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Justerbare protesestikker

16. juli 2026 opdateret af: VA Office of Research and Development

Justerbare sokler til veteraner med underkropsamputation: Patientrapporterede resultater og tryk inden i soklen

Hvert år omkring 1500 veteraner slutter sig til de 623.000 amerikanere, der lever med en amputation af underkroppen. Mange af disse veteraner vælger den anstrengende vej til rehabilitering for at forblive gående, en proces, der omfatter ordination af en protese til underkroppen. Meget afhænger af, hvor godt deres protese sidder. En god pasform føles behagelig og muliggør en række gående aktiviteter. En dårlig pasform resulterer i ubehag, ofte ledsaget af kroniske hudproblemer, og daglige aktiviteter bliver begrænset.

Konventionelle proteseskåle er skræddersyet af en dygtig protesemager, omhyggeligt formede for at passe til veteranens stump, og der kan normalt opnås en god pasform. Disse skåle er stive, fast formede strukturer med en bulldozers robusthed, bygget til vedvarende, tung belastning. Desværre kan formen på en persons stump ændre sig over tid, så en god pasform med tiden bliver dårlig. Et estimat antyder, at en ny skål under knæet er nødvendig hvert tredje et halvt år. Udgifterne til udskiftning af skåle, der ikke længere passer, er ikke ubetydelige. Medicare-udgifter til udskiftning af eksisterende skåle under knæet og tilhørende komponenter blev estimeret til 50 millioner dollars i 2017. Vigtigt er, at Medicare estimeres at udgøre kun 20 % af markedet, hvilket antyder, at de estimerede udgifter for hele befolkningen med amputationer af underkroppen sandsynligvis er betydeligt større. En velpassende protese, der bevarer sin pasform over tid, ville tjene veteraner godt.

En potentiel løsning, der kunne få en god pasform til at vare længere, er en justerbar proteseskål. Selvom der er begrænset evidens til at støtte ordinationspraksis, har Centers for Medicare and Medicaid Services (CMS) for nylig autoriseret refusion for justerbare proteseskåle, hvilket antyder et stort behov for et sådant produkt.

For at undersøge potentialet for skadelige virkninger og hvordan veteraner muligvis bruger justerbare proteseskåle, er formålet med denne forskning at bestemme trykket på stumperne fra en justerbar proteseskål under aktiviteter af varierende intensitet og de aktiviteter, der udløser justeringer.

Der vil blive gennemført et laboratoriebaseret forsøg med menneskelige forsøgspersoner ved hjælp af en brugerdefineret sensor placeret inde i det justerbare panel i en justerbar proteseskål leveret af studiet. Deltagere vil vænne sig til den justerbare proteseskål i to uger i feltet og derefter vende tilbage til laboratoriet for at udføre syv aktiviteter. Trykket inde i protesen vil blive målt under disse aktiviteter. Deltagere vil også rapportere, hvor stramt deres skål føles efter hver aktivitet.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Protesesokler, der muliggør ambulatorisk mobilitet for veteraner med amputation af nedre ekstremitet, er typisk stive, overdrevet stærke strukturelle elementer med fast form, der fungerer som grænsefladen mellem kroppen og omgivelserne. En veterans protesesokkel er skræddersyet; den er beregnet til at passe én person og kun én person.

Ændringer i pasform efter udleveringen af en protese er mere almindelige end ikke. Ændringer relateret til kropsmasse, muskelatrofi eller personlig fitness kan ske over måneder, mens ændringer på grund af kost eller diabetiske komplikationer kan ske på timer. Hvis uoverensstemmelsen i form mellem den resterende lemstump og soklen er lille, kan veteranen håndtere forskellen ved at tage på eller tage af resterende lemstrømper. Denne tilgang er ikke ideel, da nogle patienter er mere tilbøjelige til at anvende praksissen end andre. Hvis uoverensstemmelsen i form er stor, kræves der normalt en ny protesesokkel. Uanset om den er lille eller stor, kan manglende håndtering af ændringer negativt påvirke deres brug af protesen og sundheden af deres resterende lemstump.

På trods af dens begrænsninger har den fastformede protesesokkel været standardbehandlingen i årtier. Imidlertid fandt en potentielt betydningsfuld begivenhed sted i april 2024, da Centers for Medicare and Medicaid Services (CMS) autoriserede refusion for justerbare protesesokler. Selvom den nye autorisation muliggør betaling for dens udlevering, er der lille evidens til at hjælpe patienter, udbydere og betalere med at forstå de potentielle resultater af at ordinere en justerbar protesesokkel.

