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Biomechanics of Gait Pattern Adaptation in Patients After Total Knee Arthroplasty

21. december 2015 opdateret af: Tel-Aviv Sourasky Medical Center

This study aimed to discover the biomechanics of gait pattern adaptation in patients after a total knee replacement.

The first hypothesis of the project was that center-of-pressure manipulation at the foot during dynamic loading is capable of changing the forces, torques and muscle activation patterns of the lower limb.

The second hypothesis of the project was that patient-specific center-of-pressure manipulation at the foot combined with repetitive perturbation training over time will improve neuromuscular function, barefoot gait patterns, muscle activation patterns, pain, quality of life and energy consumption in patients after a total knee replacement.

Studieoversigt

Detaljeret beskrivelse

This study is a randomized prospective controlled study of patients after total knee arthroplasty. Patients will be recruited to the study and divided randomly into an experimental and control group. Both groups will match in terms of gender, age, pathology and clinical assessment. In addition to the intervention of the present study, all patients, whether in the experimental or control group, will carry out the usual physical therapy exercises for total knee arthroplasty as directed by their physician. The patients will be recruited and evaluated prior to surgery and for a follow-up period after surgery.

After surgery, patients in the experimental group will be fitted with a customized biomechanical device worn on the feet (Apos System, Apos - Sports and Medical Technologies Ltd. Hertzlia, Israel). The device is calibrated personally to each patient. By calibrating the device, the center-of-pressure of the foot can be manipulated during all phases of the gait cycle. The device is capable of inducing controlled perturbation during gait. The immediate effects of the device will be evaluated using center-of-pressure measurements, three-dimensional gait analyses and surface electromyography. The patients are instructed to walk with the device according to a therapy protocol (AposTherapy). Patients will be evaluated for changes in gait via three-dimensional gait analyses, muscle activation pattern changes via surface electromyography, pain, quality of life and energy consumption.

The patients in the control group will carry out the same walking exercises as the experimental group, but without the biomechanical intervention device (placebo walking shoe). The patients will be evaluated with the same tools over time as with the experimental group.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

      • Haifa, Israel
        • Biorobotics and Biomechanics Lab, Technion Israel Institute of Technology

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 til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patients scheduled for first total knee arthroplasty due to end-stage knee osteoarthritis
  • Ambulatory and active patients that can participate in gait analysis

Exclusion Criteria:

  • Prior joint surgery of either lower extremity, with the exception of arthroscopy
  • Unsteady gait
  • Back pain
  • Neurological, pulmonary or cardiovascular pathologies or risks that may affect long-term performance
  • Inability to understand or comply with the treatment protocol

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: Experimental
These patients will carry out the specified intervention of the study with the AposTherapy Biomechanical System in addition to the typical physical therapy regiment prescribed to them by their physician.
The device is comprised of four adjustable modular elements attached to foot-worn platforms that are capable of manipulating the foot's center-of-pressure and applying perturbation training throughout the gait cycle. The device allows for neuromuscular training during dynamic loading.
Aktiv komparator: Control
The patients within this group will also carry out the typical physical therapy program for total knee replacement as prescribed by their physician. The patients will carry out a similar therapy program to the experimental group, but without the study intervention device (placebo walking shoe).
Their therapy program will be similar to the experimental group, but without the treatment device (placebo walking shoe).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Gait Patterns at 6-8 weeks, 5-6 months and 11-12 months
Tidsramme: An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5-6 months and 11-12 months after surgery

Three-dimensional gait analysis of spatiotemporal, kinetic and kinematic parameters.

Surface electromyographic analysis of muscle activation patterns. Center of pressure measurements and function tests.

An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5-6 months and 11-12 months after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in Pain, Function and Quality of Life Assessments at 6-8 weeks, 5-6 months and 11-12 months
Tidsramme: An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5-6 months and 11-12 months after surgery
Includes self-evaluation questionnaires
An average of 2 weeks prior to surgery and an average of 6-8 weeks, 5-6 months and 11-12 months after surgery

Samarbejdspartnere og efterforskere

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

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. juli 2011

Primær færdiggørelse (Faktiske)

1. oktober 2014

Studieafslutning (Faktiske)

1. december 2014

Datoer for studieregistrering

Først indsendt

20. juli 2011

Først indsendt, der opfyldte QC-kriterier

7. august 2011

Først opslået (Skøn)

9. august 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. december 2015

Sidst verificeret

1. december 2015

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • TASMC 11 MS 0569-10-TLV CTIL
  • 0569-10-TLV (Registry Identifier: Institutional Review Board Sourasky Medical Center)

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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