Knee OsteoarthritisNCT06331858
The Effect of Adding Instrumented Hip Concentric Abductor Strengthening Exercise in Knee Osteoarthritis
A study testing hip device-assisted concentric abductor strengthening (HDACAS) and knee device-assisted concentric flexor-extensor strengthening (KDACFES) in people with Knee Osteoarthritis and Pain, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effectiveness of adding hip device-assisted concentric abductor strengthening (HDACAS) program to knee device-assisted concentric flexor-extensor strengthening (KDACFES) program on pain, function, physical performance, quality of life and gait parameters in patients with… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Knee Osteoarthritis, Pain, Physical Disability
- What is being tested?
- hip device-assisted concentric abductor strengthening (HDACAS) and knee device-assisted concentric flexor-extensor strengthening (KDACFES)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2023to 29 Mar 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving a diagnosis of knee osteoarthritis according to the ACR criteria and being classified as stage 2-3 according to the Kellgren Lawrence staging
- Having symptomatic unilateral or bilateral knee pain with a VAS (0-10) pain score > 4
- Being able to ambulate independently without orthosis/prosthesis
- Having a body mass index less than 35
Who cannot join
- History of knee and hip surgery
- Presence of lesions, atrophy, or scars in the skin area
- Intra-articular injection to the knee within the last 6 months
- Receiving active physiotherapy, physical therapy, or spa treatment in the last 6 months
- Patients with chronic diseases such as COPD, coronary artery disease
- Those with oxygen saturation levels <95%
Show all 9Show fewer
- Individuals with any pathological condition that may impair normal walking
- Patients with diseases such as vertigo, epilepsy that may pose a risk during physical performance tests
- Patients with contraindications to strength training exercises
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, Kütahya, 43100
About this study
Official title: The Effect of Adding Instrumented Hip Concentric Abductor Strengthening Exercise to Instrumented Knee Flexor-Extensor Concentric Strengthening Exercise on Pain, Function, Physical Performance, and Quality of Life in Knee Osteoarthritis
The aim of this study was to investigate the effectiveness of adding hip device-assisted concentric abductor strengthening (HDACAS) program to knee device-assisted concentric flexor-extensor strengthening (KDACFES) program on pain, function, physical performance, quality of life and gait parameters in patients with knee osteoarthritis (OA).
Read the detailed description
This prospective randomized single-blind controlled study was conducted at Kütahya Health Sciences University (KHSU) Evliya Çelebi Education and Research Hospital (ECERH) Physical Medicine and Rehabilitation (PMR) annex building between September 2023 and March 2024. The study protocol was approved by the ethics committee of the same university (2023-03/03).
- Conditions
- Knee Osteoarthritis, Pain, Physical Disability
- Being tested
- hip device-assisted concentric abductor strengthening (HDACAS), knee device-assisted concentric flexor-extensor strengthening (KDACFES)
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip device-assisted concentric abductor strengthening (HDACAS)Device
All participants received device-assisted strengthening exercises with increasing doses according to a pre-determined strengthening program for a total of 6 weeks, 4 days a week, and a total of 24 sessions
knee device-assisted concentric flexor-extensor strengthening (KDACFES)Device
All participants received device-assisted strengthening exercises with increasing doses according to a pre-determined strengthening program for a total of 6 weeks, 4 days a week, and a total of 24 sessions
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | The study group received hip device-assisted concentric abductor strengthening (HDACAS) program in addition to knee device-assisted concentric flexor-extensor strengthening (KDACFES) program. Receives: Device: hip device-assisted concentric abductor strengthening (HDACAS); Device: knee device-assisted concentric flexor-extensor strengthening (KDACFES) |
| Control group | Active comparator | The control group received only KDACFES program Receives: Device: knee device-assisted concentric flexor-extensor strengthening (KDACFES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities (WOMAC)
Assessments consist of three components: pain, stiffness, and functionality. The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status. The higher the score, the poorer the function.
Measured: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
The Lequesne Algofunctional index
It is a disease-specific measure used to assess the pain, maximum walking distance, and daily life activities of knee osteoarthritis patients.
The Lequesne Algofunctional index has an interview format questionnaire, including 10 questions divided into three sections regarding pain, maximum distance walked and activities of daily living. The score ranges from 0 (no pain, no disability) to 24 (maximum pain and disability.
Measured: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
TIME UP AND GO TEST
With this test, patients' ability to maintain balance during transfer and walking is assessed. One source suggests that scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention.
