Reliability and Validity of Gait and Postural Balance Parameters

NCT02543736 | Completed

• 1 other identifier: Treadmill Study
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (4)

• Spatial gait Parameter: step length (cm)

  baseline

• Temporal gait Parameter: cadence (step/min)

  baseline

• Postural Balance Parameter: Centre of pressure path length (cm)

  baseline

• Postural Balance Parameter: Centre of pressure velocity (m/s)

  baseline

Secondary Outcomes (5)

• Spatial gait Parameter: step width (cm)

  baseline

• Temporal gait Parameter: single limb support (% of gait cycle)

  baseline

• Kinetic gait Parameter: heel/toe force (N)

  baseline

• Postural Balance Parameter: Centre of pressure displacement in the medio-lateral and antero-posterior direction (mm)

  baseline

• Postural Balance Parameter: Centre of pressure area (mm2)

  baseline

Study Arms (1)

Instrumented Treadmill System

OTHER

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

Device: Instrumented Treadmill System

Interventions

Instrumented Treadmill System DEVICE

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.

Also known as: Photoelectric Cell System

Instrumented Treadmill System

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Schulthess Klinik: lead

Study Sites (1)

Schulthess Klinik

Zurich, 8008, Switzerland

Location

Related Publications (14)

• Bejek Z, Paroczai R, Illyes A, Kiss RM. The influence of walking speed on gait parameters in healthy people and in patients with osteoarthritis. Knee Surg Sports Traumatol Arthrosc. 2006 Jul;14(7):612-22. doi: 10.1007/s00167-005-0005-6. Epub 2005 Dec 6.

  PMID: 16331521 BACKGROUND

• Elbaz A, Mor A, Segal G, Debi R, Shazar N, Herman A. Novel classification of knee osteoarthritis severity based on spatiotemporal gait analysis. Osteoarthritis Cartilage. 2014 Mar;22(3):457-63. doi: 10.1016/j.joca.2013.12.015. Epub 2014 Jan 10.

  PMID: 24418677 BACKGROUND

• Faude O, Donath L, Roth R, Fricker L, Zahner L. Reliability of gait parameters during treadmill walking in community-dwelling healthy seniors. Gait Posture. 2012 Jul;36(3):444-8. doi: 10.1016/j.gaitpost.2012.04.003. Epub 2012 May 1.

  PMID: 22555061 BACKGROUND

• Hinman RS, Bennell KL, Metcalf BR, Crossley KM. Balance impairments in individuals with symptomatic knee osteoarthritis: a comparison with matched controls using clinical tests. Rheumatology (Oxford). 2002 Dec;41(12):1388-94. doi: 10.1093/rheumatology/41.12.1388.

  PMID: 12468818 BACKGROUND

• Lee M, Song C, Lee K, Shin D, Shin S. Agreement between the spatio-temporal gait parameters from treadmill-based photoelectric cell and the instrumented treadmill system in healthy young adults and stroke patients. Med Sci Monit. 2014 Jul 14;20:1210-9. doi: 10.12659/MSM.890658.

  PMID: 25017613 BACKGROUND

• Lee MM, Song CH, Lee KJ, Jung SW, Shin DC, Shin SH. Concurrent Validity and Test-retest Reliability of the OPTOGait Photoelectric Cell System for the Assessment of Spatio-temporal Parameters of the Gait of Young Adults. J Phys Ther Sci. 2014 Jan;26(1):81-5. doi: 10.1589/jpts.26.81. Epub 2014 Feb 6.

  PMID: 24567681 BACKGROUND

• Lienhard K, Schneider D, Maffiuletti NA. Validity of the Optogait photoelectric system for the assessment of spatiotemporal gait parameters. Med Eng Phys. 2013 Apr;35(4):500-4. doi: 10.1016/j.medengphy.2012.06.015. Epub 2012 Jul 18.

  PMID: 22818403 BACKGROUND

• Reed LF, Urry SR, Wearing SC. Reliability of spatiotemporal and kinetic gait parameters determined by a new instrumented treadmill system. BMC Musculoskelet Disord. 2013 Aug 21;14:249. doi: 10.1186/1471-2474-14-249.

  PMID: 23964707 BACKGROUND

• Sorensen RR, Jorgensen MG, Rasmussen S, Skou ST. Impaired postural balance in the morning in patients with knee osteoarthritis. Gait Posture. 2014 Apr;39(4):1040-4. doi: 10.1016/j.gaitpost.2014.01.002. Epub 2014 Jan 8.

  PMID: 24480548 BACKGROUND

• Zeni JA Jr, Higginson JS. Differences in gait parameters between healthy subjects and persons with moderate and severe knee osteoarthritis: a result of altered walking speed? Clin Biomech (Bristol). 2009 May;24(4):372-8. doi: 10.1016/j.clinbiomech.2009.02.001. Epub 2009 Mar 13.

  PMID: 19285768 BACKGROUND

• Hassan BS, Mockett S, Doherty M. Static postural sway, proprioception, and maximal voluntary quadriceps contraction in patients with knee osteoarthritis and normal control subjects. Ann Rheum Dis. 2001 Jun;60(6):612-8. doi: 10.1136/ard.60.6.612.

  PMID: 11350851 BACKGROUND

• Duffell LD, Southgate DF, Gulati V, McGregor AH. Balance and gait adaptations in patients with early knee osteoarthritis. Gait Posture. 2014 Apr;39(4):1057-61. doi: 10.1016/j.gaitpost.2014.01.005. Epub 2014 Jan 19.

  PMID: 24582072 BACKGROUND

• Mills K, Hunt MA, Ferber R. Biomechanical deviations during level walking associated with knee osteoarthritis: a systematic review and meta-analysis. Arthritis Care Res (Hoboken). 2013 Oct;65(10):1643-65. doi: 10.1002/acr.22015.

  PMID: 23554153 BACKGROUND

• Turcot K, Hagemeister N, de Guise JA, Aissaoui R. Evaluation of unipodal stance in knee osteoarthritis patients using knee accelerations and center of pressure. Osteoarthritis Cartilage. 2011 Mar;19(3):281-6. doi: 10.1016/j.joca.2010.12.007. Epub 2010 Dec 22.

  PMID: 21184837 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Nicola Casartelli, PhD

  Schulthess Klinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 7, 2015
• Study Start: July 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 22, 2023

Record last verified: 2023-12

Locations

CH (1)