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Ankle OsteoarthritisAsymmetryNCT02489188

Gait Asymmetry Assessed Using Portable Gait Analysis System

An observational study of Ankle Osteoarthritis and Knee Osteoarthritis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To date, detailed analysis of movement patterns in orthopaedic conditions are mainly performed in research projects. Because these tests are time consuming, they are not feasible in clinical routine or in standard examinations. Novel technologies allow capturing detailed movement patters within a few minutes. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
arthroplasty, manual therapy and lumbar spinal stenosis decompression
Type of treatment
Surgery or procedure
How many people
150 participants
Where
1 siteSwitzerland
Study dates
Jun 2015to 30 Sep 2019
Phase
Observational
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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Subjects will be recruited from patients visiting the outpatient clinic or are scheduled for arthroplasty or LSS decompression at the University Hospital Basel and from the surrounding community.

Who may be able to join

  • Age ≥ 40 years, for patients: diagnosed osteoarthritis at the ankle, knee or hip, lumbar spinal stenosis or limited range of motion at the knee

Who cannot join

  • Body mass index > 35kg/m2
  • Use of walking aids
  • Inability to walk for 6 minutes
  • Neuromuscular disorders affecting gait
  • Cardiovascular disease
  • Inability to follow procedures due to psychological disorders or dementia

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital Basel

    Basel, Canton of Basel-City, 4031

Other trials in Switzerland

About this study

Official title: Gait Asymmetry in Orthopaedic Conditions of the Lower Extremity Assessed Using Portable and Laboratory Based Systems: Cross-sectional Observational Single-centre Pilot Study

To date, detailed analysis of movement patterns in orthopaedic conditions are mainly performed in research projects. Because these tests are time consuming, they are not feasible in clinical routine or in standard examinations. Novel technologies allow capturing detailed movement patters within a few minutes. The aim of this regional study is to compare aspects of movement tasks measured using a mobile gait analysis system to those measured using laboratory based systems and to determine aspects of gait patterns relevant for different orthopaedic conditions. Moreover, the researchers will investigate if these relevant aspects can be altered using surgical treatment or manual therapy.

Read the detailed description

This is a cross-sectional study. Pre- and post-treatment data will only be collected in patients undergoing routine orthopaedic treatment.

Being tested
arthroplasty, manual therapy, lumbar spinal stenosis decompression
Keywords
gait asymmetry, joint angles
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Hip, Contracture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • arthroplastyProcedure or surgery

    patients, who are scheduled for arthroplasty, will be measured before and on average 6 months after surgery

  • manual therapyOther

    patients, who are scheduled for manual therapy, will be measured before, immediately and on average 1 week after treatment

  • lumbar spinal stenosis decompressionProcedure or surgery

    patients, who are scheduled for lumbar spinal stenosis decompression, will be measured before and on average 6 months after surgery

Study groups in NCT02489188
Study groupRoleWhat they receive
ankle osteoarthritispatients with ankle osteoarthritis scheduled for arthroplasty
Receives: Procedure: arthroplasty; Other: manual therapy
knee osteoarthritispatients with knee osteoarthritis scheduled for arthroplasty
Receives: Procedure: arthroplasty; Other: manual therapy
hip osteoarthritispatients with hip osteoarthritis scheduled for arthroplasty
Receives: Procedure: arthroplasty; Other: manual therapy
lumbar spinal stenosispatients with lumbar spinal stenosis scheduled for lumbar spinal stenosis decompression
Receives: Other: manual therapy; Procedure: lumbar spinal stenosis decompression
muscle contracturepatients with functionally limited range of motion at the knee because of muscle contracture scheduled for manual therapy
Receives: Other: manual therapy
healthy subjectshealthy subjects

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. symmetry index

    gait asymmetry assessed using a portable and laboratory gait analysis systems

    Measured: up to 6 months

Secondary outcomes (4)

  1. change in symmetry index

    changes in gait asymmetry assessed using a portable and laboratory gait analysis systems

    Measured: up to 6 months

  2. maximum isokinetic joint moment [Nm]

    isokinetic muscle strength

    Measured: up to 6 months

  3. relative electromyographic (EMG) intensity

    electromyographic activity normalised to activity during maximum voluntary contraction

    Measured: up to 6 months

  4. differences between maximum flexion and extension [degrees]

    passive range of motion

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2015 (estimated)
  2. Study startJun 2015
  3. Primary completion30 Sep 2019
  4. Study completion30 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02489188
Sponsor's protocol ID
2015-139
Acronym
Asymmetry
Status last verified
Nov 2019
First submitted
23 Jun 2015
Last updated
15 Nov 2019
Results posted
No
Data monitoring committee
No

Publications

  • Horstmann T, Listringhaus R, Haase GB, Grau S, Mundermann A. Changes in gait patterns and muscle activity following total hip arthroplasty: a six-month follow-up. Clin Biomech (Bristol). 2013 Aug;28(7):762-9. doi: 10.1016/j.clinbiomech.2013.07.001. Epub 2013 Jul 29.

