Knee OsteoarthritisNCT05920590
The Effect of Proprioceptive Neuromuscular Facilitation and Tendon Vibration After Total Knee Arthroplasty
A study testing PNF and PNF plus Tendon Vibration in people with Knee Osteoarthritis and Total Knee Arthroplastry, run by International Hellenic University at 1 site in Greece.
Trial summary
Knee osteoarthritis is a degenerative joint disease characterized by the destruction and progressive loss of articular cartilage. In an advanced stage of the disease, the patient undergoes a total knee joint replacement with an artificial joint (total arthroplasty). Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Knee Osteoarthritis, Total Knee Arthroplastry
- What is being tested?
- PNF and PNF plus Tendon Vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- 1 Apr 2023to 15 May 2024
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age over 65 years
- Unilateral primary total knee arthroplasty
- Body mass index less than 30
- Active knee flexion range of motion of at least 90° two weeks after surgery
- Written consent to participate in the research
Who cannot join
- Non-ambulatory patients with knee osteoarthritis
- Infections and other surgical complications following the procedure that result in prolonged hospitalization
- Neurodegenerative disease (e.g., Parkinson's)
- Cognitive deficits - dementia (Mini Mental State Exam Test score < 23)
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Physiotherapy, Faculty of Health Sciences International Hellenic Universit
Thessaloniki, Sindos Thessaloníki, 57400
About this study
Official title: The Effect of Proprioceptive Neuromuscular Facilitation and Tendon Vibration After Total Knee Arthroplasty: A Randomized Clinical Trial
Knee osteoarthritis is a degenerative joint disease characterized by the destruction and progressive loss of articular cartilage. In an advanced stage of the disease, the patient undergoes a total knee joint replacement with an artificial joint (total arthroplasty). The aim of this clinical study is to investigate the effect of combining a therapeutic exercise program based on Proprioceptive Neuromuscular Facilitation (PNF) and tendon vibration in older adult patients after total knee arthroplasty (TKA). Ninety (90) adults over 65 years of age who will undergo TKA due to knee osteoarthritis will be divided into three groups of 30 people each (two intervention and one control). The participants in the first group will follow a therapeutic exercise protocol based on the PNF technique for six weeks. The participants in the second intervention group will follow the same therapeutic exercise program based on PNF, and at the same time, tendon vibration will be applied on the common insertion tendon of the rectus femoris and vastus medialis for the same period. Finally, the participants in the third group (control group) will receive instructions for performing exercises at home via a leaflet without receiving any additional treatment. The subjective perception of pain with the Numeric Pain Rating Scale (NPRS), active range of motion (AROM) of knee flexion with a goniometer, functional ability with the Knee Injury and Osteoarthritis Outcome Score (KOOS), quality of life with the Western Ontario and McMaster Universities Arthritis Index (WOMAC), balance using the Timed Up and Go (TUG) test and Berg Balance Scale (BBS), center of mass displacement with a force platform, and knee proprioception through the calculation of joint position sense using the joint repositioning test will be assessed at the beginning of the intervention (4 weeks post-surgery), at the 6th week, and six months post-intervention. For the statistical analysis of the results, a two-factor analysis of variance with repeated measurements will be applied, with the statistical significance level set at p < .05.
Read the detailed description
Background: Knee osteoarthritis is a degenerative joint disease characterized by destruction and progressive loss of articular cartilage. It occurs more often in older adults and is accompanied by pain, stiffness and swelling of the knee joint, difficulty in walking, and a decrease in the functioning of the patient. In an advanced stage of the disease, the patient undergoes a total replacement of the knee joint with an artificial joint (total arthroplasty).
Aim: The aim of this clinical study is to investigate the effect of combining a therapeutic exercise program based on Proprioceptive Neuromuscular Facilitation (PNF) and tendon vibration in older adult patients after total knee arthroplasty (TKA).
