NCT03513094

Brief 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 (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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 4, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 1, 2018

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

2 months

First QC Date

April 19, 2018

Last Update Submit

April 30, 2018

Conditions

Keywords

KineticsTransversus abdominis

Outcome Measures

Primary Outcomes (1)

  • Kinetic Variable

    Time to first peak ground reaction force in the sagittal plane

    During walking trials

Study Arms (1)

Without and With Transversus Abdominis

EXPERIMENTAL

Without: 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.

Other: Transversus Abdominis Contraction

Interventions

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.

Without and With Transversus Abdominis

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130, United States

Location

Related Publications (14)

  • 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.

    PMID: 28605148BACKGROUND
  • 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.

    PMID: 1729969BACKGROUND
  • 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.

    PMID: 16148357BACKGROUND
  • 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.

    PMID: 16526831BACKGROUND
  • 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.

    PMID: 29246794BACKGROUND
  • 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.

    PMID: 22319676BACKGROUND
  • 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.

    PMID: 25365133BACKGROUND
  • 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.

    PMID: 15179649BACKGROUND
  • 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.

    PMID: 23041145BACKGROUND
  • 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.

    PMID: 22870454BACKGROUND
  • 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.

    PMID: 12649658BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Daniel W Flowers, DPT

    LSUHSC-Shreveport

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single group, repeated measures.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor of Physical Therapy

Study Record Dates

First Submitted

April 19, 2018

First Posted

May 1, 2018

Study Start

August 4, 2017

Primary Completion

September 29, 2017

Study Completion

September 29, 2017

Last Updated

May 1, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations