Knee ArthroplastyNCT05999864
Efficacy of Proprioceptive Neuromuscular Facilitation Exercise Programme in Patients With Total Knee Arthroplasty
A study testing Rehabilitation in people with Knee Arthroplasty, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Jun 2023to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Have any other orthopedic or neurological problem that may affect treatment and assessments
- Situations that prevent communication
- Lack of cooperation during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Proprioceptive Neuromuscular Facilitation Exercise Programme Versus Usual Care in Patients With Total Knee Arthroplasty: A Randomised Controlled Trial
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.
- Conditions
- Knee Arthroplasty
- Being tested
- Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: Rehabilitation |
| Control Group | Active comparator | The control group will receive the usual post-operative care of stretching lower extremity strengthening balance exercises activities of daily living recommendations. Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Change from Baseline VAS at 8 weeks
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).
Measured: Change from Baseline WOMAC at 8 weeks
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.
Measured: Change from Baseline Knee Joint Proprioception Measurement at 8 weeks
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.
Measured: Change from Baseline mFSST at 8 weeks
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.
Measured: Change from Baseline F8WT at 8 weeks
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.
Measured: Change from Baseline BBS at 8 weeks
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.
Measured: Change from Baseline ABC at 8 weeks
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.
Measured: Change from Baseline TSK at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start8 Jun 2023
- Primary completion30 Sep 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Ozden, Muğla Sıtkı Koçman University
- Investigators
- Fatih Özden, PhD, Study director, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999864
- Sponsor's protocol ID
- TDAPNF
- Status last verified
- Dec 2025
- First submitted
- 14 Aug 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Proprioceptive Neuromuscular Facilitation Exercise Programme Versus Usual Care in Patients With Total Knee Arthroplasty: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05999864
- Acronym / sponsor ID
- TDAPNF
- Conditions
- Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: RehabilitationIn 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. |
| Control Group | Active comparator | Other: RehabilitationThe control group will receive the usual post-operative care of stretching lower extremity strengthening balance exercises activities of daily living recommendations. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RehabilitationProprioceptive 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. | Other | Control Group, Intervention Group |
Primary outcome
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).
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).
Knee Joint Proprioception Measurement
Time frame: Change from Baseline Knee Joint Proprioception Measurement at 8 weeks
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)
Time frame: Change from Baseline mFSST at 8 weeks
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)
Time frame: Change from Baseline F8WT at 8 weeks
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)
Time frame: Change from Baseline BBS at 8 weeks
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)
Time frame: Change from Baseline ABC at 8 weeks
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)
Time frame: Change from Baseline TSK at 8 weeks
The questionnaire is a 17-item scale developed to measure fear of movement/reinjury. The normal score range is between 17 and 68.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatih Özden, PhD study director
Muğla Sıtkı Koçman University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Knee Arthroplasty, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Change from Baseline VAS at 8 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.