Method: Ninety (90) adults over 65 years of age who will undergo TKA due to knee osteoarthritis will be divided into three groups of 30 people each (two intervention and one control). The participants in the first group will follow a therapeutic exercise protocol based on the PNF technique for six weeks. The participants in the second intervention group will follow the same therapeutic exercise program based on PNF, and at the same time, tendon vibration will be applied on the common insertion tendon of the rectus femoris and vastus medialis for the same period. Finally, the participants in the third group (control group) will receive instructions for performing exercises at home via a leaflet without receiving any additional treatment. The subjective perception of pain with the Numeric Pain Rating Scale (NPRS), active range of motion (AROM) of knee flexion with a goniometer, functional ability with the Knee Injury and Osteoarthritis Outcome Score (KOOS), quality of life with the Western Ontario and McMaster Universities Arthritis Index (WOMAC), balance using the Timed Up and Go (TUG) test and Berg Balance Scale (BBS), center of mass displacement with a force platform, and knee proprioception through the calculation of joint position sense using the joint repositioning test will be assessed at the beginning of the intervention (4 weeks post-surgery), at the 6th week, and six months post-intervention. For the statistical analysis of the results, a two-factor analysis of variance with repeated measurements will be applied, with the statistical significance level set at p < .05.
Expected results: It is known that older adults with TKA present deficits in balance and knee proprioception due to the long-term functional limitations caused by the symptoms of the disease (difficulty and pain during standing and movement, impaired gait patterns). These deficits persist even after TKA, making older adults more vulnerable to falls and future injuries. Both PNF and tendon vibration are effective therapeutic approaches for proprioception training in older adults. The investigators believe that the inclusion of tendon vibration in the PNF-based therapeutic exercise program will further increase the balance and proprioceptive ability of older adults, while at the same time accelerating their recovery process. Additionally, the effectiveness of an exercise program based on PNF has not been sufficiently studied.
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplastry
- Being tested
- PNF, PNF plus Tendon Vibration, Control
- Keywords
- Knee Osteoarthritis, Total knee arthroplasty, Proprioceptive Neuromuscular Facilitation, Focal Tendon Vibration, Physiotherapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNFOther
The protocol will be individualized and will last 45 minutes. The following techniques will be applied:
- Application of the "hold - relax" technique to increase the range of motion of knee flexion.
- Rhythmic initiation with the application of diagonal trunk and lower limb shapes.
- Application of stabilizing reversals from a sitting and standing position.
- Application of dynamic reversals from a standing position.
- Rhythmic stabilization.
- Combination of isotonics.
- Gait retraining.
PNF plus Tendon VibrationOther
Participants in this group will be given the same exercise program as Group 1 combined with the application of tendon vibration. Tendon vibration will be applied on both quadriceps' tendons in three weekly sessions (not on the same day as the exercise program). To implement the protocol, 100 Hz frequency mechanical stimulation will be applied.
ControlOther
Participants in this group will be given an exercise leaflet for home-based exercises and will be instructed to perform these exercises three times a week for the same period as the other two groups (6 weeks). They will also be given recommendations to maintain and increase their physical activity.
| Study group | Role | What they receive |
|---|---|---|
| PNF Group | Experimental | Participants allocated to this group will receive 18 sessions of therapeutic exercise program based on the PNF concept (Bello et al. 2011). Receives: Other: PNF |
| PNF and Tendon Vibration Group | Experimental | Participants allocated to this group will receive the same PNF protocol with Group 1 in combination with the application of tendon vibration. Receives: Other: PNF plus Tendon Vibration |
| Control | Active comparator | Participants allocated to this group will be given an exercise leaflet for home-based exercises Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in neck pain intensity with Numeric Pain Rating Scale (NPRS)
This tool is an eleven-point pain scale numbered from zero to 10. The left end of the scale corresponds to zero and is marked as "No pain", whereas the right end corresponds to 10 and is marked as "Maximum pain". Consequently, a higher value indicates more intense pain (Childs et al, 2005). The examinee is asked to choose an integer that best reflects the intensity of their pain. The NPRS is widely used to measure pain in both clinical practice and research, showing high test-retest reliability and high conceptual construct validity.