Measured: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
30 SECOND CHAIR TEST
This test requires the individual to sit and stand continuously for 30 seconds with arms crossed over the chest and is based on the maximum number of repetitions the individual can perform. The 30-second chair stand involves recording the number of stands a person can complete in 30 seconds rather then the amount of time it takes to complete a pre-determined number of repetitions.Great: 19 or more reps in 30 seconds means your endurance and lower-body strength are above average. You have the greatest life expectancy. Average: Between 10 and 18 reps indicates average endurance and lower-body strength. Poor: 9 reps or fewer should be considered a warning sign.
Measured: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
40 METER SELF PACED WALK TEST
It is a test focused on measuring mobility and function. It is based on walking a certain distance in the fastest possible time, competing against time. A fast-paced walking test that is timed over 4 x 10m (33 ft) for a total 40 m (132 ft) (2). As a direct measure of the ability to walk quickly over short distances, which is an activity that is important but often limited in people with hip and/or knee OA. Regular walking aid is allowed and recorded. Time of one trial, with turn time excluded, is recorded and expressed as speed m/s by dividing distance (40 m) by time (s)
Measured: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
SIX MINUTES WALK TEST
The 6-minute walk test, which is a reliable and valid mobility test for measuring walking activity, is the most commonly used test in clinical trials. The maximum distance that can be walked over a 6-min interval is recorded. Rest periods are allowed but included in the time Standardized encouragement (e.g., keep going you are doing really well") can be given at minute intervals. Regular walking aid is allowed. Practice test not needed in most clinical settings but if performed then at least 1 h rest should be allowed before the second test. The greatest distance is then recorded
Measured: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
STAIR CLIMB TEST
It is a test that varies in the number of steps, but the most commonly used and the version found on the OARSI website is the 9-step stair climb test. Ascend and descend flight of nine stairs in a usual manner, and at a safe and comfortable pace. Use of any walking aid and handrail is permitted and recorded. Total time to ascend and descend steps for one trial is recorded in seconds
Measured: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
Secondary outcomes (2)
Visual Analog Scale (VAS)
The intensity of pain ranges from '0' to '10', with '0' indicating no pain and '10' representing the worst pain the person has ever experienced in their life
Measured: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
Mini Osteoarthritis Knee and Hip Quality of Life Scale
It is derived from the original Osteoarthritis Knee and Hip Quality of Life (OAKHQoL) questionnaire, developed to assess Health-Related Quality of Life (HRQoL) in patients with knee and/or hip osteoarthritis. It includes five subscales: physical activities, mental health, pain, social support, social functioning; with three additional independent items addressing sexual life, professional life, and fear of being dependent. The numerical rating scales in the items range from 0 (worst) to 10 (best). Scores were obtained by computing the means of the item scores in each subscale. The last three items' score (independent items) becomes the corresponding score.
Measured: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start20 Sep 2023
- Primary completion29 Mar 2024
- Study completion29 Mar 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.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- 1. STUDY GROUP 2. CONTROL GROUP
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Hüseyin Gökpınar, Kutahya Health Sciences University
- Investigators
- Hasan H Gökpınar, Study director, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331858
- Sponsor's protocol ID
- KutahyaHSU-DRGOKPINARDROMER-43
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2024
- Last updated
- 11 Mar 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding Instrumented Hip Concentric Abductor Strengthening Exercise to Instrumented Knee Flexor-Extensor Concentric Strengthening Exercise on Pain, Function, Physical Performance, and Quality of Life in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06331858
- Acronym / sponsor ID
- KutahyaHSU-DRGOKPINARDROMER-43
- Conditions
- Knee Osteoarthritis, Pain, Physical Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2024 (actual)
- First posted
- 26 Mar 2024 (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.
The aim of this study was to investigate the effectiveness of adding hip device-assisted concentric abductor strengthening (HDACAS) program to knee device-assisted concentric flexor-extensor strengthening (KDACFES) program on pain, function, physical performance, quality of life and gait parameters in patients with knee osteoarthritis (OA).
