Core Activation and Stabilization for Knee OA

NCT03776981 | Completed

• 2 other identifiers: STUDY00001065Study #20344
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (5)

• Time to First Peak Ground Reaction Force in the Sagittal Plane (T1)

  Kinetic variable observed during gait analysis.

  Through study completion, on average about 1 year.

• Second Peak Ground Reaction Force in the Sagittal Plane (F2)

  Kinetic variable observed during gait analysis.

  Through study completion, on average about 1 year.

• Peak Stance Knee Flexion Angle (KFA)

  Kinematic variable observed during gait analysis.

  Through study completion, on average about 1 year.

• External Knee Adduction Moment (KAM)

  Kinematic variable observed during gait analysis.

  Through study completion, on average about 1 year.

• Gait Speed

  Self-selected gait velocity of each participant during gait analysis.

  Through study completion, on average about 1 year.

Secondary Outcomes (3)

• Pain Rating on Visual Analog Scale (VAS)

  Through study completion, on average about 1 year.

• Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Through study completion, on average about 1 year.

• Transversus Abdominis Activation

  Through study completion, on average about 1 year.

Study Arms (3)

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.

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.

Other: Core Stabilization

Interventions

Core Activation OTHER

Volitional activation of the transversus abdominis muscle during self-selected paced ambulation for both groups.

Gait with core activation

Core Stabilization OTHER

Six-week core stabilization program for the group of participants with knee osteoarthritis.

Knee OA Gait After core stabilization

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking men and women
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Louisiana State University Health Sciences Center Shreveport: lead
• Texas Woman's University: collaborator

Study Sites (1)

Louisiana State University Health Sciences Center - Shreveport

Shreveport, Louisiana, 71130, United States

Location

Related Publications (29)

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  PMID: 33421757 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Daniel W Flowers, DPT

  Louisiana State University Health Sciences Center Shreveport

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 17, 2018
• Study Start: January 8, 2019
• Primary Completion: December 11, 2019
• Study Completion: December 11, 2019
• Last Updated: February 25, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)