- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04923373
Telerehabilitation After Total Knee Arthroplasty
8. juni 2021 opdateret af: Justyna Drzał-Grabiec, University of Rzeszow
Early Function Recovery in Geriatric Patients With Total Knee Arthroplasty by Telerehabilitation
The aim of this study was to assess the function, pain intensity and walking distance in patients prior to and after total knee arthroplasty, who received therapy either in a clinic under direct supervision of a physical therapist and patients who received telerehabilitation.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The study population consisted of 105 patients who had knee arthroplasty due to knee arthrosis followed by 6- weeks physiotherapy, mean age 68.5 ± 7.3 years.
The patients were randomly divided into two groups: I - telerehabilitation group (n=54), and II clinical control group (n=51), who received physiotherapy supervised by physiotherapist.
All patients were given the following tests: VAS (0-10), 6-Minute Walk Test, and KSS - Knee Society Score.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
105
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Podkarpackie
-
Rudna Mała, Podkarpackie, Polen, 36-060
- Szpital Specjalistyczny im. Świętej Rodziny
-
-
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:
- total cemented knee arthroplasty with posterior stability (PS -cruciate sacrificing, posterior stabilized),
- informed consent to participate in the study,
- full medical record,
- patients' regular control visits,
- knee degenerative disorder stage II and III according to Altman classification,
- ability to understand and independently perform the complete physiotherapeutic programme
Exclusion Criteria:
- partial arthroplasty,
- deformation aetiology other knee degenerative disorder,
- cognitive disorders resulting in inability to fill out the study questionnaire, - degenerative disorders of multiple joints,
- poor general health that prevented the patient from understanding or performing the full physiotherapeutic programme,
- intraoperative and postoperative complications preventing the patient from understanding or performing the full physiotherapeutic programme,
- lack of informed consent to participate in the study.
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: telerehabilitation
physiotherapeutic programme brochure exercises 7/week controlled by phone every week (5x in total)
|
Procedure for both groups: I pre surgery evaluation
Therapy duration: 6 weeks post-surgery II 6weeks post-surgery evaluation |
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Aktiv komparator: standard physiotherapy
Supervised physical therapy 3/ week, + physiotherapeutic programme brochure 4/week |
standard physiotherapy
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in 6 - Minute Walk Test
Tidsramme: Change from baseline- 1st measurement before total knee arthroplasty and final - 2nd measurement in 6 weeks after total knee arthroplasty and physiotherapy
|
Change in walking distance in 6 minutes ( in meters)
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Change from baseline- 1st measurement before total knee arthroplasty and final - 2nd measurement in 6 weeks after total knee arthroplasty and physiotherapy
|
|
Change in Knee Society Score
Tidsramme: Change from baseline- 1st measurement before total knee arthroplasty and final - 2nd measurement in 6 weeks after total knee arthroplasty and physiotherapy
|
Change in disability measured by Knee disability score (min 0 - max 200 points).
Higher scores mean a better outcome.
|
Change from baseline- 1st measurement before total knee arthroplasty and final - 2nd measurement in 6 weeks after total knee arthroplasty and physiotherapy
|
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Change in range of knee motion [degrees]
Tidsramme: Change from baseline- 1st measurement before total knee arthroplasty and final - 2nd measurement in 6 weeks after total knee arthroplasty and physiotherapy
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Change in knee flexion
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Change from baseline- 1st measurement before total knee arthroplasty and final - 2nd measurement in 6 weeks after total knee arthroplasty and physiotherapy
|
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Change of knee pain intensity in Visual Analogue Scale
Tidsramme: Change from baseline- 1st measurement before total knee arthroplasty and final - 2nd measurement in 6 weeks after total knee arthroplasty and physiotherapy
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Change of knee pain intensity (0-10), 0 - no pain, 10 - worst pain
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Change from baseline- 1st measurement before total knee arthroplasty and final - 2nd measurement in 6 weeks after total knee arthroplasty and physiotherapy
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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
- Moffet H, Tousignant M, Nadeau S, Merette C, Boissy P, Corriveau H, Marquis F, Cabana F, Ranger P, Belzile EL, Dimentberg R. In-Home Telerehabilitation Compared with Face-to-Face Rehabilitation After Total Knee Arthroplasty: A Noninferiority Randomized Controlled Trial. J Bone Joint Surg Am. 2015 Jul 15;97(14):1129-41. doi: 10.2106/JBJS.N.01066.
- Truszczynska-Baszak A, Dadura E, Drzal-Grabiec J, Tarnowski A. Static balance assessment in patients with severe osteoarthritis of the knee. Knee. 2020 Oct;27(5):1349-1356. doi: 10.1016/j.knee.2020.06.014. Epub 2020 Jul 27.
- Benz T, Angst F, Oesch P, Hilfiker R, Lehmann S, Mueller Mebes C, Kramer E, Verra ML. Comparison of patients in three different rehabilitation settings after knee or hip arthroplasty: a natural observational, prospective study. BMC Musculoskelet Disord. 2015 Oct 24;16:317. doi: 10.1186/s12891-015-0780-2.
- Russell TG, Buttrum P, Wootton R, Jull GA. Rehabilitation after total knee replacement via low-bandwidth telemedicine: the patient and therapist experience. J Telemed Telecare. 2004;10 Suppl 1:85-7. doi: 10.1258/1357633042614384.
- Piqueras M, Marco E, Coll M, Escalada F, Ballester A, Cinca C, Belmonte R, Muniesa JM. Effectiveness of an interactive virtual telerehabilitation system in patients after total knee arthoplasty: a randomized controlled trial. J Rehabil Med. 2013 Apr;45(4):392-6. doi: 10.2340/16501977-1119.
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 (Faktiske)
1. marts 2010
Primær færdiggørelse (Faktiske)
15. december 2011
Studieafslutning (Faktiske)
15. december 2011
Datoer for studieregistrering
Først indsendt
25. maj 2021
Først indsendt, der opfyldte QC-kriterier
8. juni 2021
Først opslået (Faktiske)
11. juni 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. juni 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juni 2021
Sidst verificeret
1. juni 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2/11/2006
Plan for individuelle deltagerdata (IPD)
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