Clinical trial NCT05999864: Efficacy of Proprioceptive Neuromuscular Facilitation Exercise Programme in Patients With Total Knee Arthroplasty
Official title: Efficacy of Proprioceptive Neuromuscular Facilitation Exercise Programme Versus Usual Care in Patients With Total Knee Arthroplasty: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Arthroplasty
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 32
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was planned to investigate the effectiveness of usual care and proprioceptive neuromuscular facilitation exercise program in patients undergoing total knee arthroplasty surgery. It is aimed to evaluate pain intensity, disability level, proprioception, kinesiophobia, balance, range of motion and functional status of the patients. The study will be conducted with volunteer patients who are followed up by the Orthopedics and Traumatology outpatient clinic of Fethiye State Hospital and who have undergone total knee arthroplasty surgery. The evaluations will be performed in the Orthopedics and Traumatology outpatient clinic of Fethiye State Hospital. It is aimed to evaluate at least 32 patients for the study. The first evaluation will be performed 6 weeks post-operatively and the second evaluation will be performed 2 months after the treatment.


Eligibility criteria: Inclusion Criteria:

* Having undergone unilateral total knee arthroplasty surgery and being 6 weeks postoperative
* Participate in all necessary follow-up assessments
* 60 years of age or older
* Understand simple commands
* Signing the consent form

Exclusion Criteria:

* A previous history of total knee arthroplasty
* Presence of revision surgery
* Presence of severe osteoarthritis in the contralateral knee
* Severe acute metabolic neuromuscular and cardiovascular diseases
* Extreme obesity (bki\>35)
* Presence of malignancy
* Have any other orthopedic or neurological problem that may affect treatment and assessments
* Situations that prevent communication
* Lack of cooperation during the study

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Change from Baseline VAS at 8 weeks
measure: Western-Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Change from Baseline WOMAC at 8 weeks
measure: Knee Joint Proprioception Measurement
timeFrame: Change from Baseline Knee Joint Proprioception Measurement at 8 weeks
measure: Modified Four Square Step Test (mFSST)
timeFrame: Change from Baseline mFSST at 8 weeks
measure: Figure 8 Walking Test (F8WT)
timeFrame: Change from Baseline F8WT at 8 weeks
measure: Berg Balance Scale (BBS)
timeFrame: Change from Baseline BBS at 8 weeks
measure: Activity Specific Balance Confidence Scale (ABC)
timeFrame: Change from Baseline ABC at 8 weeks
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: Change from Baseline TSK at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Fethiye State Hospital
state: Fethiye
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Fatih Özden, PhD
role: STUDY_DIRECTOR
affiliation: Süleyman Demirel University
name: İsmet Tümtürk, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Muğla Sıtkı Koçman University
name: İsmail Uysal, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fethiye State Hospital
name: Fatih Özyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sanko University
name: Nazan Tuğay, PhD
role: PRINCIPAL_INVESTIGATOR
References: