Clinical trial NCT02489188: Gait Asymmetry Assessed Using Portable Gait Analysis System
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Osteoarthritis
Knee Osteoarthritis
Hip Osteoarthritis
Lumbar Spine Stenosis
Muscle Contracture
Keywords: gait asymmetry
joint angles
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: symmetry index
timeFrame: up to 6 months
Secondary outcomes:
measure: change in symmetry index
timeFrame: up to 6 months
measure: maximum isokinetic joint moment [Nm]
timeFrame: up to 6 months
measure: relative electromyographic (EMG) intensity
timeFrame: up to 6 months
measure: differences between maximum flexion and extension [degrees]
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Annegret Mündermann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.