Neuromuscular Control and Motor Unit Behavior in Patients With Knee Osteoarthritis

NCT07544693 | Not Yet Recruiting

• 1 other identifier: A-ER-114-259
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Knee Osteoarthritis (Knee OA)

Keywords

Orthotic Devices; knee osteoarthritis

Outcome Measures

Primary Outcomes (5)

• maximal voluntary isometric contraction (MVC)

  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).

  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.

  Baseline and 3 weeks

• Motor Unit Recruitment (amplitude relative to recruitment threshold)

  surface EMG decomposition

  Baseline and 3 weeks

• Motor Unit Recruitment (firing rate relative to recruitment threshold)

  surface EMG decomposition

  Baseline and 3 weeks

Study Arms (3)

controls group

SHAM COMPARATOR

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.

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.

Behavioral: the strengthening program

Interventions

the strengthening program BEHAVIORAL

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.

Group A with the corrective knee orthosis; Group B without the corrective knee orthosis; controls group

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Medicine

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 22, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04