Osteoarthritis, KneeNCT02543736
Reliability and Validity of Gait and Postural Balance Parameters
A study testing Instrumented Treadmill System in people with Osteoarthritis, Knee, run by Schulthess Klinik at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Instrumented Treadmill System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Instrumented Treadmill System
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrumented Treadmill SystemDevice
Also called Photoelectric Cell 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.
| Study group | Role | What they receive |
|---|---|---|
| Instrumented Treadmill System | Other | The Instrumented Treadmill System records vertical ground reaction force and pressures. Receives: Device: Instrumented Treadmill System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial gait Parameter: step length (cm)
Measured: baseline
Temporal gait Parameter: cadence (step/min)
Measured: baseline
Postural Balance Parameter: Centre of pressure path length (cm)
Measured: baseline
Postural Balance Parameter: Centre of pressure velocity (m/s)
Measured: baseline
Secondary outcomes (5)
Spatial gait Parameter: step width (cm)
Measured: baseline
Temporal gait Parameter: single limb support (% of gait cycle)
Measured: baseline
Kinetic gait Parameter: heel/toe force (N)
Measured: baseline
Postural Balance Parameter: Centre of pressure displacement in the medio-lateral and antero-posterior direction (mm)
Measured: baseline
Postural Balance Parameter: Centre of pressure area (mm2)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicola Casartelli, PhD, Principal investigator, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543736
- Sponsor's protocol ID
- Treadmill Study
- Status last verified
- Dec 2023
- First submitted
- 28 Aug 2015
- Last updated
- 22 Dec 2023
- Results posted
- No
Publications
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.
PubMed 16331521Elbaz 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.
PubMed 24418677Faude 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.
PubMed 22555061Hinman 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.
PubMed 12468818Lee 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.
PubMed 25017613Lee 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.
PubMed 24567681Lienhard 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.
PubMed 22818403Reed 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.
PubMed 23964707Sorensen 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.
PubMed 24480548Zeni 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.
PubMed 19285768Hassan 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.
PubMed 11350851Duffell 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.
PubMed 24582072Mills 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.
PubMed 23554153Turcot 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.
PubMed 21184837
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of Gait and Postural Balance Parameters Using an Instrumented Treadmill in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02543736
- Acronym / sponsor ID
- Treadmill Study
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Instrumented Treadmill System | Other | Device: Instrumented Treadmill SystemThe Instrumented Treadmill System records vertical ground reaction force and pressures. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instrumented Treadmill SystemAlso: Photoelectric Cell SystemPatients 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. | Device | Instrumented Treadmill System |
Primary outcome
Spatial gait Parameter: step length (cm)
Time frame: baseline
Temporal gait Parameter: cadence (step/min)
Time frame: baseline
Postural Balance Parameter: Centre of pressure path length (cm)
Time frame: baseline
Postural Balance Parameter: Centre of pressure velocity (m/s)
Time frame: baseline
5 secondary outcomes
Spatial gait Parameter: step width (cm)
Time frame: baseline
Temporal gait Parameter: single limb support (% of gait cycle)
Time frame: baseline
Kinetic gait Parameter: heel/toe force (N)
Time frame: baseline
Postural Balance Parameter: Centre of pressure displacement in the medio-lateral and antero-posterior direction (mm)
Time frame: baseline
Postural Balance Parameter: Centre of pressure area (mm2)
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Background: PubMed 16331521Bejek 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.
- Background: PubMed 24418677Elbaz 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.
- Background: PubMed 22555061Faude 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.
- Background: PubMed 12468818Hinman 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.
- Background: PubMed 25017613Lee 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.
- Background: PubMed 24567681Lee 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.
- Background: PubMed 22818403Lienhard 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.
- Background: PubMed 23964707Reed 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.
- Background: PubMed 24480548Sorensen 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.
- Background: PubMed 19285768Zeni 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.
- Background: PubMed 11350851Hassan 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.
- Background: PubMed 24582072Duffell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Casartelli, PhD principal investigator
Schulthess Klinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrumented Treadmill System in people with Osteoarthritis, Knee, run by Schulthess Klinik at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial gait Parameter: step length (cm) (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02543736, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023; AzTrials last refreshed its copy on 6 Nov 2026.