Back to resultsEffect of Exercises on Dynamic Balance in Knee Osteoarthritis Patients.
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
stretching exercises
Transcutaneous electrical nerve stimulation
weight bearing strengthening exercises
Non-weight bearing strengthening exercises
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria: The patient's age > 50 years. Recent radiographs confirming the presence of knee OA, grade II-III (mild to moderate) Kellgren Lawrence (K/L). Body mass index (BMI) from 20 to 30 kg/m2. Met the American College of Rheumatology clinical criteria for mild to moderate knee OA. knee pain > 3 cm on a 10 cm visual analog scale (VAS) on most days of the previous week. Bilateral knee osteoarthritis. Exclusion Criteria: Congenital or acquired inflammatory or neurological (systemic or local) diseases involving the knee. Patients who have mental or cognitive illness that interfere their ability to perform the exercises or the evaluation tests. Intra articular knee injection of steroids in the past 6 months. Patients who had received joint replacement surgery in either Knee or hip. Patients with rheumatoid arthritis. Patients who received physical therapy sessions on the knee in the past 6 months.
Sites / Locations
- Faculty of physical therapy Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
weight bearing exercises group
non-weight bearing exercises group
Arm Description
20 patients were assigned to this group with bilateral knees osteoarthritis, they received TENS, stretching exercises and weight bearing strengthening exercises.
20 patients were assigned to this group with bilateral knees osteoarthritis, they received TENS, stretching exercises and Non-weight bearing strengthening exercises.
Outcomes
Primary Outcome Measures
change happened in the dynamic balance from the baseline
Biodex Balance System which is a device used to measure the balance of a person who stand on the platform of the device that give a measurement called over all stability index where 0 score means the best balance and the largest number indicate bad balance.
Secondary Outcome Measures
change happened in pain from the baseline
Visual Analog Scale which is a scale for pain from 0 to 10 where 0 mean no pain and 10 is the maximum pain.
change happened in the joint angle repositioning from baseline
Joint Repositioning Accuracy where the knee is moved passively to a certain angel and the patient hold it in this angle and then it moved to the start position and then the patient asked to move his knee joint actively to the previous the same previous angle then the absolute error between the true angle and the reproduced angle is measured.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05941117
Brief Title
Effect of Exercises on Dynamic Balance in Knee Osteoarthritis Patients.
Official Title
Effect of Weight Bearing Versus Non-weight Bearing Strengthening Exercises on Dynamic Balance in Knee Osteoarthritis Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is a randomized controlled trial which aims to compare the effect of weight bearing exercises and non-weight bearing exercises on the dynamic balance in knee osteoarthritis patients as 60 patients will divided in three groups where one group is control group and others two groups one of them perform weight bearing exercises and the other perform non weight bearing exercises.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
weight bearing exercises group
Arm Type
Active Comparator
Arm Description
20 patients were assigned to this group with bilateral knees osteoarthritis, they received TENS, stretching exercises and weight bearing strengthening exercises.
Arm Title
non-weight bearing exercises group
Arm Type
Active Comparator
Arm Description
20 patients were assigned to this group with bilateral knees osteoarthritis, they received TENS, stretching exercises and Non-weight bearing strengthening exercises.
Intervention Type
Combination Product
Intervention Name(s)
stretching exercises
Intervention Description
stretching exercises for Hamstring, quadriceps and calf muscle for both lower limbs of the same patients. each exercise was repeated 5 times and each repetition hold for 30 seconds in the same session.
Intervention Type
Combination Product
Intervention Name(s)
Transcutaneous electrical nerve stimulation
Other Intervention Name(s)
TENS
Intervention Description
it is one of the electrical stimulation modalities which is used to relief pain, each patient receive it on both knees every session.
Intervention Type
Combination Product
Intervention Name(s)
weight bearing strengthening exercises
Intervention Description
strengthening exercises for quadriceps, gluteus maximus, gluteus Medius and calf muscle in the form of weight bearing from standing position each exercise was repeated for 10 times with 5 seconds hold in the same set and patient perform three sets in the same session for both lower limbs.
Intervention Type
Combination Product
Intervention Name(s)
Non-weight bearing strengthening exercises
Intervention Description
strengthening exercises for quadriceps, gluteus maximus, gluteus Medius and calf muscle in the form of non-weight bearing from lying and setting positions each exercise was repeated for 10 times with 5 seconds hold in the same set and patient perform three sets in the same session for both lower limbs.
Primary Outcome Measure Information:
Title
change happened in the dynamic balance from the baseline
Description
Biodex Balance System which is a device used to measure the balance of a person who stand on the platform of the device that give a measurement called over all stability index where 0 score means the best balance and the largest number indicate bad balance.
Time Frame
one day after the end of treatment
Secondary Outcome Measure Information:
Title
change happened in pain from the baseline
Description
Visual Analog Scale which is a scale for pain from 0 to 10 where 0 mean no pain and 10 is the maximum pain.
Time Frame
one day after the end of treatment
Title
change happened in the joint angle repositioning from baseline
Description
Joint Repositioning Accuracy where the knee is moved passively to a certain angel and the patient hold it in this angle and then it moved to the start position and then the patient asked to move his knee joint actively to the previous the same previous angle then the absolute error between the true angle and the reproduced angle is measured.
Time Frame
one day after the end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient's age > 50 years.
Recent radiographs confirming the presence of knee OA, grade II-III (mild to moderate) Kellgren Lawrence (K/L).
Body mass index (BMI) from 20 to 30 kg/m2.
Met the American College of Rheumatology clinical criteria for mild to moderate knee OA.
knee pain > 3 cm on a 10 cm visual analog scale (VAS) on most days of the previous week.
Bilateral knee osteoarthritis.
Exclusion Criteria:
Congenital or acquired inflammatory or neurological (systemic or local) diseases involving the knee.
Patients who have mental or cognitive illness that interfere their ability to perform the exercises or the evaluation tests.
Intra articular knee injection of steroids in the past 6 months.
Patients who had received joint replacement surgery in either Knee or hip.
Patients with rheumatoid arthritis.
Patients who received physical therapy sessions on the knee in the past 6 months.
Facility Information:
Facility Name
Faculty of physical therapy Cairo University
City
Giza
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Exercises on Dynamic Balance in Knee Osteoarthritis Patients.
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