- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT04686071
The Efficiency of the PNF Method
The Efficiency of the PNF Method in Assessing Functional Performance in Early Stage Patients Following Knee Arthroplasty
Background: Early rehabilitation following knee arthroplasty is an integral part of medical management which reduces the time of patient's stay at hospital and eliminates the risk of post-operative complications. The absence of consensus on the most efficient post-operative rehabilitation strategy and shortage of practices based on evidence lead to seek new therapeutic solutions. Therefore the goal of this study is to evaluate the efficiency of the PNF method in assessing functional performance in early stage patients following knee arthroplasty Material and methods: The study was conducted among 96 patients (66,34 years ±7,29) who were qualified to total knee arthroplasty. The patients were randomly divided into two groups. In the control group standard rehabilitation protocol was implemented while post-operative treatment in the study group based on PNF method. All the patients were tested on the day of admission to the hospital and after completing a 10-day rehabilitation program. Structural and functional parameters of the operated knee (muscle strength, range of motion, circuit measurements) as well as functional abilities (Staffelstein Score, Lequesne Index) were evaluated.
Key words: gonarthrosis, knee replacement, osteoarthritis, PNF method
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Involution changes of the human body are characteristics of aging. A decrease in physical activity as well as increased life expectancy can be a factor in the development of many pathological changes in the movement system resulting in increase in the number of people with diagnosed osteoarthritis (OA) [1]. Epidemiological studies indicate that osteoarthritis affects up to 40 million people in Europe [2], including 10% of men and 13% of women above 60 years of age with knee degenerative changes [3]. It is estimated that in Poland over 8 million people suffer from osteoarthritis, out of which 25% have gonarthrosis [4]. Osteoarthritis detracts from the quality of life and leads to malfunction and this is therefore necessary to early implement prevention and treatment actions which allow for keeping functional performance and protection against development of destructive changes [5].The study will be conducted in Cracow Rehabilitation and Orthopedics Centre. The study group will be qualified to the total knee arthroplasty due to pain caused by advanced knee osteoarthritis. . The patients will be randomly divided into two groups which differed in the type of a 10-day treatment model used after the operation.
In the control group standard rehabilitation protocol will be used in patients following TKA, which is mainly based on activities in open chains (passive exercises with continuous passive motion (CMP) device, active exercises, isometric, active resistance, patella mobilization, deep tissue massage, verticalization and gait relearning). Treatment in the study group will be conducted with PNF method with a use of indirect training based on irradiation phenomenon. The program included: proprioceptive stimulation of the operated limb, improving trunk stabilization and active control, active foot training, muscle strength facilitation of lower limbs in closed kinematic chain with considering periarticular stabilization within the operated knee joint as well as exercises improving mobility of the operated knee, verticalization and locomotion with emphasis on the stance phase.
In this study, an attempt will be made to analyze treatment effects on parameters assessing function of the knee joint and functional abilities in daily living with a use of a classic rehabilitation protocol and PNF method in patients following TKA. To evaluate efficacy of the therapy all the patients will be tested on the day of admission to the hospital and on the last day of the treatment. Structural and activity parameters of the operated knee joint will be evaluated, such as muscle strength (6-point Lovett scale), range of motion (digital inclinometer) and circuits measurement (centimeter). Circuits were measured on the level of the knee joint articular space, 10 cm (Thigh I) and 20 cm (Thigh II) above the articular space as well as on the level of lower leg (the widest point). Scales based on a subjective evaluation, such as Staffelstein Score and Lequesne Index will be performed to assess functional abilities.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Krakow, Puola
- Tomasz Maicki
-
-
Małopolska
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Krakow, Małopolska, Puola, 30-224
- Krakowskie Centrum Rehabilitacji i Ortopedii
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- the total knee arthroplasty due to pain caused by advanced knee osteoarthritis.
Exclusion Criteria:
- stroke
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
---|---|
Kokeellinen: PNF method
|
Treatment in the study group was conducted with PNF method with a use of indirect training based on irradiation phenomenon.
