Reliability and Validity of Gait and Postural Balance Parameters

December 18, 2023 updated by: Schulthess Klinik

Reliability and Validity of Gait and Postural Balance Parameters Using an Instrumented Treadmill in Patients With Knee Osteoarthritis

Knee osteoarthritis (KOA) patients, have impairments in gait and balance. Accurate gait and postural balance analysis is needed to detect this impairments. Nevertheless methodological quality about the recording of gait and balance analysis in KOA patients is lacking in literature.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In patients with knee osteoarthritis (KOA), impairments in gait and balance are well recognized and therefore objective and accurate gait and postural balance analysis is crucial to detect potential alterations in balance and gait function in this patient group.

Gait analysis in orthopaedic patients has been mainly investigated during level walking at a self-selected speed or at pre-determined gait velocities. Nevertheless, walking at a comfortable speed may not necessary result in any gait impairments and therefore the use of more challenging tasks is probably required. In addition, some patients are not able to walk at a required walking speed or slope, because of pain and disability. Therefore it seems reasonable to evaluate gait parameters of KOA patients while walking at different speeds and surface inclinations.

Postural balance parameters are also important outcome measures in the assessment of KOA patients. Postural stability is generally assessed throughout the quantification of the displacement and velocity of the centre of pressure (COP) with larger excursions and higher velocities indicating poorer balance.

Recently, instrumented treadmill systems (ITS) have been introduced for the evaluation of spatiotemporal and kinetic gait as well as postural balance parameters throughout a capacitance-based foot pressure platform. Further, they permit an assessment of the gait parameters at different speeds and slopes. Spatiotemporal and kinetic gait parameters provided by ITS have been shown to be valid and reliable during level walking in healthy young and elderly persons and during walking at different speeds and slopes. ITS can also be used for the quantification of static balance, because they are able to provide the velocity and displacement changes of COP. However the validity and reliability of gait and postural balance analysis at different slopes and speeds in patients with KOA are lacking.

Similarly to ITS, photoelectric cell systems (PCS) also permit the quantification of spatiotemporal gait parameters but in addition they are portable, their set up is very quick, they are relatively cheap and can be adapted to a treadmill. PCS have been shown to be both valid and reliable for the assessment of spatiotemporal gait parameters in healthy adults and also in KOA patients.

The main aim of this study is to evaluate the methodological quality of postural and gait parameters assessed at different treadmill inclinations and velocities using an ITS in patients with KOA. In particular, we will investigate the test-retests reliability, the discriminant validity and the concurrent validity.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Daniela Pacifico, BSc in PT
  • Phone Number: +41 (0)44 385 70 46
  • Email: pada@kws.ch

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8008
        • Schulthess Klinik

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

45 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 45 to 85 years.
  • Men and women.
  • Unilateral symptomatic KOA.
  • Patient in waitlist at the Schulthess Clinic for knee arthroplasty.
  • Living place: Canton of Zurich or neighbouring Cantons.
  • Signed written informed consent.

Exclusion Criteria:

  • Symptomatic OA in lower extremity joints other than the knee.
  • Bilateral symptomatic KOA.
  • Usage of walking aids.
  • Surgery to the lower limbs in the prior 12 months.
  • BMI >35 kg/m2.
  • Disorders that affect gait or balance function.

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: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Instrumented Treadmill System
The Instrumented Treadmill System records vertical ground reaction force and pressures.
Device: Instrumented Treadmill System
Patients will perform twice a gait and a balance analysis on an instrumented treadmill system combined to a photoelectric cell system while controls will only perform once.
Other Names:
  • Photoelectric Cell System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Spatial gait Parameter: step length (cm)
Time Frame: baseline
baseline
Temporal gait Parameter: cadence (step/min)
Time Frame: baseline
baseline
Postural Balance Parameter: Centre of pressure path length (cm)
Time Frame: baseline
baseline
Postural Balance Parameter: Centre of pressure velocity (m/s)
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Spatial gait Parameter: step width (cm)
Time Frame: baseline
baseline
Temporal gait Parameter: single limb support (% of gait cycle)
Time Frame: baseline
baseline
Kinetic gait Parameter: heel/toe force (N)
Time Frame: baseline
baseline
Postural Balance Parameter: Centre of pressure displacement in the medio-lateral and antero-posterior direction (mm)
Time Frame: baseline
baseline
Postural Balance Parameter: Centre of pressure area (mm2)
Time Frame: baseline
baseline

Collaborators and Investigators

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

Sponsor

Schulthess Klinik

Investigators

  • Principal Investigator: Nicola Casartelli, PhD, Schulthess Klinik

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

July 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

August 28, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimated)

September 7, 2015

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Treadmill Study

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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