Measured: pre-treatment, week 6, 6-month follow-up
Changes in active Range of Motion (active ROM) of the knee joint flexion
Active range of knee flexion will be assessed with a long arm goniometer. The measurement will be performed with the subject supine on the examination bed based on the instructions by Hancock et al. (2018), according to whom, measurement with a long arm goniometer shows very high reliability. Three consecutive bends will be requested from the examinee and the highest measured value will be recorded.
Measured: pre-treatment, week 6, 6-month follow-up
3. Changes in functional capacity with the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
The KOOS questionnaire is a self-report tool for assessing functional limitations related to knee injuries or osteoarthritis (Roos et al., 1998). It is used in both research to assess functional ability and in clinical practice. The questionnaire includes 42 questions divided into five subscales: knee pain (KOOS pain), other knee symptoms (KOOS symptoms), functional limitations (KOOS ADL), ability to participate in sports or leisure activities (KOOS Sport/Rec), and quality of life (KOOS QOL). A five-point Likert scale from 0 (No problems) to 4 (Extreme problems) is used to score the questionnaire. Each of the KOOS subscales is scored separately, representing different aspects of the functional limitations experienced by the patient. The score for each subscale is converted to a 100-point scale, where a higher score indicates fewer functional limitations.
Measured: pre-treatment, week 6, 6-month follow-up
Changes in quality of life with Western Ontario and McMaster Universities Arthritis (WOMAC) index
The WOMAC index is widely used in the assessment of the quality of life of people with osteoarthritis of the hip and knee (Salafi et al. 2005). It is a self-report questionnaire consisting of 24 questions classified into three subscales: Pain, knee joint stiffness and functional ability in everyday skills.Test questions are scored on a scale of 0 to 4. Scores for each subscale are summed, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for functional ability. A sum of the scores for all three subscales gives a total WOMAC score. The higher the score, the less functional the joint.The internal consistency of the subcategories of the Greek WOMAC version ranges from high (0.804) to excellent (0.956), while the intra-class correlation coefficients for test-retest reliability have been characterized as excellent (ranging between 0.91 - 0.95) (Papathanasiou et al. 2015).
Measured: pre-treatment, week 6, 6-month follow-up
Changes in Timed Up and Go test
It is a simple test used to assess a person's mobility. It requires both static and dynamic balance and is a valid and reliable indicator of the functional ability of an individual (Podsiadlo \& Richardson, 1991). The participant starts in a seated position. They then stand up following the instructions of the therapist, walk three meters, turn around, walk back to the chair and sit down. The examiner tracks time using a stopwatch. Time is calculated in seconds. A higher score indicates lower functional ability of the participant. The TUG shows high reliability indices in older adults both in measurements by different examiners and in measurements by the same examiner at different times (Cameron and Monroe, 2007).
Measured: pre-treatment, week 6, 6-month follow-up
Changes in Berg Balance scale Test
The Berg Balance Scale is a tool proposed by Berg (Berg et al., 1989; Berg et al., 1992) for assessing balance in the elderly. The test involves the execution of 14 tests of gradual increasing difficulty where in each one, the subject is asked to maintain a given position for a specific time or conduct specific tasks. Each of the 14 tests on the list is graded according to the balancing ability of the examinee from 0 to 4 points (with 0 indicating low balance ability, while 4 indicates high balance ability). According to Berg et al. (1992), a score of 56 indicates functional balance, whereas a score lower than 45 indicates notable balance deficits that have been related to increased fall risk. Studies have shown high intra-rater and inter-rater reliability in the elderly populations with intraclass correlation (ICC) ranging from .98 to .88 (Berg et al. 1992) and high content validity (Telenius et al., 2015).
