Neuromuscular Control and Motor Unit Behavior in Patients With Knee Osteoarthritis
Neuromuscular Control and Motor Unit Behavior in Patients With Knee Osteoarthritis: a Randomized Single-blind Trial of Muscle Training and Knee Orthosis Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Sham Comparator: controls group
|
The isometric knee-extension strengthening program from session 1 to session 9 as follows:
|
|
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.
|
The isometric knee-extension strengthening program from session 1 to session 9 as follows:
|
|
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.
|
The isometric knee-extension strengthening program from session 1 to session 9 as follows:
|
What is the study measuring?
Primary Outcome Measures
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
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-ER-114-259
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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