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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02489188
Other study ID # 2015-139
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2015
Est. completion date September 30, 2019

Study information

Verified date November 2019
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date September 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design


Intervention

Procedure:
arthroplasty
patients, who are scheduled for arthroplasty, will be measured before and on average 6 months after surgery
Other:
manual therapy
patients, who are scheduled for manual therapy, will be measured before, immediately and on average 1 week after treatment
Procedure:
lumbar spinal stenosis decompression
patients, who are scheduled for lumbar spinal stenosis decompression, will be measured before and on average 6 months after surgery

Locations

Country Name City State
Switzerland University Hospital Basel Basel Basel Stadt

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (12)

Fisher DS, Dyrby CO, Mündermann 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. — View Citation

Horstmann T, Listringhaus R, Brauner T, Grau S, Mündermann 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. — View Citation

Horstmann T, Listringhaus R, Haase GB, Grau S, Mündermann 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. — View Citation

Horstmann T, Vornholt-Koch S, Brauner T, Grau S, Mündermann 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. — View Citation

Mündermann A, Asay JL, Mündermann L, Andriacchi TP. Implications of increased medio-lateral trunk sway for ambulatory mechanics. J Biomech. 2008;41(1):165-70. Epub 2007 Aug 3. — View Citation

Mündermann 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. — View Citation

Mündermann 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. Erratum in: Arthritis Rheum. 2004 Dec;50(12):4073. — View Citation

Mündermann A, Mündermann 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. — View Citation

Nüesch 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. Review. — View Citation

Nüesch 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. — View Citation

Nüesch 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. — View Citation

Nüesch 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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary symmetry index gait asymmetry assessed using a portable and laboratory gait analysis systems up to 6 months
Secondary change in symmetry index changes in gait asymmetry assessed using a portable and laboratory gait analysis systems up to 6 months
Secondary maximum isokinetic joint moment [Nm] isokinetic muscle strength up to 6 months
Secondary relative electromyographic (EMG) intensity electromyographic activity normalised to activity during maximum voluntary contraction up to 6 months
Secondary differences between maximum flexion and extension [degrees] passive range of motion up to 6 months
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