Measured: pre-treatment, week: 3, 6, 6-month follow-up
Changes of center of mass (COM) displacement
Changes in COM displacement will be recorded using static posturography based on the protocol of Brech et al. (2022). Participants will remain barefoot and static for one minute while standing at ease on the force platform with feet shoulder-width apart, gazing at a target placed 2 meters away. Three attempts will be performed with one-minute intervals in between. The same procedure will be repeated with eyes closed. Parameters for measuring static balance under both conditions (eyes open and eyes closed) will include the root mean square of the displacement from the center of pressure (COP) in the mediolateral and anteroposterior directions. Additionally, the maximum range of COP displacement (sum of maximum and minimum displacement/amplitude) in these directions, and the mean velocity from the total COP displacement in all directions will be considered. For calculating the COP displacement area, values representing 95% of the total displacement ellipse will be used.
Measured: pre-treatment, week 6, 6-month follow-up
Chances in knee joint position sense
Joint position sense will be calculated using the repositioning knee joint test according to the protocol of Relph and Herrington (2015). The joint position sense will be evaluated at two angles: 30° and 60°, with the knee moving from full extension (180°) to 90° flexion and vice versa. For the target angles, the participant will be required to replicate the specified angles.
Measured: pre-treatment, week 6, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start1 Apr 2023
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Model description
- In this study, 90 patients with knee osteoarthritis scheduled for unilateral total knee arthroplasty will participate. Each will follow a 4-week physiotherapy program immediately after surgery, according to the latest guidelines. The program will start on the second postoperative day in the hospital and continue with home visits after discharge. After the initial 4-week period, participants will be randomly assigned to one of three groups. The first group will follow a six-week PNF exercise protocol (PNF group). The second group will follow the same PNF regimen with added targeted vibration therapy on the tendon of the vastus medialis and rectus femoris (PNF + Tendon Vibration group). The third group (control group) will receive instructions and an exercise leaflet for home practice without additional treatment. The intervention will last six weeks, starting four weeks post-surgery, with measurements at baseline, at the 6th week, and at six months post-intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Hellenic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Lytras, International Hellenic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920590
- Sponsor's protocol ID
- EC-09/2023
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2023
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Proprioceptive Neuromuscular Facilitation and Tendon Vibration After Total Knee Arthroplasty: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05920590
- Acronym / sponsor ID
- EC-09/2023
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplastry
- Keywords
- Knee Osteoarthritis, Total knee arthroplasty, Proprioceptive Neuromuscular Facilitation, Focal Tendon Vibration, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- International Hellenic UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 27 Jun 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.
Knee osteoarthritis is a degenerative joint disease characterized by the destruction and progressive loss of articular cartilage. In an advanced stage of the disease, the patient undergoes a total knee joint replacement with an artificial joint (total arthroplasty). The aim of this clinical study is to investigate the effect of combining a therapeutic exercise program based on Proprioceptive Neuromuscular Facilitation (PNF) and tendon vibration in older adult patients after total knee arthroplasty (TKA). Ninety (90) adults over 65 years of age who will undergo TKA due to knee osteoarthritis will be divided into three groups of 30 people each (two intervention and one control). The participants in the first group will follow a therapeutic exercise protocol based on the PNF technique for six weeks. The participants in the second intervention group will follow the same therapeutic exercise program based on PNF, and at the same time, tendon vibration will be applied on the common insertion tendon of the rectus femoris and vastus medialis for the same period. Finally, the participants in the third group (control group) will receive instructions for performing exercises at home via a leaflet without receiving any additional treatment. The subjective perception of pain with the Numeric Pain Rating Scale (NPRS), active range of motion (AROM) of knee flexion with a goniometer, functional ability with the Knee Injury and Osteoarthritis Outcome Score (KOOS), quality of life with the Western Ontario and McMaster Universities Arthritis Index (WOMAC), balance using the Timed Up and Go (TUG) test and Berg Balance Scale (BBS), center of mass displacement with a force platform, and knee proprioception through the calculation of joint position sense using the joint repositioning test will be assessed at the beginning of the intervention (4 weeks post-surgery), at the 6th week, and six months post-intervention. For the statistical analysis of the results, a two-factor analysis of variance with repeated measurements will be applied, with the statistical significance level set at p < .05.
