences in the KOA group have a predictive relationship with their KOOS scores.
Part 2: Within-group comparison of both groups (with and without volitional TA activation) and between-groups (control group versus KOA group). Compare pain levels during both conditions via VAS for the KOA group. Participants will wear biofeedback under both conditions, and all condition trials will be randomized. Alarm or verbal cue will be provided at 30% MVIC, and two electrodes placed over TA/obliquus internus (OI) just medial to anterior superior iliac spine (ASIS). A comparison of TA activation will be performed both within and between groups.
Part 3: Within-groups comparison of KOA group (pre-treatment and post-treatment; six-week training program) on kinetics, kinematics, and gait speed during self-selected paced ambulation. A comparison of KOOS scores before and after treatment with be performed as well.
Once recruitment and informed consent are completed:
Part 1: All participants will undergo anthropometric data collection first, including weight, height, leg length, knee joint width, and ankle joint width. Age matching will be done within +/- 5 years between the two groups. Reflective markers will then be placed on bilateral lower extremities following the Plug in Gait Model. EMG electrodes will be placed bilaterally just medial to the ASIS, over the TA/OI. The Gait Lab will undergo calibration, and the participant will undergo a static trial. In participants with bilateral KOA, the most painful limb, identified by subjective report, will be used in the data collection procedures. Healthy controls will undergo analysis of their dominant limb by indicating with which leg they would kick a ball.
Once the set-up and calibration are completed, the data collection will begin. The participant will be allowed a brief warm-up of 1-2 minutes, walking in the Gait Lab prior to data collection commences. The participant will then be asked to walk at a self-selected pace across the capture area until three trials with good force plate contact are obtained. Good force plate contact is defined as initial contact at the heel and pre-swing/toe off occurring on the force plate, and the absence of any evidence of distraction via the video cameras, such as the participant talking or looking around the lab. These three trials will be used in the kinetic, kinematic, and gait speed data analysis.
See Part 2 for additional trials that will be performed concurrently for both groups. Participants in the experimental group will also be asked to complete a KOOS questionnaire at the same time.
Part 2: Participants will undergo the same procedures described in Part 1 above. While the three trials are obtained for Part 1, three additional walking trials will be concurrently collected for the both groups. These will include the participant volitionally activating their TA during the walking trials, performed and screened exactly the same as in Part 1. These trials will be performed with and without audible biofeedback (via an alarm or verbal cueing), indicating the TA meeting the threshold subsequently discussed below. Investigators will randomly determine whether the trials with or without volitional TA activation are performed first (i.e., Part 1 versus Part 2 trials). The randomization done for Part 2 to determine whether or not the without (Part 1) or with (Part 2) volitional TA activation trials are performed first will be determined via random number generation between 0 and 1 in Excel. Those with 0 will perform the without volitional TA (Part 1) trials first, while those with 1 will perform the with volitional TA activation trials (Part 2) first.
The patient will lie supine on the mat in the lab and will be taught how to perform a TA contraction. Please see the attached script with the instructions that will be used in this education. A baseline maximal contraction will be performed supine, and the amplitude of contraction will be considered maximal voluntary isometric contraction (MVIC). The device will be set to provide audible feedback, or the participant will receive a verbal cue from the investigator, at 30% MVIC. This feedback will be randomized throughout the trials with TA activation via random number generation in Excel, with 0 signifying no cue and 1 indicating a cue. The task will be repeated seated, then standing, prior to data collection.
The experimental group, during both sets of trials, will be asked to subjectively rate their perceived pain in the lower extremity being used in data collection via a 10-point scale, typically used on the VAS, although no visual will be used. Please see the supplemental script document attached to this protocol for the instructions used.
Part 3: Participants in the experimental group will participate in a six-week core stabilization intervention program. Please see the attached intervention program. This program will commence as soon as possible after Parts 1 and 2 of the investigation are completed. Participants will participate in two scheduled intervention sessions each week. Additionally, there will be a home exercise program, consisting of exercises from each week to be performed at home independently. Participants will be provided education and a handout on these exercises by the PI, which will include directions, photographs of the exercises, and a completion check-off for each session. These will be performed three times per week, every other day. The PI will be coordinator of the scheduling and performance of these interventions. These intervention sessions will be performed in the RFP Clinic in the SAHP, either in the open gym or in a private treatment room. This decision will be left up to the participant. More than one participant may or may not undergo intervention with the PI simultaneously, but only with the participants' consent. No more than three participants will undergo the training simultaneously. Training sessions will not be performed on consecutive days in an effort to reduce the chances of delayed onset muscle soreness being present during treatment sessions. Additionally, the core training program includes predetermined guidelines on exercise progressions in order to ensure that the exercises are not progressed too rapidly. The PI will be present and will lead all sessions, ensuring that the exercises and their progressions are done correctly.
