- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02489188
Gait Asymmetry Assessed Using Portable Gait Analysis System (Asymmetry)
November 14, 2019 updated by: University Hospital, Basel, Switzerland
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a cross-sectional study.
Pre- and post-treatment data will only be collected in patients undergoing routine orthopaedic treatment.
Study Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Basel Stadt
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Basel, Basel Stadt, Switzerland, 4031
- University Hospital Basel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
healthy subjects
|
|
|
ankle osteoarthritis
patients with ankle osteoarthritis scheduled for arthroplasty
|
patients, who are scheduled for arthroplasty, will be measured before and on average 6 months after surgery
patients, who are scheduled for manual therapy, will be measured before, immediately and on average 1 week after treatment
|
|
knee osteoarthritis
patients with knee osteoarthritis scheduled for arthroplasty
|
patients, who are scheduled for arthroplasty, will be measured before and on average 6 months after surgery
patients, who are scheduled for manual therapy, will be measured before, immediately and on average 1 week after treatment
|
|
hip osteoarthritis
patients with hip osteoarthritis scheduled for arthroplasty
|
patients, who are scheduled for arthroplasty, will be measured before and on average 6 months after surgery
patients, who are scheduled for manual therapy, will be measured before, immediately and on average 1 week after treatment
|
|
lumbar spinal stenosis
patients with lumbar spinal stenosis scheduled for lumbar spinal stenosis decompression
|
patients, who are scheduled for manual therapy, will be measured before, immediately and on average 1 week after treatment
patients, who are scheduled for lumbar spinal stenosis decompression, will be measured before and on average 6 months after surgery
|
|
muscle contracture
patients with functionally limited range of motion at the knee because of muscle contracture scheduled for manual therapy
|
patients, who are scheduled for manual therapy, will be measured before, immediately and on average 1 week after treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
symmetry index
Time Frame: up to 6 months
|
gait asymmetry assessed using a portable and laboratory gait analysis systems
|
up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in symmetry index
Time Frame: up to 6 months
|
changes in gait asymmetry assessed using a portable and laboratory gait analysis systems
|
up to 6 months
|
|
maximum isokinetic joint moment [Nm]
Time Frame: up to 6 months
|
isokinetic muscle strength
|
up to 6 months
|
|
relative electromyographic (EMG) intensity
Time Frame: up to 6 months
|
electromyographic activity normalised to activity during maximum voluntary contraction
|
up to 6 months
|
|
differences between maximum flexion and extension [degrees]
Time Frame: up to 6 months
|
passive range of motion
|
up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Annegret Mündermann, PhD, University Hospital, Basel, Switzerland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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, Avon). 2013 Aug;28(7):762-9. doi: 10.1016/j.clinbiomech.2013.07.001. Epub 2013 Jul 29.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Arthritis Rheum. 2004 Dec;50(12):4073.
- 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.
- 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, Avon). 2014 Mar;29(3):257-64. doi: 10.1016/j.clinbiomech.2013.12.015. Epub 2013 Dec 31.
- 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.
- Nuesch C, Valderrabano V, Huber C, von Tscharner V, Pagenstert G. Gait patterns of asymmetric ankle osteoarthritis patients. Clin Biomech (Bristol, Avon). 2012 Jul;27(6):613-8. doi: 10.1016/j.clinbiomech.2011.12.016. Epub 2012 Jan 18.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2015
Primary Completion (Actual)
September 30, 2019
Study Completion (Actual)
September 30, 2019
Study Registration Dates
First Submitted
June 23, 2015
First Submitted That Met QC Criteria
June 30, 2015
First Posted (Estimate)
July 2, 2015
Study Record Updates
Last Update Posted (Actual)
November 15, 2019
Last Update Submitted That Met QC Criteria
November 14, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-139
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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