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Randomized Controlled Trial of Dynamic Balance Training in People With Knee Osteoarthritis

5. juni 2016 opdateret af: University of British Columbia

The Effect of Dynamic Balance Training on Balance and Physical Function in Those With Knee Osteoarthritis

There is a high prevalence of falls in those with knee osteoarthritis (OA) compared to healthy older adults. Balance is a key element of function that allows individuals to maintain posture and respond to perturbations, and poor balance control, a risk factor for falls, has been noted in those with knee OA. There is a lack of research guiding treatment for balance deficits in knee OA, with interventions aimed at improving balance deficits in those with knee OA having mixed results. Targeted dynamic balance interventions in other patient populations have been shown to significantly improve dynamic balance control and physical function. If results similar to such populations can be achieved, such a program may produce a significant reduction in functional disability in the knee OA population and improve quality of life. The purpose of this study is to examine the effect of a 10-week targeted dynamic balance intervention on dynamic balance and physical function in people with knee OA. This will be a randomized controlled trial (RCT).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

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

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

50 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • age 50 - 80 years (to meet the American College of Rheumatology clinical definition of OA)
  • radiographically confirmed knee OA in the medial compartment of the tibiofemoral joint
  • predominance of pain/tenderness over the medial (inside) region of the knee

Exclusion Criteria:

  • articular cartilage degradation in the lateral tibiofemoral compartment greater than the medial
  • inflammatory arthritic condition
  • history of knee or hip replacement surgery
  • recent use of corticosteroids (oral or via injection, within last 6 months)
  • pain originating predominantly from the patellofemoral joint
  • inability to ambulate without a gait aid
  • non-English speaking
  • recent (within 6 months) arthroscopic knee surgery
  • significant hip or back pain (limits the ability to perform the testing)
  • Neurological, musculoskeletal or other condition that affects movement ability or balance (i.e. stroke, diabetes, Parkinson's, heart attack, multiple sclerosis, fibromyalgia)

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Wait list
Wait list control group. Participants will be placed on the wait list and asked to maintain their current routine and level of activity during the 10 week period. Control group participants will receive the dynamic balance training program in a single training session after the followup (second testing session at 10 weeks).
Eksperimentel: Treatment (balance training)
Targeted dynamic balance training. Dynamic balance training will consist of progressive exercise training over three phases, with exercises emphasising dynamic balance control, muscle strength and proprioception. Exercises will be performed four times per week for ten weeks. Exercises will be taught and supervised by a trained kinesiologist. Difficulty of exercises will be increased progressively over time by increasing resistance, time of timed exercises, and distance of walking exercises. Exercises will be progressed to different exercises in each new phase (total 3 phases). Participants will complete six treatment sessions at the university (during weeks 1, 2, 3, 5, 7, and 9) that will be included in the total number of sessions per week. All other sessions will be performed at home.
Andet: Targeted dynamic balance training
Participants in this study group will complete dynamic balance training exercises four times per week, for ten weeks. Exercise sessions at the university will last approximately one hour, and home exercise sessions will take approximately 30 minutes to complete. Exercises will emphasize dynamic balance control, muscle strength and proprioception and will be progressed over three phases during the ten weeks (with more difficult exercises phased in, and exercises that have been mastered phased out).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in dynamic balance and mobility from baseline
Tidsramme: 0, 10 weeks
The Community Balance and Mobility Scale (CB&M) will be used to assess dynamic balance and mobility. The CB&M is a scale designed to assess dynamic balance and mobility and is administered by a trained assessor. The scale consists of 13 items including bending, walking, turning, and stair descent, with a maximum possible score of 96 and minimum score of 0. The scale has been validated and deemed reliable for use in the knee osteoarthritis population.
0, 10 weeks
Change in self-reported physical function from baseline
Tidsramme: 0, 10 weeks
The Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) will be used to assess self-reported physical function. The WOMAC physical function subscale consists of 17 questions assessing physical function capabilities during activities of daily living.
0, 10 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in knee pain from baseline
Tidsramme: 0, 10 weeks
Average pain over the previous week will be assessed using an 11-point numerical rating scale (0 = no pain; 10 = worst pain possible).
0, 10 weeks
Change in fear of pain from baseline
Tidsramme: 0, 10 weeks
The Brief Fear of Movement Scale will be used to assess fear of pain. This scale is based on the widely used Tampa Scale of Kinesiophobia and contains 6 questions that evaluate fear of pain, movement and re-injury. The scale has been validated in individuals with OA.
0, 10 weeks
Change in self-reported physical activity level from baseline
Tidsramme: 0, 10 weeks
The Physical Activity Scale for the Elderly score (PASE) will be used to measure self-reported physical activity level. This valid and reliable self-report instrument measures the type and level of recreational and occupational physical activity in the previous week.
0, 10 weeks
Change in knee joint proprioception from baseline
Tidsramme: 0, 10 weeks
Knee joint proprioception will be measured using a knee joint repositioning task, previously used in those with OA to assess joint proprioception. Proprioception will be assessed in three randomly chosen target positions (15°, 30°, and 60° of knee flexion) while the participant is seated on an isokinetic dynamometer.
0, 10 weeks
Change in muscle strength from baseline
Tidsramme: 0, 10 weeks
Maximal concentric and eccentric muscle strength of the plantarflexors, quadriceps, and hamstrings will be measured using the same isokinetic dynamometer as for the knee joint repositioning task.
0, 10 weeks
Change in knee joint range of motion from baseline
Tidsramme: 0, 10 weeks
Range of motion will be measured using a goniometer, similar to other studies of knee OA. Participants will be asked to flex and extend their knee joint while supine.
0, 10 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ratio of number of exercise sessions attended to the maximum
Tidsramme: 10 weeks
Adherence to the exercise program will be assessed by calculating the number of exercise sessions attended divided by the maximum number of sessions.
10 weeks
Number of participants with adverse events
Tidsramme: 10 weeks
Adverse events experienced due to the intervention (i.e. increased knee pain) will be recorded weekly by participants.
10 weeks
Change in medication use
Tidsramme: 10 weeks
Any change in pharmacological use by participants will be recorded.
10 weeks
Change in co-interventions
Tidsramme: 10 weeks
Other therapies that participants may be pursuing will be recorded.
10 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

University of British Columbia

Samarbejdspartnere

Arthritis Health Professions Association

Efterforskere

  • Ledende efterforsker: Michael A Hunt, PT, PhD, University of British Columbia

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. juni 2014

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

1. april 2014

Først indsendt, der opfyldte QC-kriterier

1. april 2014

Først opslået (Skøn)

4. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. juni 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2016

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • H14-00587
  • AHPA-TAS- 14-001 (Andet bevillings-/finansieringsnummer: AHPA/The Arthritis Society)

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 .

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