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Osteoarthritis, KneeNCT03513094

Effect of TA Contraction on Gait in Patients With Knee OA

A study testing Transversus Abdominis Contraction in people with Osteoarthritis, Knee, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to study the effects of core activation on knee joint loading during ambulation in patients with knee osteoarthritis (OA). This study aims to investigate the effects of transversus abdominis (TA) activation during simultaneous kinetic analysis of time to initial peak ground reaction force… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Transversus Abdominis Contraction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
4 Aug 2017to 29 Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • those with medical diagnosis (providing written evidence from a physician, physician assistant, or nurse practitioner) of knee OA unilaterally or bilaterally.

Who cannot join

  • bilateral total knee arthroplasty, requirement of an assistive device or assistance with ambulation, spinal diagnoses which contraindicate participation in spinal stabilization activities, and those currently limited by another lower extremity pathology at the time of participation.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Louisiana State University Health Sciences Center - Shreveport

    Shreveport, Louisiana, 71130

Other trials in United States

About this study

Official title: The Effect of Volitional Transversus Abdominis Contraction on Time to Peak Sagittal Ground Reaction Force in Patients With Knee Osteoarthritis

The purpose of this study is to study the effects of core activation on knee joint loading during ambulation in patients with knee osteoarthritis (OA). This study aims to investigate the effects of transversus abdominis (TA) activation during simultaneous kinetic analysis of time to initial peak ground reaction force (T1) at the heel in the sagittal plane.

The objective of this study is to determine whether patients with knee OA demonstrate changes in T1 during comfortable gait speeds when actively contracting the TA muscle. In addition, this study will serve as a pilot study in order to perform a post-hoc power analysis for future study on the effects of the independent variable (TA contraction/changes in core stability) on the dependent variable (T1).

Read more

Null hypothesis: There will be no change in T1 in patients with knee OA during gait while contracting their TA.

Alternate hypothesis: There will be a decrease in T1 in patients with knee OA during gait while contracting their TA.

Read the detailed description

This will be the first study on this topic performed by the investigator. Regarding current knowledge gaps, evidence has shown an influence of core strength measures/stability on lower extremity function. This relationship has been examined very little in patients with knee OA; however, evidence does show a correlation exists. There have been no studies examining the effect of a core strengthening/stability intervention on lower extremity kinetics in patients with knee OA to the PIs knowledge.

This is the first study examining the effects of TA contraction knee loading during gait in this population.

Current evidence shows that core activation/stability may play a role in lower extremity kinetics and kinematics. Most research has focused on younger, more athletic individuals. Research on this population has in the past looked at patellofemoral disorders or ligamentous injury. For example, decreased core function has been shown to increase the risk of sustaining anterior cruciate ligament injury. In addition, increased core stability has resulted in decreased knee loading during athletic activities.

There continues to be an overall paucity of research on proper prescription and dosage of therapeutic exercise for patients with knee OA. Evidence has shown that quadriceps strengthening and aerobic conditioning do lead to decreased disability. Additionally, patients with knee osteoarthritis have decreased postural stability as compared to healthy controls, with a significant correlation being observed between their score on a postural stability measure and the Western Ontario and McMaster Universities Osteoarthritis Index. Patients with knee OA also exhibit decreased overall core stability as compared to healthy controls. This body of research however does not include any evidence on the effects of a core stability intervention on improving overall function.

Knee OA leads to abnormalities in kinetic loading of the lower extremity during ambulation. An increase in T1 in this population has been observed when comparing to healthy controls. Separately, studies have shown that in patients with knee OA, knee joint loading can be influenced by intraarticular hyaluronic acid injections, resulting in decreased T1. Therefore, this study will explore the idea of how activation of a muscle (TA), which plays a large role in core stability, influences kinetic loading (T1) during ambulation in patients with knee OA.

Each participant will only be required to participate for one session, lasting about 1 hour. This does not included the informed consent process requiring approximately 30 minutes of their time prior to participation. Approximately 5 months will be required to enroll all participants. It is the PI's goal to complete primary data analysis no more than 3 months after data collection is complete, so total estimated study time is 8 months.

The primary study endpoint will be the cessation of data collection and the participants' active participation in the research program. The Secondary endpoint will be the completion of data analysis, which concludes the management of PHI.

Primary (exposure to any physical risk) and secondary (management of PHI) safety endpoints are synonymous with the study endpoints mentioned in 8.1.

This project serves as pilot study for future investigation on the role of core stabilization on gait kinetics in patients with knee OA. Therefore the sample size will be small. Post-hoc power analysis will inform the PI about requirements for participant recruitment needs for future investigations.

After informed consent is completed, participants will be scheduled for a session in the Motion Analysis Laboratory in the SAHP. Patients will have already been asked to wear close fitting, exercise appropriate clothing to allow marker placement, and prevent marker blocking during motion analysis. Data collection will begin by collecting the following anthropometric data: body weight (pounds, converted to kilograms) via a scale, height (inches, converted to mm) via a tape measure, leg length from ipsilateral anterior superior iliac spine to ipsilateral medial malleolus bilaterally (cm) via tape measure, and knee and ankle joint widths (cm) via a caliper. After collection of this data is completed and recorded, the PI will place reflective markers on the patient's skin via adhesive tape made for this purpose at the following landmarks bilaterally: ASIS, posterior superior iliac spine, lateral thigh, knee center of rotation, lateral leg, heel, lateral malleolus, and base of the second metatarsal. When this set-up is complete, static calibration of the motion analysis system will take place with the participant standing still in the capture area. When this is complete, the participant will be allowed a 2-minute warm-up by walking back and forth in the capture area. When this is completed the participant will be asked to walk at a comfortable pace across the capture area. Three trials with good force plate contact will be collected. After these three trials are obtained, the patient will lie supine on the mat in the lab, and will be taught how to perform a TA contraction. A Pathway MR-20 biofeedback device (The Prometheus Group, Dover, NH, USA) with two electrodes will be placed just medial to the ASISs on the participant's abdomen. 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 at 50% MVIC. The task will be repeated seated, standing, then ambulating three practice trials on the capture area. The participant will then be instructed to perform an additional three comfortable paced ambulation trials with good force plate contact while contracting the TA enough to cause audible feedback via the biofeedback device. After completing these three trials, the biofeedback device and reflective markers will be removed, and the participant will have completed their active participation in the study.

