Effect of Exercises on Dynamic Balance in Knee Osteoarthritis Patients.

Effect of Weight Bearing Versus Non-weight Bearing Strengthening Exercises on Dynamic Balance in Knee Osteoarthritis Patients.

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Combination product: stretching exercises; Combination product: Transcutaneous electrical nerve stimulation; Combination product: weight bearing strengthening exercises; Combination product: Non-weight bearing strengthening exercises

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Faculty of Physical Therapy Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: weight bearing exercises group; 20 patients were assigned to this group with bilateral knees osteoarthritis, they received TENS, stretching exercises and weight bearing strengthening exercises.	Combination product: stretching exercises; 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.; Combination product: Transcutaneous electrical nerve stimulation; it is one of the electrical stimulation modalities which is used to relief pain, each patient receive it on both knees every session.; Other Names: TENS; Combination product: weight bearing strengthening exercises; 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.
Active Comparator: non-weight bearing exercises group; 20 patients were assigned to this group with bilateral knees osteoarthritis, they received TENS, stretching exercises and Non-weight bearing strengthening exercises.	Combination product: stretching exercises; 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.; Combination product: Transcutaneous electrical nerve stimulation; it is one of the electrical stimulation modalities which is used to relief pain, each patient receive it on both knees every session.; Other Names: TENS; Combination product: Non-weight bearing strengthening exercises; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one day after the end of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one day after the end of treatment
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.	one day after the end of treatment

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Actual): June 15, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: June 25, 2023
• First Submitted That Met QC Criteria: July 9, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 9, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: P.T.REC/012/003919

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No