search
Back to results

Gait, Stair Climbing and Postural Stability in Knee Osteoarthritis Patients After Hyaluronic Acid Injection

Primary Purpose

Bilateral Knee Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Hyaluronic acid
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bilateral Knee Osteoarthritis

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Mild and moderate bilateral knee osteoarthritis
  • Age between 50 and 70 years

Exclusion Criteria:

  • Recent Lower limb injury
  • Diabetic
  • Knee or hip replacement
  • Knees HA injection in last 6 months
  • Any neuromuscular disease such as stroke and Parkinson

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    biomechanis knee OA and HA injection

    Arm Description

    Weekly intra- articular Hyaluronic acid injection (20 MG/ 2 ML) into both knees for five weeks

    Outcomes

    Primary Outcome Measures

    Change in Postural stability after treatment
    Changes in Biomechanics of gait after treatment
    Changes in biomechanics of stair climbing after treatment

    Secondary Outcome Measures

    Change in Pain after treatment
    Changes in WOMAC scores after treatment

    Full Information

    First Posted
    February 11, 2014
    Last Updated
    February 12, 2014
    Sponsor
    University of Malaya
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02063373
    Brief Title
    Gait, Stair Climbing and Postural Stability in Knee Osteoarthritis Patients After Hyaluronic Acid Injection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2012 (undefined)
    Primary Completion Date
    October 2013 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Malaya

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Treatment: five intro-articular Hyaluronic Acid injection Assessment has two parts, that are as follow: Postural stability and risk of fall assessment using Biodex stability index and "Timed up and Go" test Gait and stair climbing assessment using Vicon motion capture system synchronized with four force plates. For knee OA subjects, assessment was done in week one or before injection; and for healthy controls one assessment was performed.
    Detailed Description
    This study aimed to assess the effect of hyaluronic acid injection on Postural stability, biomechanics of gait and stair climbing in individuals with bilateral knee osteoarthritis (OA). Participants were individuals with knee OA (control and treatment) and healthy people.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bilateral Knee Osteoarthritis

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    85 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    biomechanis knee OA and HA injection
    Arm Type
    Experimental
    Arm Description
    Weekly intra- articular Hyaluronic acid injection (20 MG/ 2 ML) into both knees for five weeks
    Intervention Type
    Other
    Intervention Name(s)
    Hyaluronic acid
    Other Intervention Name(s)
    Hyalgan, Manufacturer: Fidia Pharmaceutici S.p.A, Italy
    Intervention Description
    treatment: Weekly intra-articular hyaluronic acid injection (20 MG / 2ML) into both knees for five weeks.
    Primary Outcome Measure Information:
    Title
    Change in Postural stability after treatment
    Time Frame
    baseline and 6 weeks
    Title
    Changes in Biomechanics of gait after treatment
    Time Frame
    baseline and 6 weeks
    Title
    Changes in biomechanics of stair climbing after treatment
    Time Frame
    baseline and 6 weeks
    Secondary Outcome Measure Information:
    Title
    Change in Pain after treatment
    Time Frame
    baseline and 6 weeks
    Title
    Changes in WOMAC scores after treatment
    Time Frame
    baseline and 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Mild and moderate bilateral knee osteoarthritis Age between 50 and 70 years Exclusion Criteria: Recent Lower limb injury Diabetic Knee or hip replacement Knees HA injection in last 6 months Any neuromuscular disease such as stroke and Parkinson

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25136689
    Citation
    Khalaj N, Abu Osman NA, Mokhtar AH, George J, Abas WA. Effect of intra-articular hyaluronic injection on postural stability and risk of fall in patients with bilateral knee osteoarthritis. ScientificWorldJournal. 2014;2014:815184. doi: 10.1155/2014/815184. Epub 2014 Jun 19.
    Results Reference
    derived

    Learn more about this trial

    Gait, Stair Climbing and Postural Stability in Knee Osteoarthritis Patients After Hyaluronic Acid Injection

    We'll reach out to this number within 24 hrs