    PubMed 23906936

  • Horstmann T, Listringhaus R, Brauner T, Grau S, Mundermann A. Minimizing preoperative and postoperative limping in patients after total hip arthroplasty: relevance of hip muscle strength and endurance. Am J Phys Med Rehabil. 2013 Dec;92(12):1060-9. doi: 10.1097/PHM.0b013e3182970fc4.

    PubMed 23739275

  • Horstmann T, Vornholt-Koch S, Brauner T, Grau S, Mundermann A. Impact of total hip arthroplasty on pain, walking ability, and cardiovascular fitness. J Orthop Res. 2012 Dec;30(12):2025-30. doi: 10.1002/jor.22163. Epub 2012 May 31.

    PubMed 22653634

  • Mundermann A, Mundermann L, Andriacchi TP. Amplitude and phasing of trunk motion is critical for the efficacy of gait training aimed at reducing ambulatory loads at the knee. J Biomech Eng. 2012 Jan;134(1):011010. doi: 10.1115/1.4005540.

    PubMed 22482665

  • Mundermann A, Asay JL, Mundermann L, Andriacchi TP. Implications of increased medio-lateral trunk sway for ambulatory mechanics. J Biomech. 2008;41(1):165-70. doi: 10.1016/j.jbiomech.2007.07.001. Epub 2007 Aug 3.

    PubMed 17678933

  • Fisher DS, Dyrby CO, Mundermann A, Morag E, Andriacchi TP. In healthy subjects without knee osteoarthritis, the peak knee adduction moment influences the acute effect of shoe interventions designed to reduce medial compartment knee load. J Orthop Res. 2007 Apr;25(4):540-6. doi: 10.1002/jor.20157.

    PubMed 17205556

  • Mundermann A, Dyrby CO, Andriacchi TP. Secondary gait changes in patients with medial compartment knee osteoarthritis: increased load at the ankle, knee, and hip during walking. Arthritis Rheum. 2005 Sep;52(9):2835-44. doi: 10.1002/art.21262.

    PubMed 16145666

  • Mundermann A, Dyrby CO, Hurwitz DE, Sharma L, Andriacchi TP. Potential strategies to reduce medial compartment loading in patients with knee osteoarthritis of varying severity: reduced walking speed. Arthritis Rheum. 2004 Apr;50(4):1172-8. doi: 10.1002/art.20132.

    PubMed 15077299

  • Nuesch C, Huber C, Paul J, Henninger HB, Pagenstert G, Valderrabano V, Barg A. Mid- to Long-term Clinical Outcome and Gait Biomechanics After Realignment Surgery in Asymmetric Ankle Osteoarthritis. Foot Ankle Int. 2015 Aug;36(8):908-18. doi: 10.1177/1071100715577371. Epub 2015 Mar 20.

    PubMed 25795650

  • Nuesch C, Valderrabano V, Huber C, Pagenstert G. Effects of supramalleolar osteotomies for ankle osteoarthritis on foot kinematics and lower leg muscle activation during walking. Clin Biomech (Bristol). 2014 Mar;29(3):257-64. doi: 10.1016/j.clinbiomech.2013.12.015. Epub 2013 Dec 31.

    PubMed 24445126

  • Nuesch C, Barg A, Pagenstert GI, Valderrabano V. Biomechanics of asymmetric ankle osteoarthritis and its joint-preserving surgery. Foot Ankle Clin. 2013 Sep;18(3):427-36. doi: 10.1016/j.fcl.2013.06.002. Epub 2013 Jul 24.

    PubMed 24008209

  • Nuesch C, Valderrabano V, Huber C, von Tscharner V, Pagenstert G. Gait patterns of asymmetric ankle osteoarthritis patients. Clin Biomech (Bristol). 2012 Jul;27(6):613-8. doi: 10.1016/j.clinbiomech.2011.12.016. Epub 2012 Jan 18.

    PubMed 22261013

Questions about this trial

What is this clinical trial studying?

An observational study of Ankle Osteoarthritis and Knee Osteoarthritis, run by University Hospital, Basel, Switzerland 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 1 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 15 Nov 2019. 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?

symmetry index (time frame: up to 6 months). 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 NCT02489188, which also lists 12 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 15 Nov 2019.

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