Detailed description
Background: Knee osteoarthritis is a degenerative joint disease characterized by destruction and progressive loss of articular cartilage. It occurs more often in older adults and is accompanied by pain, stiffness and swelling of the knee joint, difficulty in walking, and a decrease in the functioning of the patient. In an advanced stage of the disease, the patient undergoes a total replacement of the knee joint with an artificial joint (total arthroplasty).
Aim: The aim of this clinical study is to investigate the effect of combining a therapeutic exercise program based on Proprioceptive Neuromuscular Facilitation (PNF) and tendon vibration in older adult patients after total knee arthroplasty (TKA).
Method: Ninety (90) adults over 65 years of age who will undergo TKA due to knee osteoarthritis will be divided into three groups of 30 people each (two intervention and one control). The participants in the first group will follow a therapeutic exercise protocol based on the PNF technique for six weeks. The participants in the second intervention group will follow the same therapeutic exercise program based on PNF, and at the same time, tendon vibration will be applied on the common insertion tendon of the rectus femoris and vastus medialis for the same period. Finally, the participants in the third group (control group) will receive instructions for performing exercises at home via a leaflet without receiving any additional treatment. The subjective perception of pain with the Numeric Pain Rating Scale (NPRS), active range of motion (AROM) of knee flexion with a goniometer, functional ability with the Knee Injury and Osteoarthritis Outcome Score (KOOS), quality of life with the Western Ontario and McMaster Universities Arthritis Index (WOMAC), balance using the Timed Up and Go (TUG) test and Berg Balance Scale (BBS), center of mass displacement with a force platform, and knee proprioception through the calculation of joint position sense using the joint repositioning test will be assessed at the beginning of the intervention (4 weeks post-surgery), at the 6th week, and six months post-intervention. For the statistical analysis of the results, a two-factor analysis of variance with repeated measurements will be applied, with the statistical significance level set at p < .05.
Expected results: It is known that older adults with TKA present deficits in balance and knee proprioception due to the long-term functional limitations caused by the symptoms of the disease (difficulty and pain during standing and movement, impaired gait patterns). These deficits persist even after TKA, making older adults more vulnerable to falls and future injuries. Both PNF and tendon vibration are effective therapeutic approaches for proprioception training in older adults. The investigators believe that the inclusion of tendon vibration in the PNF-based therapeutic exercise program will further increase the balance and proprioceptive ability of older adults, while at the same time accelerating their recovery process. Additionally, the effectiveness of an exercise program based on PNF has not been sufficiently studied.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- In this study, 90 patients with knee osteoarthritis scheduled for unilateral total knee arthroplasty will participate. Each will follow a 4-week physiotherapy program immediately after surgery, according to the latest guidelines. The program will start on the second postoperative day in the hospital and continue with home visits after discharge. After the initial 4-week period, participants will be randomly assigned to one of three groups. The first group will follow a six-week PNF exercise protocol (PNF group). The second group will follow the same PNF regimen with added targeted vibration therapy on the tendon of the vastus medialis and rectus femoris (PNF + Tendon Vibration group). The third group (control group) will receive instructions and an exercise leaflet for home practice without additional treatment. The intervention will last six weeks, starting four weeks post-surgery, with measurements at baseline, at the 6th week, and at six months post-intervention.
