NCT02489188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

November 15, 2019

Status Verified

November 1, 2019

Enrollment Period

4.3 years

First QC Date

June 23, 2015

Last Update Submit

November 14, 2019

Conditions

Keywords

gait asymmetryjoint angles

Outcome Measures

Primary Outcomes (1)

  • symmetry index

    gait asymmetry assessed using a portable and laboratory gait analysis systems

    up to 6 months

Secondary Outcomes (4)

  • change in symmetry index

    up to 6 months

  • maximum isokinetic joint moment [Nm]

    up to 6 months

  • relative electromyographic (EMG) intensity

    up to 6 months

  • differences between maximum flexion and extension [degrees]

    up to 6 months

Study Arms (6)

ankle osteoarthritis

patients with ankle osteoarthritis scheduled for arthroplasty

Procedure: arthroplastyOther: manual therapy

knee osteoarthritis

patients with knee osteoarthritis scheduled for arthroplasty

Procedure: arthroplastyOther: manual therapy

hip osteoarthritis

patients with hip osteoarthritis scheduled for arthroplasty

Procedure: arthroplastyOther: manual therapy

lumbar spinal stenosis

patients with lumbar spinal stenosis scheduled for lumbar spinal stenosis decompression

Other: manual therapyProcedure: lumbar spinal stenosis decompression

muscle contracture

patients with functionally limited range of motion at the knee because of muscle contracture scheduled for manual therapy

Other: manual therapy

healthy subjects

healthy subjects

Interventions

arthroplastyPROCEDURE

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

ankle osteoarthritiship osteoarthritisknee osteoarthritis

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

ankle osteoarthritiship osteoarthritisknee osteoarthritislumbar spinal stenosismuscle contracture

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

lumbar spinal stenosis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (12)

  • 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.

    PMID: 23906936BACKGROUND
  • 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.

    PMID: 23739275BACKGROUND
  • 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.

    PMID: 22653634BACKGROUND
  • 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.

    PMID: 22482665BACKGROUND
  • 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.

    PMID: 17678933BACKGROUND
  • 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.

    PMID: 17205556BACKGROUND
  • 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.

    PMID: 16145666BACKGROUND
  • 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.

    PMID: 15077299BACKGROUND
  • 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.

    PMID: 25795650BACKGROUND
  • 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.

    PMID: 24445126BACKGROUND
  • 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.

    PMID: 24008209BACKGROUND
  • 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.

    PMID: 22261013BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritis, HipContracture

Interventions

ArthroplastyMusculoskeletal Manipulations

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesMuscular Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Annegret Mündermann, PhD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2015

First Posted

July 2, 2015

Study Start

June 1, 2015

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

November 15, 2019

Record last verified: 2019-11

Locations