The Effects of Neuromuscular Exercises Training on Physical Activity, Functionality and Balance in Knee Osteoarthritis
Primary Purpose
Exercise, Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Neuromuscular Exercises
Conventional Group
Sponsored by
About this trial
This is an interventional treatment trial for Exercise focused on measuring Physical activity, Function, Balance, Neuromuscular exercises, Osteoarthritis
Eligibility Criteria
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.
Sites / Locations
- Malatya Gozde Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Neuromuscular Exercises Group
Conventional Group
Arm Description
This group of patients received patient with knee osteoarthritis. It will be applied classical physiotherapy and neuromuscular exercises training
This group of patients received patient with knee osteoarthritis. It will be applied classical physiotherapy and conventional exercises.
Outcomes
Primary Outcome Measures
Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) of patients with knee osteoarthritis at 6 weeks.
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.
Secondary Outcome Measures
Changed from Visual Analog Scale (VAS) of patients with knee osteoarthritis at 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.
Change from International Physical Activity Questionnaire (IPAQ) Short Form of patients with knee osteoarthritis at 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.
Change from Y Balance Test of patients with knee osteoarthritis at 6 weeks.
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.
Change from 2000 International Knee Documentation Committee (IKDC) of patients with knee osteoarthritis at 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03470090
Brief Title
The Effects of Neuromuscular Exercises Training on Physical Activity, Functionality and Balance in Knee Osteoarthritis
Official Title
Assessment Effects of Neuromuscular Exercises Training on Physical Activity, Functionality and Balance in Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
December 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was planned to evaluate the effect of neuromuscular exercise program on physical activity, functionality and balance in patients with knee osteoarthritis aged 35-65 years.
Detailed Description
The degeneration that occurs in the osteoarthritis of the knee joint leads to the loss of proprioception, resulting in the misalignment of the mechanoreceptors in that region, the joint stabilization is impaired, the muscles do not fulfill the protective role and the joint neuromuscular is inadequate for control. Neuromuscular control is the subcortical activity of effector structures against stimulation with mechanoreceptor, visual, and vestibular affinities. Proprioception, kinesthesia, sensation of joint position, visual and vestibular information constitute sensory data; functional motor patterns, dynamic joint stability and reactive neuromuscular control motor efferent response definitions. Disturbance of neuromuscular control of the muscles also affects walking and balance with abnormal weight transfer. There are many ways to treat knee osteoarthritis such as patient education, weight control, different physical therapy modalities (hot, cold, electrotherapy, deep heat), exercise, pharmacological treatments (topical, systemic, intraarticular). There is no radical treatment of osteoarthritis to restore structural changes; but with the treatment applied, findings such as pain and loss of function of the individual can be reduced and the patients become more independent in daily life activities. Surgical treatment is the last resort in osteoarthritis. In osteoarthritis( OA), there is no pharmacological method to treat the deformed joint structure that will change the course of the disease. This situation significantly increases the importance of rehabilitation in the treatment of osteoarthritis. The aim of neuromuscular rehabilitation that reestablish and regulated features such as dynamic joint stability, reactive neuromuscular control, functional motor patterns. Rehabilitation programs created for this purpose include balance exercises, strengthening exercises, postural control, functional exercises, postural orientation, flexibility, agility, plyometric exercises, spore-specific exercises. neuromuscular exercise program includes 7 parameters including functional mobility, functional stability, sensorimotor system training, proprioceptive neuromuscular facilitation training techniques, plyometric exercises, reactive neuromuscular system training, technical training. Main purpose of this study is that the effect of neuromuscular exercise program on physical activity, functionality and balance in patients with knee osteoarthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise, Osteoarthritis
Keywords
Physical activity, Function, Balance, Neuromuscular exercises, Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental, Randomized Controlled Study
Masking
Participant
Masking Description
Participants didn't know taking which exercise treatment methods.
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neuromuscular Exercises Group
Arm Type
Experimental
Arm Description
This group of patients received patient with knee osteoarthritis. It will be applied classical physiotherapy and neuromuscular exercises training
Arm Title
Conventional Group
Arm Type
Active Comparator
Arm Description
This group of patients received patient with knee osteoarthritis. It will be applied classical physiotherapy and conventional exercises.
Intervention Type
Behavioral
Intervention Name(s)
Neuromuscular Exercises
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Conventional Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) of patients with knee osteoarthritis at 6 weeks.
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Changed from Visual Analog Scale (VAS) of patients with knee osteoarthritis at 6 weeks.
Description
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.
Time Frame
6 weeks
Title
Change from International Physical Activity Questionnaire (IPAQ) Short Form of patients with knee osteoarthritis at 6 weeks.
Description
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.
Time Frame
6 weeks
Title
Change from Y Balance Test of patients with knee osteoarthritis at 6 weeks.
Description
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.
Time Frame
6 weeks
Title
Change from 2000 International Knee Documentation Committee (IKDC) of patients with knee osteoarthritis at 6 weeks.
Description
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.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burcu Talu, PhD
Organizational Affiliation
Inonu University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malatya Gozde Hospital
City
Malatya
ZIP/Postal Code
44100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effects of Neuromuscular Exercises Training on Physical Activity, Functionality and Balance in Knee Osteoarthritis
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