| Arm | Type | Receives |
|---|---|---|
| PNF Group | Experimental | Other: PNFParticipants allocated to this group will receive 18 sessions of therapeutic exercise program based on the PNF concept (Bello et al. 2011). |
| PNF and Tendon Vibration Group | Experimental | Other: PNF plus Tendon VibrationParticipants allocated to this group will receive the same PNF protocol with Group 1 in combination with the application of tendon vibration. |
| Control | Active comparator | Other: ControlParticipants allocated to this group will be given an exercise leaflet for home-based exercises |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Age over 65 years
- Unilateral primary total knee arthroplasty
- Body mass index less than 30
- Active knee flexion range of motion of at least 90° two weeks after surgery
- Written consent to participate in the research
Key exclusion criteria (4 listed)
- Non-ambulatory patients with knee osteoarthritis
- Infections and other surgical complications following the procedure that result in prolonged hospitalization
- Neurodegenerative disease (e.g., Parkinson's)
- Cognitive deficits - dementia (Mini Mental State Exam Test score < 23)
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 |
|---|---|---|
| PNFThe protocol will be individualized and will last 45 minutes. The following techniques will be applied: * Application of the "hold - relax" technique to increase the range of motion of knee flexion. * Rhythmic initiation with the application of diagonal trunk and lower limb shapes. * Application of stabilizing reversals from a sitting and standing position. * Application of dynamic reversals from a standing position. * Rhythmic stabilization. * Combination of isotonics. * Gait retraining. | Other | PNF Group |
| PNF plus Tendon VibrationParticipants in this group will be given the same exercise program as Group 1 combined with the application of tendon vibration. Tendon vibration will be applied on both quadriceps' tendons in three weekly sessions (not on the same day as the exercise program). To implement the protocol, 100 Hz frequency mechanical stimulation will be applied. | Other | PNF and Tendon Vibration Group |
| ControlParticipants in this group will be given an exercise leaflet for home-based exercises and will be instructed to perform these exercises three times a week for the same period as the other two groups (6 weeks). They will also be given recommendations to maintain and increase their physical activity. | Other | Control |
Primary outcome
Changes in neck pain intensity with Numeric Pain Rating Scale (NPRS)
Time frame: pre-treatment, week 6, 6-month follow-up
This tool is an eleven-point pain scale numbered from zero to 10. The left end of the scale corresponds to zero and is marked as "No pain", whereas the right end corresponds to 10 and is marked as "Maximum pain". Consequently, a higher value indicates more intense pain (Childs et al, 2005). The examinee is asked to choose an integer that best reflects the intensity of their pain. The NPRS is widely used to measure pain in both clinical practice and research, showing high test-retest reliability and high conceptual construct validity.
Changes in active Range of Motion (active ROM) of the knee joint flexion
Time frame: pre-treatment, week 6, 6-month follow-up
Active range of knee flexion will be assessed with a long arm goniometer. The measurement will be performed with the subject supine on the examination bed based on the instructions by Hancock et al. (2018), according to whom, measurement with a long arm goniometer shows very high reliability. Three consecutive bends will be requested from the examinee and the highest measured value will be recorded.
3. Changes in functional capacity with the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Time frame: pre-treatment, week 6, 6-month follow-up
The KOOS questionnaire is a self-report tool for assessing functional limitations related to knee injuries or osteoarthritis (Roos et al., 1998). It is used in both research to assess functional ability and in clinical practice. The questionnaire includes 42 questions divided into five subscales: knee pain (KOOS pain), other knee symptoms (KOOS symptoms), functional limitations (KOOS ADL), ability to participate in sports or leisure activities (KOOS Sport/Rec), and quality of life (KOOS QOL). A five-point Likert scale from 0 (No problems) to 4 (Extreme problems) is used to score the questionnaire. Each of the KOOS subscales is scored separately, representing different aspects of the functional limitations experienced by the patient. The score for each subscale is converted to a 100-point scale, where a higher score indicates fewer functional limitations.
