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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06110104
Other study ID # knee osteoarthritis patients
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 11, 2023
Est. completion date September 23, 2023

Study information

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

Clinical Trial Summary

Osteoarthritis is one of the most common degenerative joint disease that affects approximately more than 300 million people worldwide


Description:

this study compare the efficacy of Retro-walking program and whole body vibration on quadriceps muscle torque,endurance, Balance and knee functional disability in patients with chronic unilateral knee Osteoarthritis . it has three groups. first group recieves The Routine physiotherapy program comprises a combination of closed kinetic chain and open kinetic chain exercises cause the least intraarticular inflammation, bone destruction, and pressure over the joint. the seconed group recieves routine physiotherapy and Retro-walking which is considered a safe Closed Kinematic Chain exercise since the compressive forces at the patello-femoral joint are reduced. it include improvement in muscle activation pattern, Reduction in adductor moment at knee during stance phase of gait and augmented stretch of hamstring muscle groups during the stride; all of these may have helped in reducing disability thus leading to improved function.It reduces quadriceps eccentric function, while the isometric and concentric quadriceps strength are preserved improved pain relief and aerobic fitness level, without aggravating symptoms following walking programs in patients with knee OA. the third group recieves routine physiotherapy program and Whole-body vibration training which is now a day's got its wider importance, especially in clinical cases. It has a role in maintaining balance, proprioception, blood circulation, and hormone level that enhances the effect on the neuromuscular system . it is a new type of exercise therapy, which mainly improves muscle coordination to optimize joint function .it is performed as a neuromuscular modality in muscle strength training . As it is safe, effective and potentially feasible treatment, WBV training has also been proposed for several musculoskeletal system diseases. the study ethical committee number is NO:P.T.REC/012/004280. the total sample size are 45 (for 3 groups), 45 patients (15 patients per group).


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date September 23, 2023
Est. primary completion date September 11, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 55 Years
Eligibility Inclusion Criteria: - 1.Subjects are required to have a radiograph of the knee joints within 2 weeks of testing. 2.Weight-bearing, fixed flexion radiographs of the knee were taken in the AP views . 3.Radiographic evidence of knee OA.according to Kellgren and Lawrence classification scale (gradeIII) as 0,Normal and 4,Sever. 4.Particepants age are 40-55 . 5.Knee pain for at least 3 month , with pain presenting at least 3 days a week during last month. 6.functional limitations (patients with pain &stiffnes), The Arabic version of the western womac (ArWOMAC) scores (average 37) 7.ability to ambulate independently for at least 10 meters. 8.Ability to follow simple structures. Exclusion Criteria: - 1.(BMI) more = 30. 2.History of knee surgery to knee within past 3 months 3.A systemic arthritic condition. 4.Any other muscular, joint or neurological condition affecting lower limb function. 5.Physical therapy or an intra-articular injection in the knee within the past 3 months. 6.Change in pain medications in the previous month. 7.Healthy participants, impairment conditions unrelated to gait conditions such as cardio- and respiratory-related diseases, people with lower limb amputations, and lower prosthetic limbs.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
routine physiotherapy program for knee osteoarthritis
The Routine physiotherapy program comprises a combination of closed kinetic chain and open kinetic chain exercises, including straight leg raising, isometric quadriceps, isometric hip adduction, terminal knee extension, semi-squat, and leg press for 6 weeks.
Retro-walking program
Retro-walking program is about 10 min of supervised retro walking training 3 days a week for 6 weeks at their comfortable walking speed . The participants will be instructed to gradually increase their walking time up to 30 min over the 6-week period.
whole body vibration training
whole body vibration is 3 days per week for 6 weeks. During the training, the participants will perform static squat training barefoot on the platform with bent knees (30° and 60°). The distance between the feet was consistent with the shoulders. the duration time, sets and total time will be increased progressively over the 6-week.

Locations

Country Name City State
Egypt Faculty of Physical Therapy Cairo

Sponsors (1)

Lead Sponsor Collaborator
Marwa Gamal Abd El Ghany Fathalla

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary quadriceps torque hand-held dynamometer offers a reliable and valid method to quantify quadriceps strength in a clinical environmen .quadriceps peak torque obtained with an HHD is valid compared to an isokinetic dynamometer. it offers a less expensive and time-consuming way to obtain measures in a clinical environment. The torque peak (Nm) of the quadriceps will be measured by multiplying the force, acceleration of gravity and lever arm: [force (kg) × 9.81 × lever arm (m)]. Quadriceps torque (Nm) data were normalized by the body mass (kg) of each participant: torque (Nm)/body mass (kg). 6 weeks
Primary quadriceps endurance Fatigue resistance test assesses Quadriceps isometric endurance .The individuals will sit on a chair with their back straight and their hips and knees flexed at 90 degrees. A 5 kg weight will be secured with tape above the ankle (testing side), and leg alignment In relation to the horizontal plane measured by digital inclinometer.A stopwatch will use to record the time. The duration of time spent in this position is used to determine their knee extensor endurance capacity. If the knee extension position shifted at least five degrees from the horizontal plane , or the participant could not sustain the test leg in a horizontal position due to pain or fatigue, the test will be terminated.This Endurance testing protocol will be repeated three times, and the best effort will be taken for analysis. There is a rest period of three minutes between each testing trial. The same investigator will record the individuals' readings. 6 weeks
Primary balance Balance in knee osteoarthritis will be measured by Time up and go test During the test, all participants were asked to stand up from a chair without armrests and with a seat height of 44 cm, walk at a comfortable pace to a line 3 m away, cross the line and turn through 180°, walk back, and sit in their starting position. The use of an assistive device was allowed for those using one, but no verbal encouragement or personal assistance was given. After one pilot test, the average time of the two successive trials was recorded using a timer with an accuracy of 1/100 s. 6 weeks
Primary knee functional disability Functional disability will be assessed using the Arabic version of the Western Ontario and McMaster Universities Osteoarthritis index.
The pain subscale includes five questions about pain .The stiffness subscale includes two questions about stiffness . The physical function subscale includes 17 questions about the degree of difficulty .Each of the 24 questions is graded either on a five-point Likert scale (0 to 4) or a 100 mm visual analogue scale (VAS)9ranging from 0 (no pain) to 100 (extreme pain).
6 weeks
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