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Knee Stability Training for Knee Osteoarthritis (OA)

23. januar 2013 opdateret af: University of Pittsburgh

Knee Stability Training in Individuals With Knee Osteoarthritis

People with knee osteoarthritis (OA) frequently complain of knee instability. This study will test whether certain exercises can improve knee stability, reduce pain, and improve physical function in people with knee OA.

Study hypotheses: 1) Participants in the stability training group will demonstrate less pain and higher levels of physical function, based on self-report measures of pain and function (WOMAC, Lower Extremity Function Scale), and less time to complete the Get Up and Go test, a physical performance measure of function. 2) During walking and the step down task, participants in the stability training group will demonstrate greater knee motion during weight bearing, greater vertical ground reaction forces and loading rates, and reduced ratios of co-contraction between quadriceps/hamsting and tibialis anterior/gastrocnemius muscle pairs compared to the standard group. Participants in the stability group will also demonstrate greater step lengths, single limb support times, and average walking velocity compared to the standard group.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Traditional exercise therapy for knee OA primarily focuses on lower limb strength and joint motion deficits. Recent evidence has suggested that changes in lower limb biomechanical factors during weight bearing activities may have substantial impact on physical function and disease progression in individuals with knee OA. The effectiveness of exercise therapy programs might be improved by incorporating balance and agility training techniques (knee stability training). The aim of this trial is to test the effectiveness of supplementing traditional exercise therapy with knee stability training techniques tailored for individuals with knee OA.

Participants will be randomly assigned to one of two groups. The first group will participate in a standard rehabilitation program of traditional exercise therapy for knee OA. The second group will participate in a standard rehabilitation program supplemented with a knee stability program. Study visits will occur at study entry, 2 months, 6 months, and 1 year. At each study visit, changes in pain, physical function, and biomechanical factors will be assessed. This study will last for one year.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

231

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15260
        • University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Meet the 1986 American College of Rheumatology (ACR) clinical criteria for knee osteoarthritis
  • Grade II or greater Kellgren and Lawrence radiographic changes

Exclusion Criteria:

  • History of two or more falls within the year prior to study entry
  • Unable to walk a distance of 100 feet without an assistive device or a rest period
  • Total knee arthroplasty
  • Uncontrolled hypertension
  • History of cardiovascular disease
  • History of neurological disorders that affect lower extremity function such as stroke or peripheral neuropathy
  • Corticosteroid injection to the quadriceps or patellar tendon in the past month, or 3 or more within the past year
  • Quadriceps tendon rupture, patellar tendon rupture, or patellar fracture that could place them at risk of re-injury during quadriceps strength testing
  • Pregnancy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Traditional exercise program supplemented with knee stability training activities
Andet: Knee stability training
The addition of agility and perturbation training techniques to the traditional exercise program
Aktiv komparator: 2
Traditional exercise program
Andet: Traditional exercise therapy for knee osteoarthritis
Exercises include stretching, strengthening, and aerobic exercise

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Western Ontario and McMaster OA index (WOMAC)
Tidsramme: Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Lower Extremity Function Scale
Tidsramme: Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Get Up and Go test (a physical performance measure of function)
Tidsramme: Measured at baseline, 2 months, 6 months
Measured at baseline, 2 months, 6 months
Knee Outcome Survey - Activities of Daily Living Scale
Tidsramme: Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year

Sekundære resultatmål

Resultatmål
Tidsramme
Cartilage morphology changes as measured by MRI
Tidsramme: Measured at baseline, 1 year
Measured at baseline, 1 year
Physical Activity Scale for the Elderly
Tidsramme: Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Quadriceps strength and activation
Tidsramme: Measured at baseline, 2 months, 6 months
Measured at baseline, 2 months, 6 months
Radiographic severity of OA
Tidsramme: Measured at baseline, 1 year
Measured at baseline, 1 year
Fear Avoidance questionnaire for the knee
Tidsramme: Measured at baseline, 2months, 6 months, 1 year
Measured at baseline, 2months, 6 months, 1 year
Beck Anxiety Index
Tidsramme: Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Center for Epidemiological Studies Depression Scale
Tidsramme: Measured at baseline, 2 months, 6 months, 1 year
Measured at baseline, 2 months, 6 months, 1 year
Motion analysis variables (knee motion, vertical ground reaction force, loading rates, knee adduction/abduction moment, and lower extremity muscle co-contractions during walking and a step-down task)
Tidsramme: Measured at baseline, 2 months, 6 months
Measured at baseline, 2 months, 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pittsburgh

Samarbejdspartnere

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Efterforskere

  • Ledende efterforsker: G. Kelley Fitzgerald, PhD, PT, University of Pittsburgh, Department of Physical Therapy, School of Health and Rehabilitation Sciences

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2004

Primær færdiggørelse (Faktiske)

1. december 2008

Studieafslutning (Faktiske)

1. december 2008

Datoer for studieregistrering

Først indsendt

3. marts 2004

Først indsendt, der opfyldte QC-kriterier

3. marts 2004

Først opslået (Skøn)

4. marts 2004

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

24. januar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. januar 2013

Sidst verificeret

1. januar 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NIAMS-117
  • R01AR048760-01A2 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Ledsygdomme

Kliniske forsøg med Knee stability training

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