Formålet med denne forskning er at afdække, hvordan veteraner bruger justerbare protesesokler ved at måle trykket påført den resterende lemstump af en justerbar protesesokkel under aktiviteter af varierende intensitet og identificere, hvilke aktiviteter der kan fremkalde en justering. Forskerne vil rekruttere ambulatoriske veteraner med unilaterale transtibiale amputationer (n = 25) og tilpasse dem med en justerbar protesesokkel.

Deltagere vil bære en instrumenteret justerbar protesesokkel efter at have båret en ikke-instrumenteret duplikat justerbar protesesokkel i to uger. Deltagere vil få lov til at gå rundt i 5 til 10 minutter, mens forskningsprotetikeren kontrollerer pasform og justering af studieprotesen. Trykmålinger vil derefter blive indsamlet mens man sidder, står og går. Stående og gående aktiviteter vil blive udført i tilfældig rækkefølge, afbrudt af 1-minutters sidende pauser, hvor deltageren vil frigive trykket på det justerbare panel. Gå-forsøgene vil blive udført på et løbebånd.

  • Siddende pause 5 min

  • Tilfældig rækkefølge med 1 min siddende pause mellem hver:

    • Stå 1 min
    • Gå med selvvalgt hastighed 1 min
    • Gå op ad 10% stigning med selvvalgt hastighed 1 min
    • Gå ned ad 10% stigning med selvvalgt hastighed 1 min
    • Gå 15% hurtigere end selvvalgt hastighed 1 min
    • Gå med selvvalgt hastighed 10 min Lige før starten af hver aktivitet vil deltageren blive fortalt, hvad den næste aktivitet er, og bedt om at justere deres sokkel i overensstemmelse hermed. Deltagere vil også være frie til at foretage justeringer under en aktivitet. I denne situation vil varigheden af aktiviteten blive forlænget, således at der er 1 minut af aktiviteten tilbage ved den nye justeringsindstilling. Ved afslutningen af hver aktivitet vil stramheden blive vurderet ved hjælp af et spørgeskemaspørgsmål. Specifikt vil forskerne efter hver aktivitet bede hver deltager om at vurdere stramheden af deres justerbare protesesokkel i øjeblikket på en skala fra 0 til 10.

Generelt antager forskerne, at trykket påført den resterende lemstump vil afhænge af aktiviteten, ligesom stramheden vil gøre det.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

25

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater, 98108-1532
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA
        • Ledende efterforsker:
          • Glenn K Klute, PhD
        • Kontakt:

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Veteraner med amputation i nedre ekstremitet
  • har en unilateralt transtibial amputation
  • bærer en protese i mindst 4 timer om dagen ifølge selvrapportering
  • mindst et år efter amputationen
  • har en modular protese, der inkluderer en fire-bolt sokkelforbindelse
  • kan gå på løbebånd

Eksklusionskriterier:

  • har en uhensigtsmæssig pasform og suspension med deres nuværende protese, og en god pasform kan ikke opnås med kliniske ressourcer
  • har nuværende hudirritation eller skade på den resterende lem, artrose, skade eller smerter, der forstyrrer gangfunktionen

