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

Primary Purpose

Knee Arthroplasty

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rehabilitation
Sponsored by
Muğla Sıtkı Koçman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthroplasty

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fethiye State HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

In addition to the program given to the control group, 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.

The control group will receive the usual post-operative care of stretching lower extremity strengthening balance exercises activities of daily living recommendations.

Outcomes

Primary Outcome Measures

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).
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).
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2023
Last Updated
August 14, 2023
Sponsor
Muğla Sıtkı Koçman University
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1. Study Identification

Unique Protocol Identification Number
NCT05999864
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2023 (Actual)
Primary Completion Date
March 8, 2024 (Anticipated)
Study Completion Date
June 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
In addition to the program given to the control group, 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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
The control group will receive the usual post-operative care of stretching lower extremity strengthening balance exercises activities of daily living recommendations.
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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).
Time Frame
Change from Baseline VAS at 8 weeks
Title
Western-Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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).
Time Frame
Change from Baseline WOMAC at 8 weeks
Title
Knee Joint Proprioception Measurement
Description
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.
Time Frame
Change from Baseline Knee Joint Proprioception Measurement at 8 weeks
Title
Modified Four Square Step Test (mFSST)
Description
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.
Time Frame
Change from Baseline mFSST at 8 weeks
Title
Figure 8 Walking Test (F8WT)
Description
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.
Time Frame
Change from Baseline F8WT at 8 weeks
Title
Berg Balance Scale (BBS)
Description
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.
Time Frame
Change from Baseline BBS at 8 weeks
Title
Activity Specific Balance Confidence Scale (ABC)
Description
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.
Time Frame
Change from Baseline ABC at 8 weeks
Title
Tampa Scale for Kinesiophobia (TSK)
Description
The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
Time Frame
Change from Baseline TSK at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatih Özden, PhD
Phone
543 433 4593
Ext
+90
Email
fatihozden@mu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatih Özden, PhD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
İsmet Tümtürk, MSc
Organizational Affiliation
Süleyman Demirel University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
İsmail Uysal, PhD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fatih Özyer, MD
Organizational Affiliation
Fethiye State Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nazan Tuğay, PhD
Organizational Affiliation
Sanko University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fethiye State Hospital
City
Muğla
State/Province
Fethiye
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fatih Özyer, MD
Phone
532 271 5411
Ext
+90
Email
fatihozyer@yahoo.com
First Name & Middle Initial & Last Name & Degree
Fatih Özden, PhD
First Name & Middle Initial & Last Name & Degree
İsmet Tümtürk, MSc
First Name & Middle Initial & Last Name & Degree
Fatih Özyer, MD
First Name & Middle Initial & Last Name & Degree
İsmail Uysal, PhD
First Name & Middle Initial & Last Name & Degree
Nazan Tuğay, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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