Knee Osteoarthritis (Knee OA)NCT07544693
Neuromuscular Control and Motor Unit Behavior in Patients With Knee Osteoarthritis
A study testing the strengthening program in people with Knee Osteoarthritis (Knee OA), run by Kaohsiung Veterans General Hospital..
Trial summary
This study aims to examine the effects of moderate-intensity strength training, performed with or without an unloading knee orthosis (valgus-corrective or sham mode), on muscle function, motor unit behavior, and force modulation in patients with moderate knee osteoarthritis Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis (Knee OA)
- What is being tested?
- the strengthening program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. age 55 to 75 years.
- 2. Diagnosed with moderate knee traumatic arthritis (Kellgren-Lawrence classification II or III)(experimental group).
- The control group must not have a diagnosis of osteoarthritis of the knee and must have normal knee joint function.
- 3. Physical Health Status: Able to perform basic movements requiring isometric knee contraction tests and electromyography recording.
- 4. Able to wear knee orthotics.
Who cannot join
- 1. Knee or lower extremity injury: Recent (within the past 6 months) history of severe injury, fracture, or surgery to the knee or lower extremity.
- 2. Other joint disorders: Coexisting joint disorders (such as rheumatoid arthritis or gouty arthritis).
- 3. Neuromuscular disorders: Presence of neuromuscular dysfunction, such as stroke, Parkinson's disease, or peripheral neuropathy.
- 4. Uncontrolled cardiovascular disease, hypertension, diabetes, or other medical conditions.
- Taking medications that affect neuromuscular function.
- 5. Allergy or intolerance: Allergy to laboratory equipment (such as electromyography electrode gel) or knee brace materials.
About this study
Official title: Neuromuscular Control and Motor Unit Behavior in Patients With Knee Osteoarthritis: a Randomized Single-blind Trial of Muscle Training and Knee Orthosis Intervention
This study aims to examine the effects of moderate-intensity strength training, performed with or without an unloading knee orthosis (valgus-corrective or sham mode), on muscle function, motor unit behavior, and force modulation in patients with moderate knee osteoarthritis
- Conditions
- Knee Osteoarthritis (Knee OA)
- Being tested
- the strengthening program
- Keywords
- Orthotic Devices, knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the strengthening programBehavioural
The isometric knee-extension strengthening program from session 1 to session 9 as follows:
- Before the first training session each week, one-repetition maximum (1RM) will be measured to determine the training intensity for that week.
- Training frequency: Three sessions per week on non-consecutive days, for a total of 3 weeks (9 sessions).
- Training intensity: 60% of 1RM. The goal is to improve quadriceps strength and endurance while reducing joint loading.
- Each session will consist of four sets: 30 repetitions in the first set and 15 repetitions in sets 2-4.
- Rest intervals of 30 seconds will be provided between sets, during which the blood-flow-restriction device will remain in place.
| Study group | Role | What they receive |
|---|---|---|
| controls group | Sham comparator | Not described Receives: Behavioral: the strengthening program |
| Group A with the corrective knee orthosis | Experimental | patients with moderate knee osteoarthritis (Kellgren-Lawrence grade II-III) who will receive a valgus-corrective knee orthosis. Receives: Behavioral: the strengthening program |
| Group B without the corrective knee orthosis | Placebo comparator | patients with moderate knee osteoarthritis (Kellgren-Lawrence grade II-III) who will not receive a valgus-corrective knee orthosis. Receives: Behavioral: the strengthening program |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal voluntary isometric contraction (MVC)
Measured: Baseline and 3 weeks
The Western Ontario and McMaster Universities Turkish (WOMAC) index
a self-administered questionnaire that assesses three aspects of a patient's health status -pain, stiffness, and physical function - in those with lower limb Osteoarthritis.
WOMAC consists of 24 questions, with a total score ranging from 0 to 96 points.
there are three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions).
a five-tier classification of symptomatic severity: minimal or no symptoms (≤24 score), mild (25-41 score), moderate (42-69 score), severe (70-86 score), and extreme (≥87 score).
Measured: baseline, 3 weeks
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems.
Knee Injury and Osteoarthritis Outcome Score (KOOS) has
five subscales: pain (9 questions), symptoms (7 questions), activities of daily living (17 questions), sport/recreation (5 questions), knee-related quality of life (4 questions).
The total score of each question (0-4 points) is converted into a score of 0-100, where 100 points represents the best knee health and 0 points represents the worst.
