Clinical trial NCT04686071: The Efficiency of the PNF Method
Official title: The Efficiency of the PNF Method in Assessing Functional Performance in Early Stage Patients Following Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthroplasty
Keywords: gonarthrosis, knee replacement, osteoarthritis, PNF method
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 96
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* the total knee arthroplasty due to pain caused by advanced knee osteoarthritis.

Exclusion Criteria:

* stroke

Primary outcomes:
measure: muscle strength test
timeFrame: baseline
measure: muscle strength test
timeFrame: at 10 days
measure: range of motiondigital inclinometer
timeFrame: baseline,
measure: range of motiondigital inclinometer
timeFrame: at 10 days
measure: circuits measurement (centimeter)
timeFrame: baseline, at 10 days
measure: Staffelstein Score
timeFrame: baseline,
measure: Lequesne Index
timeFrame: at 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Krakowskie Centrum Rehabilitacji i Ortopedii
state: Małopolska
city: Krakow
country: Poland
facility: Tomasz Maicki
Study officials:
References:
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citation: Davila 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.
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