Being tested
Transversus Abdominis Contraction
Keywords
Kinetics, Transversus abdominis
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transversus Abdominis ContractionOther

    Participants were educated on how to contract their transversus abdominis (TA) muscle after having a surface EMG biofeedback device placed on their abdomen to provide audible biofeedback. Participants were asked to ambulate while maintaining TA contraction while ambulating at 50% of maximal volitional isometric contraction.

Study groups in NCT03513094
Study groupRoleWhat they receive
Without and With Transversus AbdominisExperimentalWithout: Participants performed three trials of self-selected, comfortable paced walking in the motion lab to collect kinetic data, without transversus abdominis contraction. With: Participants performed three trials of self-selected, comfortable paced walking in the motion lab to collect kinetic data, with 50% MVIC transversus abdominis contraction.
Receives: Other: Transversus Abdominis Contraction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kinetic Variable

    Time to first peak ground reaction force in the sagittal plane

    Measured: During walking trials

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2018
  2. Study start4 Aug 2017
  3. Primary completion29 Sep 2017
  4. Study completion29 Sep 2017

Resources

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
Not applicable
Intervention model
Single group
Model description
Single group, repeated measures.
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03513094
Sponsor's protocol ID
768
Status last verified
Apr 2018
First submitted
19 Apr 2018
Last updated
1 May 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Whyte 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 28605148
  • Messier SP, Loeser RF, Hoover JL, Semble EL, Wise CM. Osteoarthritis of the knee: effects on gait, strength, and flexibility. Arch Phys Med Rehabil. 1992 Jan;73(1):29-36.

    PubMed 1729969
  • Willson JD, Dougherty CP, Ireland ML, Davis IM. Core stability and its relationship to lower extremity function and injury. J Am Acad Orthop Surg. 2005 Sep;13(5):316-25. doi: 10.5435/00124635-200509000-00005.

    PubMed 16148357
  • Kibler WB, Press J, Sciascia A. The role of core stability in athletic function. Sports Med. 2006;36(3):189-98. doi: 10.2165/00007256-200636030-00001.

    PubMed 16526831
  • De Blaiser C, Roosen P, Willems T, Danneels L, Bossche LV, De Ridder R. Is core stability a risk factor for lower extremity injuries in an athletic population? A systematic review. Phys Ther Sport. 2018 Mar;30:48-56. doi: 10.1016/j.ptsp.2017.08.076. Epub 2017 Aug 24.

    PubMed 29246794
  • Shirey 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 22319676
  • Ferber 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 25365133
  • Tang SF, Chen CP, Chen MJ, Pei YC, Lau YC, Leong CP. Changes in sagittal ground reaction forces after intra-articular hyaluronate injections for knee osteoarthritis. Arch Phys Med Rehabil. 2004 Jun;85(6):951-5. doi: 10.1016/j.apmr.2003.08.095.

    PubMed 15179649
  • Hsieh RL, Lee WC, Lo MT, Liao WC. Postural stability in patients with knee osteoarthritis: comparison with controls and evaluation of relationships between postural stability scores and International Classification of Functioning, Disability and Health components. Arch Phys Med Rehabil. 2013 Feb;94(2):340-6. doi: 10.1016/j.apmr.2012.09.022. Epub 2012 Oct 4.

    PubMed 23041145
  • Iversen MD. Managing Hip and Knee Osteoarthritis with Exercise: What is the Best Prescription? Ther Adv Musculoskelet Dis. 2010 Oct;2(5):279-90. doi: 10.1177/1759720X10378374.

    PubMed 22870454
  • Chen CP, Chen MJ, Pei YC, Lew HL, Wong PY, Tang SF. Sagittal plane loading response during gait in different age groups and in people with knee osteoarthritis. Am J Phys Med Rehabil. 2003 Apr;82(4):307-12. doi: 10.1097/01.PHM.0000056987.33630.56.

    PubMed 12649658
  • Roddy E, Zhang W, Doherty M. Aerobic walking or strengthening exercise for osteoarthritis of the knee? A systematic review. Ann Rheum Dis. 2005 Apr;64(4):544-8. doi: 10.1136/ard.2004.028746.

    PubMed 15769914
  • Daud DMBA, Razak NRA, Lasimbang H. CORE STABILITY DEFICITS IN FEMALE KNEE OSTEOARTHRITIS PATIENTS. Academic Journal of Science. 4(3):117-124, 2015.

  • Dabholkar TA. Correlation of the core stability measures with the hip strength and functional activity level in knee osteoarthritis. International Journal of Therapies and Rehabilitation Research. 5(5):37-43, 2016.

Questions about this trial

What is this clinical trial studying?

A study testing Transversus Abdominis Contraction 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 1 inclusion and 1 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 1 May 2018. 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?

Kinetic Variable (time frame: During walking trials). 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 NCT03513094, which also lists 14 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 1 May 2018.

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