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Gait Modification for Knee Osteoarthritis (SENSMOD)

15. oktober 2020 oppdatert av: Michael Hunt, University of British Columbia

Foot Progression Angle Modification: an Exploratory Six-week Intervention in People With Knee Osteoarthritis

This randomized clinical trial will compare the changes in performance, biomechanical and clinical outcomes before and after a six-week gait modification intervention. Participants with knee osteoarthritis will attend in-lab assessments and practice, while also performing daily, at-home walking tracked using a custom sensorized shoe.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Greater toe-in or toe-out angles during walking are potential biomechanical management strategies for medial compartment knee osteoarthritis (OA). Multi-week clinical trials demonstrate the biomechanical efficacy and potential clinical efficacy. However, walking biomechanics have only been assessed within laboratory environments and performance of the modifications during daily at-home walking is currently unknown. Furthermore, the modifications have largely been instructed using a specific target, requiring motor learning. No study has examined whether a self-directed strategy is feasible and will produce significant improvements in biomechanical and clinical outcomes. Moreover, objective real-world performance of these modifications is unknown and may explain the previous inconsistent clinical results. This study will address these gaps. The investigators hypothesize that real-world performance of the modifications will improve over the intervention and that both groups will exhibit improvements in biomechanical and clinical outcomes at follow up.

Studietype

Intervensjonell

Registrering (Faktiske)

3

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • Motion Analysis and Biofeedback Laboratory

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Be 50 years of age or greater
  • Exhibit signs of tibiofemoral OA (a score of ≥ 2 on the Kellgren and Lawrence (KL) grading scale) predominantly in the medial compartment,
  • Self-reported knee pain ≥ 3 / 10 on a numerical rating scale of pain (NRS; 0 = "no pain" and 10 = "worst pain imaginable") during most days of the previous month
  • Are comfortable walking intermittently for 30 minutes
  • Fit into the available sizes of sensorized shoes (sizes spanning US women's 5 to men's 13)
  • Exhibit at least a 5% reduction in knee adduction moment impulse for 10 degrees of change to foot rotation measured during a screening appointment.

Exclusion Criteria:

  • Any knee surgery or intraarticular injections within the past 6 months
  • A history of joint replacement surgery or high tibial osteotomy
  • Current or recent (within 6 weeks) corticosteroid injections
  • Use of a gait aid
  • Currently on a wait list for joint replacement surgery or high tibial osteotomy
  • Any inflammatory arthritic condition
  • Any other conditions that may affect normal gait or participation in an aerobic exercise program
  • Cannot attend all required appointments.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Specific Modification Target
A 15 degree relative increase to foot progression angle
Atferdsmessig: Specific Modification Target
Participants will be instructed to increase their baseline foot progression angle by 15 degrees. Visual feedback during practice will be delivered using a mirror and guideline (tape placed on mirror). Verbal feedback will be incorporated to encourage participants to perform the modified foot progression angle as accurately as possible.
Eksperimentell: Self-directed Modification
A self-directed increase to foot progression angle that is "as much as is comfortable".
Atferdsmessig: Self-directed Modification
Participants will be instructed to modify their foot progression angle as much as is comfortable. A mirror will be used during practice for visual feedback, but no specific target or guide will be provided.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in baseline to week 7 foot rotation angle error during stance - in lab walking
Tidsramme: Baseline, Week 7
Foot rotation is the specific walking parameter that will be modified during the intervention. It is defined as the angle between the long axis of the foot (heel to toe) and the walking direction. Foot rotation will be measured via standard marker-based motion capture and sensor-based motion capture during baseline, follow up, and each practice session.
Baseline, Week 7
Weekly change in baseline foot rotation angle error during stance - at home walking and during practice sessions
Tidsramme: Baseline, Weeks 1, 2, 3, 4, 5, 6, 7
Foot rotation is the specific walking parameter that will be modified during the intervention. It is defined as the angle between the long axis of the foot and the walking direction. Foot rotation will be measured via sensor-based motion capture over each week of the intervention. Median and inter-quartile ranges will be taken as the primary summary statistic.
Baseline, Weeks 1, 2, 3, 4, 5, 6, 7

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in baseline to week 7 knee joint moment impulse
Tidsramme: Baseline, Week 7
Knee flexion and adduction moment impulses will be calculated. Participants will walk on an instrumented walkway (2 force platforms) while 14 high speed cameras track the trajectories of markers placed on boney landmarks. Moments will be calculated using an inverse dynamics approach.
Baseline, Week 7
Change in baseline to week 7 Knee Injury and Osteoarthritis Outcome Score (KOOS)
Tidsramme: Baseline, Week 7
Validated questionnaire on symptoms and functional limitations related to knee osteoarthritis. The score is expressed in percentage (0-100), with 0 representing extreme knee problems and 100 representing no knee problems.
Baseline, Week 7
Change in baseline to week 7 knee pain on a numerical rating scale
Tidsramme: Baseline, Week 7
Knee pain rated on a 0 to 10 scale. 0 = "no pain at all" and 10 = "worst pain imaginable".
Baseline, Week 7
Change in week 1 to week 7 difficulty performing the modification on a numerical rating scale
Tidsramme: Week 1, 7
Difficulty will be rated on a 0 to 10 scale. 0 = "no difficulty at all" and 10 = "most difficulty imaginable".
Week 1, 7

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of British Columbia

Etterforskere

  • Hovedetterforsker: Michael Hunt, PT, PhD, University of British Columbia

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

20. februar 2020

Primær fullføring (Faktiske)

12. mars 2020

Studiet fullført (Faktiske)

12. mars 2020

Datoer for studieregistrering

Først innsendt

3. februar 2020

Først innsendt som oppfylte QC-kriteriene

25. mars 2020

Først lagt ut (Faktiske)

27. mars 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. oktober 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • H19-02621

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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