Changes in quality of life with Western Ontario and McMaster Universities Arthritis (WOMAC) index
Time frame: pre-treatment, week 6, 6-month follow-up
The WOMAC index is widely used in the assessment of the quality of life of people with osteoarthritis of the hip and knee (Salafi et al. 2005). It is a self-report questionnaire consisting of 24 questions classified into three subscales: Pain, knee joint stiffness and functional ability in everyday skills.Test questions are scored on a scale of 0 to 4. Scores for each subscale are summed, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for functional ability. A sum of the scores for all three subscales gives a total WOMAC score. The higher the score, the less functional the joint.The internal consistency of the subcategories of the Greek WOMAC version ranges from high (0.804) to excellent (0.956), while the intra-class correlation coefficients for test-retest reliability have been characterized as excellent (ranging between 0.91 - 0.95) (Papathanasiou et al. 2015).
Changes in Timed Up and Go test
Time frame: pre-treatment, week 6, 6-month follow-up
It is a simple test used to assess a person's mobility. It requires both static and dynamic balance and is a valid and reliable indicator of the functional ability of an individual (Podsiadlo \& Richardson, 1991). The participant starts in a seated position. They then stand up following the instructions of the therapist, walk three meters, turn around, walk back to the chair and sit down. The examiner tracks time using a stopwatch. Time is calculated in seconds. A higher score indicates lower functional ability of the participant. The TUG shows high reliability indices in older adults both in measurements by different examiners and in measurements by the same examiner at different times (Cameron and Monroe, 2007).
Changes in Berg Balance scale Test
Time frame: pre-treatment, week: 3, 6, 6-month follow-up
The Berg Balance Scale is a tool proposed by Berg (Berg et al., 1989; Berg et al., 1992) for assessing balance in the elderly. The test involves the execution of 14 tests of gradual increasing difficulty where in each one, the subject is asked to maintain a given position for a specific time or conduct specific tasks. Each of the 14 tests on the list is graded according to the balancing ability of the examinee from 0 to 4 points (with 0 indicating low balance ability, while 4 indicates high balance ability). According to Berg et al. (1992), a score of 56 indicates functional balance, whereas a score lower than 45 indicates notable balance deficits that have been related to increased fall risk. Studies have shown high intra-rater and inter-rater reliability in the elderly populations with intraclass correlation (ICC) ranging from .98 to .88 (Berg et al. 1992) and high content validity (Telenius et al., 2015).
Changes of center of mass (COM) displacement
Time frame: pre-treatment, week 6, 6-month follow-up
Changes in COM displacement will be recorded using static posturography based on the protocol of Brech et al. (2022). Participants will remain barefoot and static for one minute while standing at ease on the force platform with feet shoulder-width apart, gazing at a target placed 2 meters away. Three attempts will be performed with one-minute intervals in between. The same procedure will be repeated with eyes closed. Parameters for measuring static balance under both conditions (eyes open and eyes closed) will include the root mean square of the displacement from the center of pressure (COP) in the mediolateral and anteroposterior directions. Additionally, the maximum range of COP displacement (sum of maximum and minimum displacement/amplitude) in these directions, and the mean velocity from the total COP displacement in all directions will be considered. For calculating the COP displacement area, values representing 95% of the total displacement ellipse will be used.
Chances in knee joint position sense
Time frame: pre-treatment, week 6, 6-month follow-up
Joint position sense will be calculated using the repositioning knee joint test according to the protocol of Relph and Herrington (2015). The joint position sense will be evaluated at two angles: 30° and 60°, with the knee moving from full extension (180°) to 90° flexion and vice versa. For the target angles, the participant will be required to replicate the specified angles.
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 4 Jun 2024.
- Individual participant dataSharing planned: No
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Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF and PNF plus Tendon Vibration in people with Knee Osteoarthritis and Total Knee Arthroplastry, run by International Hellenic University at 1 site in Greece.
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 4 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 4 Jun 2024. 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 Greece. 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?
Changes in neck pain intensity with Numeric Pain Rating Scale (NPRS) (time frame: pre-treatment, week 6, 6-month follow-up). 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 4 Jun 2024.