After the completion of the intervention program, each participant will undergo gait analysis in the same manner mentioned in Part 1, with the exception of no anthropometric data being collected. Participants will then complete a second, post-intervention KOOS questionnaire, and turn in their home exercise program sheet with tallies from completed sessions. Please see Part 1 for completion of the pre-intervention KOOS questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baseline Gait Comparisons of Groups | No intervention | –Determine if kinetic (time to first peak ground reaction force [T1] and second peak ground reaction force [F2], both in the sagittal plane) and kinematic (peak stance knee flexion angle [KFA] and external knee adduction moment [KAM]) gait variables, and speed, differ between patients with KOA and age and gender matched controls during self-selected paced ambulation, and determine which ones have predictive relationships with Knee Injury and Osteoarthritis Outcome Score (KOOS) scores in the patients with KOA. |
| Gait with core activation | Experimental | Other: Core ActivationDetermine if volitional core activation alters gait kinetics (T1 and F2), kinematics (KFA and KAM), and speed in patients with and without KOA during self-selected paced ambulation when compared to ambulating without volitional core activation, and whether the subjective pain complaints are significantly changed in the group with KOA. Determine whether there are baseline differences in core activation between those with and without KOA. |
| Knee OA Gait After core stabilization | Experimental | Other: Core StabilizationDetermine if a six-week core stabilization program alters KOOS score, and the kinetics (T1 and F2), kinematics (KFA and KAM), and speed of gait in patients with KOA during self-selected paced ambulation as compared to their pre-intervention baselines. Determine if there is a predictive relationship between the number of completed intervention sessions performed and these observed changes. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- English-speaking men and women
- 40 years old and older
- any race or ethnic group
- a documented diagnosis from a medical provider (i.e., physician, physician assistant, or nurse practitioner, etc.) of KOA, unilaterally or bilaterally.
- Previous or current physical therapy patients may be included (see exclusion criteria for exceptions).
Key exclusion criteria (8 listed)
- Those with other lower extremity injuries (orthopaedic, cardiovascular, neurologic, etc.) which are currently hindering their ability to ambulate
- those with current complaints of low back pain
- those who have undergone bilateral total knee arthroplasty
- those with concomitant diagnosis of rheumatoid arthritis
- those persons not able to ambulate independently with or without an assistive device
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 |
|---|---|---|
| Core ActivationVolitional activation of the transversus abdominis muscle during self-selected paced ambulation for both groups. | Other | Gait with core activation |
| Core StabilizationSix-week core stabilization program for the group of participants with knee osteoarthritis. | Other | Knee OA Gait After core stabilization |
Primary outcome
Time to First Peak Ground Reaction Force in the Sagittal Plane (T1)
Time frame: Through study completion, on average about 1 year.
Kinetic variable observed during gait analysis.
Second Peak Ground Reaction Force in the Sagittal Plane (F2)
Time frame: Through study completion, on average about 1 year.
Kinetic variable observed during gait analysis.
Peak Stance Knee Flexion Angle (KFA)
Time frame: Through study completion, on average about 1 year.
Kinematic variable observed during gait analysis.
External Knee Adduction Moment (KAM)
Time frame: Through study completion, on average about 1 year.
Kinematic variable observed during gait analysis.
Gait Speed
Time frame: Through study completion, on average about 1 year.
Self-selected gait velocity of each participant during gait analysis.
3 secondary outcomes
Pain Rating on Visual Analog Scale (VAS)
Time frame: Through study completion, on average about 1 year.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Through study completion, on average about 1 year.
Transversus Abdominis Activation
Time frame: Through study completion, on average about 1 year.
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 25 Feb 2020.
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- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Daniel W Flowers, DPT principal investigator
Louisiana State University Health Sciences Center Shreveport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Activation and Core Stabilization in people with Osteoarthritis, Knee, run by Louisiana State University Health Sciences Center Shreveport 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 8 inclusion and 8 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 25 Feb 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?
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?
Time to First Peak Ground Reaction Force in the Sagittal Plane (T1) (time frame: Through study completion, on average about 1 year.). The study lists 5 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 NCT03776981, which also lists 29 linked publications.
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 25 Feb 2020.