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

February 12, 2014 updated by: nafiseh khalaj, University of Malaya

Treatment: five intro-articular Hyaluronic Acid injection

Assessment has two parts, that are as follow:

  1. Postural stability and risk of fall assessment using Biodex stability index and "Timed up and Go" test
  2. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

85

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: biomechanis knee OA and HA injection
Weekly intra- articular Hyaluronic acid injection (20 MG/ 2 ML) into both knees for five weeks
Other: Hyaluronic acid
treatment: Weekly intra-articular hyaluronic acid injection (20 MG / 2ML) into both knees for five weeks.
Other Names:
  • Hyalgan
  • Manufacturer: Fidia Pharmaceutici S.p.A, Italy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Postural stability after treatment
Time Frame: baseline and 6 weeks
baseline and 6 weeks
Changes in Biomechanics of gait after treatment
Time Frame: baseline and 6 weeks
baseline and 6 weeks
Changes in biomechanics of stair climbing after treatment
Time Frame: baseline and 6 weeks
baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Pain after treatment
Time Frame: baseline and 6 weeks
baseline and 6 weeks
Changes in WOMAC scores after treatment
Time Frame: baseline and 6 weeks
baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

February 11, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (ESTIMATE)

February 14, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2014

Last Update Submitted That Met QC Criteria

February 12, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UM/MOHE/HIR D000010-16001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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