Neuromuscular Control and Motor Unit Behavior in Patients With Knee Osteoarthritis

April 18, 2026 updated by: CHEN YUEH, Kaohsiung Veterans General Hospital.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: controls group
Behavioral: the strengthening program

The 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.
Experimental: Group A with the corrective knee orthosis
patients with moderate knee osteoarthritis (Kellgren-Lawrence grade II-III) who will receive a valgus-corrective knee orthosis.
Behavioral: the strengthening program

The 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.
Placebo Comparator: Group B without the corrective knee orthosis
patients with moderate knee osteoarthritis (Kellgren-Lawrence grade II-III) who will not receive a valgus-corrective knee orthosis.
Behavioral: the strengthening program

The 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
maximal voluntary isometric contraction (MVC)
Time Frame: Baseline and 3 weeks
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).
baseline, 3 weeks
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.
Baseline and 3 weeks
Motor Unit Recruitment (amplitude relative to recruitment threshold)
Time Frame: Baseline and 3 weeks
surface EMG decomposition
Baseline and 3 weeks
Motor Unit Recruitment (firing rate relative to recruitment threshold)
Time Frame: Baseline and 3 weeks
surface EMG decomposition
Baseline and 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaohsiung Veterans General Hospital.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A-ER-114-259

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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