- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07253714
EFFEKTEN AV PROPRIOCEPTIV TRENING PÅ CERVICAL PROPRIOCEPSJON, KINESIOFOBI OG SMERTEKATASTROFERINGSNIVÅER HOS SARKOPENISKE GERIATRISKE PERSONER SOM BOR PÅ SYKEHJEM
Denne studien undersøkte effektene av trening i cervikal proprioception på cervikal proprioception, kinesiofobi og smertekatastrofisering hos sarkopene sykehjemspasienter.
I denne randomiserte kontrollerte studien ble 63 sykehjemspasienter screenet for sarkopeni basert på EWGSOP2-kriteriene, som inkluderer vurderinger av håndgrepstyrke (Jamar-dynamometer), fysisk ytelse (4-meters gangtest), og muskelmasse evaluert ved bioelektrisk impedansanalyse. Trettien pasienter diagnostisert med sarkopeni ble tilfeldig tildelt enten en kontrollgruppe (n = 17), som fullførte 12 veiledede økter med konvensjonelle øvelser (holdnings-, cervikal bevegelsesutstrekning- og isometriske øvelser) over seks uker, eller en eksperimentell gruppe (n = 14), som mottok ytterligere 12 økter med cervikale proprioceptive øvelser. Begge gruppene ble evaluert før og etter intervensjonen. Cervikal leddposisjonssans, kinesiofobi, smertekatastrofisering, ble vurdert ved hjelp av Joint Position Error Test; Tampa Scale of Kinesiophobia; Pain Catastrophizing Scale.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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çankaya
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Ankara, çankaya, Tyrkia (Türkiye), 06530
- Nevia Oran Nursing Home
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier;
- Å være 65 år eller eldre,
- Å være diagnostisert med sarkopeni,
- Å ha minst 91 poeng eller mer i henhold til Barthels indeks for daglige livsaktiviteter (være lett avhengig eller helt uavhengig),
- Å ha 24 poeng eller mer i henhold til mini-mental vurdering, som regnes som mentalt sunt.
Eksklusjonskriterier;
- Å ha en funksjonsnedsettelse (som lem, syn, hørselstap),
- Å ha en alvorlig nevrologisk, ortopedisk eller revmatologisk lidelse som kan påvirke proprioepsjon,
- Å ha ukontrollert hypertensjon/diabetes,
- Å ha smerter i ryggraden og/eller ekstremiteter,
- Å ha en psykiatrisk sykdomsdiagnose.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Eksperimentell gruppe
Cervikale proprioceptive øvelser og klassiske øvelser ble anvendt.
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Deltakere i kontrollgruppen mottok klassisk trening i 6 uker.
Deltakere i den eksperimentelle gruppen mottok cervikale proprioepsjonsøvelser i tillegg til klassisk trening i 6 uker.
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Aktiv komparator: Kontrollgruppe
Klassisk trening (Cervical range of motion exercise+posture exercise+isometric exercises) ble kun anvendt.
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Deltakere i kontrollgruppen mottok klassisk trening i 6 uker.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Vurdering av cervikal proprioepsjon
Tidsramme: 10 måneder
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Cervikalt proprioepsjon ble vurdert ved bruk av leddposisjonsfeiltest.
Mens deltakeren satt, vendte de seg mot et brett plassert 90 cm unna i høyde med hodet, som besto av konsentriske sirkler (40 cm diameter, 1-cm trinn), og bar en lue med en montert laserpeker. Deltakeren først justerte laseren med midtpunktet for å etablere nøytral posisjon, deretter - med åpne øyne - ble veiledet gjennom fleksjon, ekstensjon, høyre/venstre rotasjon, og høyre/venstre lateralfleksjon, og returnerte til nøytral etter hver bevegelse.
De samme seks bevegelsene ble deretter aktivt utført med lukkede øyne.
Seks repetisjoner ble fullført for hver retning, og punktet der laseren stoppet ble merket på brettet etter hver forsøk.
Gjennomsnittet av disse punktene ble beregnet, og vinkelavvik fra målet ble bestemt ved bruk av arctan-metoden basert på den faste avstanden til brettet.
Et avvik på mer enn 4 grader ble ansett som indikasjon på nedsatt proprioepsjon.
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10 måneder
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Vurdering av kinesiofobi
Tidsramme: 10 måneder
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Kinesiofobi ble vurdert ved bruk av Kinesiofobi Årsaksskalaen (KCS).
Utviklet av Kocjan og Knapik (2014), identifiserer skalaen de biologiske og psykologiske kildene til bevegelsesfrykt og bidrar til forståelsen av de underliggende årsakene til redusert motorisk aktivitet.
Den består av to domener: biologisk og psykologisk.
Det biologiske domenet inkluderer morfologiske faktorer, bevegelseskrav, energiresurser, biologiske drifter, negative erfaringer, motorisk kompetanse og tro relatert til kroppspleie, mens det psykologiske domenet vurderer faktorer som selvtillit, mestringstro og sosial interaksjon som bidrar til unngåelsesatferd.
Den tyrkiske validitets- og pålitelighetsstudien ble utført av Çayır et al. (2020).
Skalaen består av 20 elementer vurdert på en 5-punkts Likert-skala (1 = sterkt uenig, 5 = sterkt enig).
Høyere poengsummer indikerer større bevegelsesfrykt.
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10 måneder
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Vurdering av smertekatastrofisering
Tidsramme: 10 måneder
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Smertekatastrofisering ble vurdert ved hjelp av Smertekatastrofiseringsskalaen (PCS), et 13-punkts mål som evaluerer maladaptive tanker og følelser relatert til smerte.
Skalaen inkluderer tre underdimensjoner: hjelpeløshet, forstørrelse og grubling.
Hvert element poengsummes på en skala fra 0 til 4, og underskala-poengsummer oppnås ved å summere de tilsvarende elementene; den totale PCS-poengsummen beregnes som summen av alle elementer.
Den tyrkiske validitets- og pålitelighetsstudien ble utført av Uğurlu et al. (2017).
Totale poengsummer varierer fra 0 til 52, med høyere poengsummer som indikerer større smertekatastrofisering. Poengsummer over 30 reflekterer klinisk signifikante nivåer av katastrofisering.
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10 måneder
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
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