- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06270329
Neuromuscular Training Program in Patients With Knee OA (Osteoarthritis) (OA)
Comparison of the Effectiveness of Neuromuscular Training Program and Conventional Physical Therapy Program in Patients With Knee Osteoarthritis.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kütahya, Turkey, 43100
- Kutahya Health Science University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having grade 2 or 3 osteoarthritis according to the Kellgren and Lawrence Classification
- Having pain score of 2 or above on VAS
- Not having received physical therapy in the last 3 months
- Not having received an intra-articular corticosteroid injection in the last 6 months
- Not having used oral corticosteroids in the last month
- Being between the ages of 40-80
- Body mass index being between 19-40 kg/cm2
Exclusion Criteria:
- Systemic arthritis
- Hypertensive condition that prevents exercise
- Pregnancy, cognitive impairment, parkinson-like neurological disorders
- Having had a knee or hip joint replacement
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: neuromuscular training program
Participants were administered the neuromuscular training program 60 min a day, 2 days a week for 8 weeks.
|
Hotpack application TENS (transcutaneous electrical stimulation) Warm-up phase: bicycle ergometer (ten minutes) Exercise phase: core stabilization and postural control exercises postural orientation exercises lower extremity strengthening exercises functional exercises (balance and proprioception exercises using a balance board) Cool-down Phase |
|
Active Comparator: conventional physical therapy program
Participants were administered the conventional physiotherapy program 60 min a day, 2 days a week for 8 weeks.
|
Hotpack application TENS (transcutaneous electrical stimulation) Conventional physical therapy exercises (straight leg raises, knee flexor and extensor strengthening, hip muscle strengthening)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: At first and third week
|
Pain evaluation.
The participant is asked to give a score between 1 and 10 for her pain.
|
At first and third week
|
|
Western Ontario and McMasterUniversities Osteoarhritis Index
Time Frame: At first and third week
|
Functional status evaluation. The scale consists of 3 subheadings that evaluate pain, stiffness and physical function. High Western Ontario and McMasterUniversities Osteoarhritis Index score indicates increased pain and stiffness and deterioration in physical function. |
At first and third week
|
|
Time on One Leg Standing
Time Frame: At first and third week
|
Balance evaluation.
Participants were asked to stand on one leg with their eyes open for as long as possible, and the time was measured with a stopwatch and recorded in seconds.
|
At first and third week
|
|
Five Times Sit to Stand Test
Time Frame: At first and third week
|
Physical performance evaluation.
The time it takes for the patient to sit and stand up from a chair five times is recorded.
As time decreases, it indicates better performance.
|
At first and third week
|
|
Manual Muscle Test
Time Frame: At first and third week
|
Muscle strength evaluation.
A score between 0 and 5 is given depending on muscle strength.
|
At first and third week
|
|
Short Form
Time Frame: At first and third week
|
Quality of life evaluation. It consists of 8 subheadings: physical function, problems caused by physical problems, emotional well-being, problems caused by emotional problems, general health, social function, pain, energy/fatigue. High scores indicate good health, low scores indicate poor health. |
At first and third week
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NMTwithKOA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Knee Osteoarthritis
-
Istanbul University - CerrahpasaCompletedKnee Osteoarthritis | Knee Osteoarthritis (Knee OA)Turkey (Türkiye)
-
Edin MešanovićCompletedOsteoarthritis | Osteoarthritis of the Knee | Osteoarthritis of Knee | Osteoarthritis of the Knees | Osteoarthritis (OA) of the Knee | Osteoarthritis Knee | Osteoarthritis in the Knee | Osteoarthritis of Knee JointBosnia and Herzegovina
-
Golden Jubilee National HospitalJohnson & Johnson; DePuy OrthopaedicsNot yet recruitingOsteoarthritis | Knee Osteoarthritis | Osteoarthritis (OA) | Osteo Arthritis | Osteoarthritis in the Knee | Osteoarthritis (Knee) | Osteo Arthritis of the KneeUnited Kingdom
-
Dr. David WassersteinSunnybrook Research InstituteRecruitingKnee Osteoarthritis (Knee OA) | Knee Osteoarthritis (OA)Canada
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
Lucas R. Cusumano, MDNot yet recruitingKnee Osteoarthritis | Knee Discomfort | Knee Pain Chronic | Knee Swelling PainUnited States
-
Emory UniversityVertex Pharmaceuticals IncorporatedNot yet recruitingKnee Osteoarthritis | Knee ArthritisUnited States
-
VA Office of Research and DevelopmentNot yet recruitingKnee Osteoarthritis (Knee OA)United States
-
The Hong Kong Polytechnic UniversityChinese University of Hong Kong; Zhujiang HospitalNot yet recruitingKnee Osteoarthritis (Knee OA)
-
University of MiamiNot yet recruiting
Clinical Trials on Neuromuscular training program
-
Western Norway University of Applied SciencesCompleted
-
Region SkaneCompleted
-
St. Mary's University, TwickenhamRecruitingObesity | Childhood ObesityUnited Kingdom
-
St Mary's University CollegeNot yet recruiting
-
Istanbul University - CerrahpasaRecruitingMotoric Cognitive Risk Syndrome | Elderly (People Aged 65 or More) | Geriatric Patient | Exergaming | Neuromuscular ExerciseTurkey (Türkiye)
-
Yeditepe UniversityCompletedSports Physical Therapy | Pain, ShoulderTurkey (Türkiye)
-
Cairo UniversityRecruitingFatigue | HemodialysisEgypt
-
Montiha AzeemRecruitingDiabetic Peripheral NeuropathyPakistan
-
Riphah International UniversityCompletedSports Physical TherapyPakistan
-
University of Sao Paulo General HospitalRecruitingHeart Failure | Physical Therapy | Neuromuscular Electrical StimulationBrazil