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NCT Number: NCT07544693

Neuromuscular Control and Motor Unit Behavior in Patients With Knee Osteoarthritis

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

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Key information

Conditions

Knee Osteoarthritis (Knee OA) Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. age 55 to 75 years.
  • 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.

  • Physical Health Status: Able to perform basic movements requiring isometric knee contraction tests and electromyography recording.
  • 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.
  • Other joint disorders: Coexisting joint disorders (such as rheumatoid arthritis or gouty arthritis).
  • Neuromuscular disorders: Presence of neuromuscular dysfunction, such as stroke, Parkinson's disease, or peripheral neuropathy.
  • Uncontrolled cardiovascular disease, hypertension, diabetes, or other medical conditions.

Taking medications that affect neuromuscular function.

  • Allergy or intolerance: Allergy to laboratory equipment (such as electromyography electrode gel) or knee brace materials.

Treatment and study plan

the strengthening program

Behavioral

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.

Primary outcomes

  1. maximal voluntary isometric contraction (MVC)

    Time frame: Baseline and 3 weeks

  2. 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).

  3. 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.

  4. Motor Unit Recruitment (amplitude relative to recruitment threshold)

    Time frame: Baseline and 3 weeks

    surface EMG decomposition

  5. Motor Unit Recruitment (firing rate relative to recruitment threshold)

    Time frame: Baseline and 3 weeks

    surface EMG decomposition

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

Neuromuscular Control and Motor Unit Behavior in Patients With Knee Osteoarthritis: a Randomized Single-blind Trial of Muscle Training and Knee Orthosis Intervention

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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