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Justerbar protesehylster
Deltagerne vil bære en justerbar protesesokkel.
Enhed: Justerbart protesehylster
Undersøgerne vil fremstille og samle en justerbar protesestøtte til hver deltager, hvis form er en kopi af deres eksisterende, ordinerede protesestøtte. Vi vil tilføje tre justerbare paneler til protesestøtten, som vil være placeret over den mediale og laterale proximale tibia-region samt den posteriore gastrocnemius-region. Panelernes position kan justeres ind og ud ved hjælp af en kabelmekanisme.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Distal end pressure while seated (5 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments
A pressure transducer will record the distal end residual limb pressure while the participant is seated for 5 minutes. The first four minutes of data will be truncated. The remaining first and last fifteen seconds of the fifth minute will also be truncated. The mean pressure will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments
Distal end pressure while standing (1 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments
A pressure transducer will record the distal end residual limb pressure while the participant stands for 1 minute. The first and last fifteen seconds will be truncated. The mean pressure will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments
Distal end pressure while walking at self-selected speed (1 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the distal end residual limb pressure while the participant walks at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Distal end pressure while walking up 10% slope at self-selected speed (1 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the distal end residual limb pressure while the participant walks up 10% slope at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Distal end pressure while walking down 10% slope at self-selected speed (1 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the distal end residual limb pressure while the participant walks down 10% slope at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Distal end pressure while walking 15% faster than self-selected speed (1 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the distal end residual limb pressure while the participant walks 15% faster than self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Distal end pressure while walking at self-selected speed (10 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the distal end residual limb pressure while the participant walks at self-selected speed for 10 minutes. The first nine minutes of data will be truncated. The remaining first and last fifteen seconds of the tenth minute will also be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while seated (5 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant is seated for 5 minutes. The first four minutes of data will be truncated. The remaining first and last fifteen seconds of the fifth minute will also be truncated. The mean pressure will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while standing (1 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant stands for 1 minute. The first and last fifteen seconds will be truncated. The mean pressure will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking at self-selected speed (1 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant walks at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking up 10% slope at self-selected speed (1 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant walks up 10% slope at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking down 10% slope at self-selected speed (1 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant walks down 10% slope at self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking 15% faster than self-selected speed (1 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant walks 15% faster than self-selected speed for 1 minute. The first and last fifteen seconds will be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Adjustable posterior panel pressure while walking at self-selected speed (10 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
A pressure transducer will record the adjustable posterior panel pressure while the participant walks at self-selected speed for 10 minutes. The first nine minutes of data will be truncated. The remaining first and last fifteen seconds of the tenth minute will also be truncated. The mean peak pressure from each step with the prosthesis will be calculated from the remaining 30 seconds of each trial.
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Tightness while seated (5 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while standing (1 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking at self-selected speed (1 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking up 10% slope at self-selected speed (1 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking down 10% slope at self-selected speed (1 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking 15% faster than self-selected speed (1 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
Tightness while walking at self-selected speed (10 minute bout)
Tidsramme: After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.
After each activity, the participant will rate the tightness of their adjustable prosthetic socket at the moment. On a 0 - 10 scale, if 0 represents the loosest socket fit that can be imagined, and 10 represents the tightest socket fit that can be imaged, what score represents the socket tightness at the moment?
After a two-week acclimation period where the participant wears an adjustable prosthetic socket in the home, community, and work environments.

Samarbejdspartnere og efterforskere

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

Sponsor

VA Office of Research and Development

Efterforskere

  • Ledende efterforsker: Glenn K Klute, PhD, VA Puget Sound Health Care System Seattle Division, Seattle, WA

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 (Anslået)

1. oktober 2026

Primær færdiggørelse (Anslået)

15. januar 2029

Studieafslutning (Anslået)

1. august 2029

Datoer for studieregistrering

Først indsendt

2. februar 2026

Først indsendt, der opfyldte QC-kriterier

2. februar 2026

Først opslået (Faktiske)

9. februar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • RRD2-010-25M
  • 1I01RD002103-01 (Andet bevillings-/finansieringsnummer: US Department of Veterans Affairs)
  • 1924445 (Anden identifikator: gov.irbnet.org)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Endelige datasæt, der ligger til grund for alle publikationer, der fremkommer af den foreslåede forskning, vil blive delt uden for VA. Et de-identificeret, anonymiseret datasæt vil blive oprettet og tilgængeligt for offentligheden via en VA-godkendt hjemmeside. Hvor muligt vil forskerne samarbejde med manuskriptudgivere om at linke de endelige studiedatasæt som et tillæg til publicerede manuskripter. Ved at levere de-identificerede datasæt i åbne filformater (f.eks. .txt, .xls, .mat) sammen med klart dokumenterede instruktioner til behandling, vil interesserede modtagere være i stand til at reproducere og bygge videre på de samme teknikker, som forskerne vil skitsere i vores publikationer. En offentlig frigivelsesidentifikator for hvert enkelts datasæt (f.eks. APS_001, APS_002) vil blive oprettet og tilfældigt parret med de-identificerede studiedata. Data vil bestå af deltagerdemografi, test- og spørgeskemaresultater. Der vil ikke være nogen sporbar måde at genmatche disse data til deltageren. Vores metoder vil blive verificeret af VAPSHCS Privatlivsansvarlig.

IPD-delingstidsramme

Inden for seks måneder efter offentliggørelse af studiet afsluttende resultater.

IPD-delingsadgangskriterier

Åben adgang gennem PubMed Central, SimTK, PhysioNet eller andre lignende open-source datarepository-websites. Studieprotokollen, den statistiske analyseplan og det informerede samtykkeformular vil blive delt på clinicaltrials.gov.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

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 .

Abonner