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Reliability and Validity of Gait and Postural Balance Parameters

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Instrumented Treadmill System
Sponsored by
Schulthess Klinik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Osteoarthritis, Knee

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Schulthess KlinikRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Instrumented Treadmill System

Arm Description

The Instrumented Treadmill System records vertical ground reaction force and pressures.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 28, 2015
Last Updated
September 4, 2015
Sponsor
Schulthess Klinik
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1. Study Identification

Unique Protocol Identification Number
NCT02543736
Brief Title
Reliability and Validity of Gait and Postural Balance Parameters
Official Title
Reliability and Validity of Gait and Postural Balance Parameters Using an Instrumented Treadmill in Patients With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Schulthess Klinik

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Instrumented Treadmill System
Arm Type
Other
Arm Description
The Instrumented Treadmill System records vertical ground reaction force and pressures.
Intervention Type
Device
Intervention Name(s)
Instrumented Treadmill System
Other Intervention Name(s)
Photoelectric Cell System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spatial gait Parameter: step length (cm)
Time Frame
baseline
Title
Temporal gait Parameter: cadence (step/min)
Time Frame
baseline
Title
Postural Balance Parameter: Centre of pressure path length (cm)
Time Frame
baseline
Title
Postural Balance Parameter: Centre of pressure velocity (m/s)
Time Frame
baseline
Secondary Outcome Measure Information:
Title
Spatial gait Parameter: step width (cm)
Time Frame
baseline
Title
Temporal gait Parameter: single limb support (% of gait cycle)
Time Frame
baseline
Title
Kinetic gait Parameter: heel/toe force (N)
Time Frame
baseline
Title
Postural Balance Parameter: Centre of pressure displacement in the medio-lateral and antero-posterior direction (mm)
Time Frame
baseline
Title
Postural Balance Parameter: Centre of pressure area (mm2)
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Pacifico, BSc in PT
Phone
+41 (0)44 385 70 46
Email
pada@kws.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Casartelli, PhD
Organizational Affiliation
Schulthess Klinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schulthess Klinik
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Pacifico, BSc PT
Phone
+41 (0)44 385 70 46
Email
pada@kws.ch

12. IPD Sharing Statement

Citations:
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16331521
Citation
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Citation
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Results Reference
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PubMed Identifier
12468818
Citation
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Citation
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Results Reference
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PubMed Identifier
24567681
Citation
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Results Reference
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Citation
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Citation
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Citation
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Citation
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Reliability and Validity of Gait and Postural Balance Parameters

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