Efficacy of Proprioceptive Neuromuscular Facilitation Exercise Programme in Patients With Total Knee Arthroplasty

Knee Arthroplasty Clinical Trial

Official title:

Efficacy of Proprioceptive Neuromuscular Facilitation Exercise Programme Versus Usual Care in Patients With Total Knee Arthroplasty: A Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05999864
• Other study ID #: FethiyeTDAPNF
• Status: Recruiting
• Phase: N/A
• Start date: June 8, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: March 2024
• Source: Mugla Sitki Koçman University
• Contact: Fatih Özden, PhD
• Phone: 543 433 4593
• Email: fatihozden[@]mu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: January 1, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroplasty

Intervention

Other:
• Rehabilitation
Proprioceptive neuromuscular facilitation exercise will be given to the study group as previously described (Gstoettner et al., 2011). These applications will be applied to the patients for 8 weeks, 2 days a week in the clinical environment after the initial evaluation. In addition, both groups will be told that they can contact the researcher when requested.

Locations

Country	Name	City	State
Turkey	Fethiye State Hospital	Mugla	Fethiye

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	On a 10 cm straight line or numeric scale, the patient is asked to mark the pain they feel (0: no pain, 10: excruciating pain).	Change from Baseline VAS at 8 weeks
Primary	Western-Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	Functionality level in the patient group with knee OA was measured using WOMAC. WOMAC consists of 3 main headings: pain intensity, stiffness and physical function. The individuals included in the study are asked to score each item between 0 (no pain, stiffness, difficulty) and 5 (very severe pain, stiffness, difficulty). The total score ranges from 0 (no disability) to 96 (complete disability).	Change from Baseline WOMAC at 8 weeks
Primary	Knee Joint Proprioception Measurement	The inclinometer is placed distal to the tibial tuberosity. In full knee extension, the patient is asked to perform a single leg squat with eyes closed or unable to see the leg being tested. He/she is allowed to support with his/her hands to prevent loss of balance. When the knee flexion angle of 30° is reached, the patient is asked to stop and stay at this point for 5 seconds. Then return to full knee extension. This movement is repeated 3 times. This time, without any stop command, the patient is asked to reach the same 30° knee flexion angle as in the previous exercises. This application is also repeated 3 times. The "absolute angle difference", which is the difference between the targeted angle in each repetition and the angle realized by the patient, is recorded. The arithmetic mean of the 3 repetitions' absolute angle difference is recorded as the result data.	Change from Baseline Knee Joint Proprioception Measurement at 8 weeks
Primary	Modified Four Square Step Test (mFSST)	A suitable background is divided into four identical squares with a "+" shaped line using tape. The squares are numbered with numbers between 1-4 in a clockwise direction and this sequence is explained to the participant. The patient steps from the starting point to squares 1,2,3 and 4 in a way that the direction remains the same and without stepping on the lines. The test is terminated when the last foot contact is interrupted at square 4. The time elapsed during the main measurement is recorded with a stopwatch.	Change from Baseline mFSST at 8 weeks
Primary	Figure 8 Walking Test (F8WT)	Participants are instructed to stand at the midpoint between two cones (1.52 m apart) and look at one of the cones. Participants are asked to walk in a circle of 8 around the cones at a comfortable speed and direction of their choice. The stopwatch is stopped while returning to the starting point. The elapsed time and the number of steps taken are recorded.	Change from Baseline F8WT at 8 weeks
Primary	Berg Balance Scale (BBS)	The 14 items in the scale assess static sitting and standing balance as well as expected balance during activities. Scoring is done on a 5-point scale that takes into account whether the patient can perform the task safely and independently and is usually based on a specific time interval. Normal performances are rated from 0 (unable to perform) to 4 points (normal performance). Scores on individual items are summed for a total score, with a maximum score of 56 points.	Change from Baseline BBS at 8 weeks
Primary	Activity Specific Balance Confidence Scale (ABC)	This scale includes 16 tasks related to indoor and outdoor activities of daily living to measure balance confidence in older people with various levels of function. Scores for each question range from 0% (no confidence) to 100% (full confidence). Higher scores indicate greater confidence.	Change from Baseline ABC at 8 weeks
Primary	Tampa Scale for Kinesiophobia (TSK)	The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.	Change from Baseline TSK at 8 weeks