The program included: proprioceptive stimulation of the operated limb, improving trunk stabilization and active control, active foot training, muscle strength facilitation of lower limbs in closed kinematic chain with considering periarticular stabilization within the operated knee joint as well as exercises improving mobility of the operated knee, verticalization and locomotion with emphasis on the stance phase.
|
Muut: standard rehabilitation
|
In the control group standard rehabilitation protocol was used in patients following TKA, which is mainly based on activities in open chains (passive exercises with continuous passive motion (CMP) device, active exercises, isometric, active resistance, patella mobilization, deep tissue massage, verticalization and gait relearning).
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
muscle strength test
Aikaikkuna: baseline
|
(6-point Lovett scale)
|
baseline
|
muscle strength test
Aikaikkuna: at 10 days
|
(6-point Lovett scale)
|
at 10 days
|
range of motiondigital inclinometer
Aikaikkuna: baseline,
|
baseline,
|
|
range of motiondigital inclinometer
Aikaikkuna: at 10 days
|
at 10 days
|
|
circuits measurement (centimeter)
Aikaikkuna: baseline, at 10 days
|
Circuits were measured on the level of the knee joint articular space, 10 cm (Thigh I) and 20 cm (Thigh II) above the articular space as well as on the level of lower leg (the widest point).
|
baseline, at 10 days
|
Staffelstein Score
Aikaikkuna: baseline,
|
subjective evaluation to assess functional abilities
|
baseline,
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Lequesne Index
Aikaikkuna: at 10 days
|
subjective evaluationto assess functional abilities
|
at 10 days
|
Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.
- Conaghan PG, Kloppenburg M, Schett G, Bijlsma JW; EULAR osteoarthritis ad hoc committee. Osteoarthritis research priorities: a report from a EULAR ad hoc expert committee. Ann Rheum Dis. 2014 Aug;73(8):1442-5. doi: 10.1136/annrheumdis-2013-204660. Epub 2014 Mar 13.
- Zhang Y, Jordan JM. Epidemiology of osteoarthritis. Clin Geriatr Med. 2010 Aug;26(3):355-69. doi: 10.1016/j.cger.2010.03.001. Erratum In: Clin Geriatr Med. 2013 May;29(2):ix.
- Chojnacki M, Kwapisz A, Synder M, Szemraj J. [Osteoarthritis: etiology, risk factors, molecular mechanisms]. Postepy Hig Med Dosw (Online). 2014 Jan 2;68:640-52. doi: 10.5604/17322693.1103551. Review. Polish.
- Jordan KM, Arden NK, Doherty M, Bannwarth B, Bijlsma JW, Dieppe P, Gunther K, Hauselmann H, Herrero-Beaumont G, Kaklamanis P, Lohmander S, Leeb B, Lequesne M, Mazieres B, Martin-Mola E, Pavelka K, Pendleton A, Punzi L, Serni U, Swoboda B, Verbruggen G, Zimmerman-Gorska I, Dougados M; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003 Dec;62(12):1145-55. doi: 10.1136/ard.2003.011742.
- National Clinical Guideline Centre [editorial]. Osteoarhritis: care and management in adults. NICE 2014;177: 1-36
- Dávila Castrodad IM, Recai TM, Abraham MM, Etcheson JI, Mohamed NS, Edalatpour A, Delanois RE. Rehabilitation protocols following total knee arthroplasty: a review of study designs and outcome measures. Ann Transl Med. 2019 Oct;7(Suppl 7):S255. doi: 10.21037/atm.2019.08.15. Review.
- Papalia R, Campi S, Vorini F, Zampogna B, Vasta S, Papalia G, Fossati C, Torre G, Denaro V. The Role of Physical Activity and Rehabilitation Following Hip and Knee Arthroplasty in the Elderly. J Clin Med. 2020 May 9;9(5). pii: E1401. doi: 10.3390/jcm9051401. Review.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muut tutkimustunnusnumerot
- KNEE2018
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-jaon aikakehys
IPD-jaon käyttöoikeuskriteerit
IPD-jakamista tukeva tietotyyppi
- Tutkimuspöytäkirja
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Yhdysvalloissa valmistettu ja sieltä viety tuote
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