- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06009432
Efficacy of Proprioceptive Neuromuscular Facilitation Exercise Program in Total Hip Arthroplasty
December 7, 2025 updated by: Fatih Ozden, Muğla Sıtkı Koçman University
Efficacy of Proprioceptive Neuromuscular Facilitation Exercise Program Versus Usual Care in Patients With Total Hip Arthroplasty: A Randomized Controlled Trial
This study was planned to investigate the effectiveness of usual care and additional proprioceptive neuromuscular facilitation exercise program in patients undergoing total hip arthroplasty surgery.
It is aimed to evaluate pain intensity, disability level, proprioception, kinesiophobia, balance 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 hip 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 42 patients for the study.
The first evaluation will be performed 6 weeks post-operatively and the second evaluation will be performed 2 months after treatment.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Muğla, Turkey (Türkiye)
- Muğla
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Having undergone unilateral total hip 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 hip arthroplasty
- Presence of revision surgery
- Presence of severe osteoarthritis in the contralateral hip
- Severe acute metabolic neuromuscular and cardiovascular diseases
- Severe 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
The control group will receive the usual post-operative care of stretching lower extremity strengthening balance exercises activities of daily living recommendations.
|
The control group will receive the usual post-operative care of stretching, lower extremity strengthening, balance exercises, activities of daily living recommendations.
The study group will be given proprioceptive neuromuscular facilitation exercise in addition to the program given to the control group.
|
|
Experimental: Intervention Group
In addition to the program given to the control group, the study group will be given proprioceptive neuromuscular facilitation exercise as previously described (Smedes et.
al., 2021).
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.
The study group will be given proprioceptive neuromuscular facilitation exercise in addition to the program given to the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (VAS)
Time Frame: Change from Baseline VAS at 8 weeks
|
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
|
|
Western-Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: Change from Baseline WOMAC at 8 weeks
|
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
|
|
Five Times Sit to Stand Test (5TSST)
Time Frame: Change from Baseline 5TSST at 8 weeks
|
A chair without armrests, with a 28.5 cm deep seat and backrest and adjustable height is used for the tests.
Subjects start in a seated position, with their arms in the desired position and their backs against the chair backrest.
The following verbal instructions are given: "Please stand up and sit down 5 times as quickly as possible.
Straighten your knees when standing up and lean your back against the backrest when sitting down."
Timing with the digital stopwatch is started manually with the instruction "Start" and stopped when the subject's back touches the backrest after the fifth standing up.
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Change from Baseline 5TSST at 8 weeks
|
|
3 Meter Backward Walk Test (3MBWT)
Time Frame: Change from Baseline 3MBWT at 8 weeks
|
A distance of 3 meters is measured and marked.
Children are asked to walk backwards safely when the signal is given and stop when they reach the marked point.
They are allowed to look behind them if necessary.
Measurements are repeated 3 times and the average time is recorded.
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Change from Baseline 3MBWT at 8 weeks
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One Leg Standing Test (OLST)
Time Frame: Change from Baseline OLST at 8 weeks
|
The subject is tested standing on one leg using the right and left legs respectively.
The test is repeated on a hard surface with eyes open and closed.
The subject is asked to place both hands on the hips and look at a target on the wall at eye level at a distance of 1 meter.
The subject is asked to stand with one leg in a 90 degree flexion position and the other leg in a standing position.
A stopwatch is used to record the time the subject can maintain the test position.
If the subject can hold the position for more than 30 seconds, the test is terminated and the elapsed time is recorded.
|
Change from Baseline OLST at 8 weeks
|
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Fear-Avoidance Beliefs Questionnaire (FABQ)
Time Frame: Change from Baseline FABQ at 8 weeks
|
The FABQ consists of 16 items and is divided into 2 subscales.
The items are scored on a 7-point Likert scale (from strongly disagree to strongly agree).
The score of each subscale is used independently.
Higher scores represent more fear avoidance beliefs.
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Change from Baseline FABQ at 8 weeks
|
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Falls Efficacy Scale International (FES-I)
Time Frame: Change from Baseline FES-I at 8 weeks
|
The FES-I is a self-report questionnaire, providing information on level of concern about falls during activities of daily living.
The questionnaire contains 16 items scored on a four-point scale (1 = not at all concerned to 4 = very concerned) providing a total score ranging from 16 (absence of concern) to 64 (extreme concern).
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Change from Baseline FES-I at 8 weeks
|
|
Hip joint proprioception measurement
Time Frame: Change from Baseline proprioception measurement at 8 weeks
|
Patients were placed in a supine position and blindfolded to eliminate visual cues.
The test started at neutral position (0°) and patient actively fexed the hip toward the fexion target position of 45°, which was indicated by a mechanical obstruction.
After holding that position for 5 s, patient focused and remembered the angle, and brought the joint actively back to the neutral starting position.
Then, patient was asked to actively reproduce the target position without the mechanical obstruction and hold at where he/she felt it was the just position.
Five repetitions were performed for each leg and "absolute angular error" values were obtained from the start and stop angles.
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Change from Baseline proprioception measurement at 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Fatih Özden, PhD, Muğla Sıtkı Koçman University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2024
Primary Completion (Actual)
October 1, 2025
Study Completion (Actual)
December 1, 2025
Study Registration Dates
First Submitted
August 19, 2023
First Submitted That Met QC Criteria
August 19, 2023
First Posted (Actual)
August 24, 2023
Study Record Updates
Last Update Posted (Estimated)
December 15, 2025
Last Update Submitted That Met QC Criteria
December 7, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- kalça artroplasti pnf rkç
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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