Measured: Baseline and 3 weeks
Motor Unit Recruitment (amplitude relative to recruitment threshold)
surface EMG decomposition
Measured: Baseline and 3 weeks
Motor Unit Recruitment (firing rate relative to recruitment threshold)
surface EMG decomposition
Measured: Baseline and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Osteoarthritis (Knee OA)Studies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHEN YUEH, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544693
- Sponsor's protocol ID
- A-ER-114-259
- Status last verified
- Apr 2026
- First submitted
- 12 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Control and Motor Unit Behavior in Patients With Knee Osteoarthritis: a Randomized Single-blind Trial of Muscle Training and Knee Orthosis Intervention
- ClinicalTrials.gov ID
- NCT07544693
- Acronym / sponsor ID
- A-ER-114-259
- Conditions
- Knee Osteoarthritis (Knee OA)
- Keywords
- Orthotic Devices, knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Apr 2026 (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 aims to examine the effects of moderate-intensity strength training, performed with or without an unloading knee orthosis (valgus-corrective or sham mode), on muscle function, motor unit behavior, and force modulation in patients with moderate knee osteoarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| controls group | Sham comparator | Behavioral: the strengthening program |
| Group A with the corrective knee orthosis | Experimental | Behavioral: the strengthening programpatients with moderate knee osteoarthritis (Kellgren-Lawrence grade II-III) who will receive a valgus-corrective knee orthosis. |
| Group B without the corrective knee orthosis | Placebo comparator | Behavioral: the strengthening programpatients with moderate knee osteoarthritis (Kellgren-Lawrence grade II-III) who will not receive a valgus-corrective knee orthosis. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. age 55 to 75 years.
- 2. Diagnosed with moderate knee traumatic arthritis (Kellgren-Lawrence classification II or III)(experimental group).
- The control group must not have a diagnosis of osteoarthritis of the knee and must have normal knee joint function.
- 3. Physical Health Status: Able to perform basic movements requiring isometric knee contraction tests and electromyography recording.
- 4. Able to wear knee orthotics.
Key exclusion criteria (6 listed)
- 1. Knee or lower extremity injury: Recent (within the past 6 months) history of severe injury, fracture, or surgery to the knee or lower extremity.
- 2. Other joint disorders: Coexisting joint disorders (such as rheumatoid arthritis or gouty arthritis).
- 3. Neuromuscular disorders: Presence of neuromuscular dysfunction, such as stroke, Parkinson's disease, or peripheral neuropathy.
- 4. Uncontrolled cardiovascular disease, hypertension, diabetes, or other medical conditions.
- Taking medications that affect neuromuscular function.
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 |
|---|---|---|
| the strengthening programThe isometric knee-extension strengthening program from session 1 to session 9 as follows: 1. Before the first training session each week, one-repetition maximum (1RM) will be measured to determine the training intensity for that week. 2. Training frequency: Three sessions per week on non-consecutive days, for a total of 3 weeks (9 sessions). 3. Training intensity: 60% of 1RM. The goal is to improve quadriceps strength and endurance while reducing joint loading. 4. Each session will consist of four sets: 30 repetitions in the first set and 15 repetitions in sets 2-4. 5. Rest intervals of 30 seconds will be provided between sets, during which the blood-flow-restriction device will remain in place. | Behavioural | Group A with the corrective knee orthosis, Group B without the corrective knee orthosis, controls group |
Primary outcome
maximal voluntary isometric contraction (MVC)
Time frame: Baseline and 3 weeks
The Western Ontario and McMaster Universities Turkish (WOMAC) index
Time frame: baseline, 3 weeks
a self-administered questionnaire that assesses three aspects of a patient's health status -pain, stiffness, and physical function - in those with lower limb Osteoarthritis. WOMAC consists of 24 questions, with a total score ranging from 0 to 96 points. there are three subscales: pain (5 questions), stiffness (2 questions), and physical function (17 questions). a five-tier classification of symptomatic severity: minimal or no symptoms (≤24 score), mild (25-41 score), moderate (42-69 score), severe (70-86 score), and extreme (≥87 score).
The Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline and 3 weeks
a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. Knee Injury and Osteoarthritis Outcome Score (KOOS) has five subscales: pain (9 questions), symptoms (7 questions), activities of daily living (17 questions), sport/recreation (5 questions), knee-related quality of life (4 questions). The total score of each question (0-4 points) is converted into a score of 0-100, where 100 points represents the best knee health and 0 points represents the worst.
Motor Unit Recruitment (amplitude relative to recruitment threshold)
Time frame: Baseline and 3 weeks
surface EMG decomposition
Motor Unit Recruitment (firing rate relative to recruitment threshold)
Time frame: Baseline and 3 weeks
surface EMG decomposition
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing the strengthening program in people with Knee Osteoarthritis (Knee OA), run by Kaohsiung Veterans General Hospital..
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 6 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: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
maximal voluntary isometric contraction (MVC) (time frame: Baseline and 3 weeks). The study lists 5 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 22 Apr 2026.