- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03470090
The Effects of Neuromuscular Exercises Training on Physical Activity, Functionality and Balance in Knee Osteoarthritis
Assessment Effects of Neuromuscular Exercises Training on Physical Activity, Functionality and Balance in Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Malatya, Turkey, 44100
- Malatya Gozde Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients with knee osteoarthritis,
- individuals without a physical disability,
- person in an age range 35- 65 years,
- Having no any knee surgeon,
- Mentally that is sufficient to make assessments,
- Who want to be involved voluntary work,
- Ability to adjust the training program
- Individuals who received informed consent
Exclusion Criteria:
- Individuals who do not allow mental evaluation
- Individuals who do not want to be involved in voluntary work.
- Clinical study refused to participate in.
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 |
|---|---|
|
Experimental: Neuromuscular Exercises Group
This group of patients received patient with knee osteoarthritis.
It will be applied classical physiotherapy and neuromuscular exercises training
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In the experimental group, the subjects who were taken into the study were taken to the neuromuscular exercise (NME) program after the pre-treatment evaluations.
The subjects in this group were given classical physiotherapy and NME performed 6 days a week, 1 set of 10 times physiotherapist control.
NME was including warming, neuromuscular exercises (balance, muscle strengthening, proprioception, sensorimotor system training, joint stabilization and postural control exercises) and cooling periods.
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Active Comparator: Conventional Group
This group of patients received patient with knee osteoarthritis.
It will be applied classical physiotherapy and conventional exercises.
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In the control group, the subjects who were taken into the study were taken to the classical physiotherapy (hotpack (HP), ultrasound (US), transcutaneous electrical stimulation (TENS)) and conventional exercises program after the pre-treatment evaluations.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) of patients with knee osteoarthritis at 6 weeks.
Time Frame: 6 weeks
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The scale used to measure knee function (0-100 total score). High scores indicate poor function status and low scores indicate good function status. The scale contains 24 questions, three subgroups of pain, stiffness and physical function. There are 5 alternative answers to the questions: 0 = no, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The rating (total of all answers / 96) was calculated as * 100. |
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changed from Visual Analog Scale (VAS) of patients with knee osteoarthritis at 6 weeks.
Time Frame: 6 weeks
|
It used to measure level of pain (0-100 mm).
On a horizontal line of 100 millimeters (mm), the initial 0 (no pain) and end (pain at unbearable grade) were marked.
It was requested to place a mark on this horizontal line according to the degree of pain they felt in the cases.
The point marked on the line was then recorded as a VAS value in mm, measured by a ruler.
|
6 weeks
|
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Change from International Physical Activity Questionnaire (IPAQ) Short Form of patients with knee osteoarthritis at 6 weeks.
Time Frame: 6 weeks
|
It used to measure level of physical activity.
IPAQ short form; 7 questions that provide information about time spent on walking, moderate to severe activities, and time spent sitting.
The energy required for the activities was calculated by the MET-minute score.
Standard MET values for these activities are: Walk = 3,3 MET; Moderate Severe Physical Activity = 4,0 MET; Severe Physical Activity = 8.0 MET; Seating = 1,5 MET.
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6 weeks
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Change from Y Balance Test of patients with knee osteoarthritis at 6 weeks.
Time Frame: 6 weeks
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It used to measure static balance.Anterior (A), Posteromedial (PM) and posterolateral (PL) measurements were performed.
It was glued to three graves at 120 degrees.
The patient was asked to put one foot on the intersection of these three bombers and to lie in directions A, PM, and PL with the other foot.
During the test, the patient was asked to point to the maximum point he could reach without touching his foot and to bring it to the stable foot without losing balance.
The distance is measured in centimeters.
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6 weeks
|
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Change from 2000 International Knee Documentation Committee (IKDC) of patients with knee osteoarthritis at 6 weeks.
Time Frame: 6 weeks
|
It used to measure functionality. The questionnaire consists of 10 questions in total. 0 is the worst level of activity when measuring activity level; 4 is answered for the maximum level of activity. Similarly, when evaluating frequency, 0 is the most severe, 10 is not. 0-100 total score. |
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Burcu Talu, PhD, Inonu University
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 (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/72
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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