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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05941117
Other study ID # P.T.REC/012/003919
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 25, 2022
Est. completion date June 15, 2023

Study information

Verified date July 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date June 15, 2023
Est. primary completion date June 15, 2023
Accepts healthy volunteers No
Gender All
Age group 50 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.
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.

Locations

Country Name City State
Egypt Faculty of physical therapy Cairo University Giza

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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