Detailed description
This prospective randomized single-blind controlled study was conducted at Kütahya Health Sciences University (KHSU) Evliya Çelebi Education and Research Hospital (ECERH) Physical Medicine and Rehabilitation (PMR) annex building between September 2023 and March 2024. The study protocol was approved by the ethics committee of the same university (2023-03/03).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 1. STUDY GROUP 2. CONTROL GROUP
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Device: hip device-assisted concentric abductor strengthening (HDACAS), Device: knee device-assisted concentric flexor-extensor strengthening (KDACFES)The study group received hip device-assisted concentric abductor strengthening (HDACAS) program in addition to knee device-assisted concentric flexor-extensor strengthening (KDACFES) program. |
| Control group | Active comparator | Device: knee device-assisted concentric flexor-extensor strengthening (KDACFES)The control group received only KDACFES program |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Receiving a diagnosis of knee osteoarthritis according to the ACR criteria and being classified as stage 2-3 according to the Kellgren Lawrence staging
- Having symptomatic unilateral or bilateral knee pain with a VAS (0-10) pain score > 4
- Being able to ambulate independently without orthosis/prosthesis
- Having a body mass index less than 35
Key exclusion criteria (9 listed)
- History of knee and hip surgery
- Presence of lesions, atrophy, or scars in the skin area
- Intra-articular injection to the knee within the last 6 months
- Receiving active physiotherapy, physical therapy, or spa treatment in the last 6 months
- Patients with chronic diseases such as COPD, coronary artery disease
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 |
|---|---|---|
| hip device-assisted concentric abductor strengthening (HDACAS)All participants received device-assisted strengthening exercises with increasing doses according to a pre-determined strengthening program for a total of 6 weeks, 4 days a week, and a total of 24 sessions | Device | Study group |
| knee device-assisted concentric flexor-extensor strengthening (KDACFES)All participants received device-assisted strengthening exercises with increasing doses according to a pre-determined strengthening program for a total of 6 weeks, 4 days a week, and a total of 24 sessions | Device | Control group, Study group |
Primary outcome
Western Ontario and McMaster Universities (WOMAC)
Time frame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
Assessments consist of three components: pain, stiffness, and functionality. The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Scores range from 0 to 96 for the total WOMAC where 0 represents the best health status and 96 the worst possible status. The higher the score, the poorer the function.
The Lequesne Algofunctional index
Time frame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
It is a disease-specific measure used to assess the pain, maximum walking distance, and daily life activities of knee osteoarthritis patients. The Lequesne Algofunctional index has an interview format questionnaire, including 10 questions divided into three sections regarding pain, maximum distance walked and activities of daily living. The score ranges from 0 (no pain, no disability) to 24 (maximum pain and disability.
TIME UP AND GO TEST
Time frame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
With this test, patients' ability to maintain balance during transfer and walking is assessed. One source suggests that scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention.
30 SECOND CHAIR TEST
Time frame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
This test requires the individual to sit and stand continuously for 30 seconds with arms crossed over the chest and is based on the maximum number of repetitions the individual can perform. The 30-second chair stand involves recording the number of stands a person can complete in 30 seconds rather then the amount of time it takes to complete a pre-determined number of repetitions.Great: 19 or more reps in 30 seconds means your endurance and lower-body strength are above average. You have the greatest life expectancy. Average: Between 10 and 18 reps indicates average endurance and lower-body strength. Poor: 9 reps or fewer should be considered a warning sign.
40 METER SELF PACED WALK TEST
Time frame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
It is a test focused on measuring mobility and function. It is based on walking a certain distance in the fastest possible time, competing against time. A fast-paced walking test that is timed over 4 x 10m (33 ft) for a total 40 m (132 ft) (2). As a direct measure of the ability to walk quickly over short distances, which is an activity that is important but often limited in people with hip and/or knee OA. Regular walking aid is allowed and recorded. Time of one trial, with turn time excluded, is recorded and expressed as speed m/s by dividing distance (40 m) by time (s)
SIX MINUTES WALK TEST
Time frame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
The 6-minute walk test, which is a reliable and valid mobility test for measuring walking activity, is the most commonly used test in clinical trials. The maximum distance that can be walked over a 6-min interval is recorded. Rest periods are allowed but included in the time Standardized encouragement (e.g., keep going you are doing really well") can be given at minute intervals. Regular walking aid is allowed. Practice test not needed in most clinical settings but if performed then at least 1 h rest should be allowed before the second test. The greatest distance is then recorded
STAIR CLIMB TEST
Time frame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
It is a test that varies in the number of steps, but the most commonly used and the version found on the OARSI website is the 9-step stair climb test. Ascend and descend flight of nine stairs in a usual manner, and at a safe and comfortable pace. Use of any walking aid and handrail is permitted and recorded. Total time to ascend and descend steps for one trial is recorded in seconds
2 secondary outcomes
Visual Analog Scale (VAS)
Time frame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
Mini Osteoarthritis Knee and Hip Quality of Life Scale
Time frame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)
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 11 Mar 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.
Hasan H Gökpınar study director
Kutahya Health Sciences 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 hip device-assisted concentric abductor strengthening (HDACAS) and knee device-assisted concentric flexor-extensor strengthening (KDACFES) in people with Knee Osteoarthritis and Pain, run by Kutahya Health Sciences 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 4 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 11 Mar 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?
Western Ontario and McMaster Universities (WOMAC) (time frame: TIME FRAME 1: pre-intervention (up to 72 hours), TIME FRAME 2: post-intervention(up to 72 hours)). The study lists 7 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 11 Mar 2025.