Effect of Retrowalking Program Versus Whole Body Vibration in Patients With Chronic Knee Osteoarthritis

October 26, 2023 updated by: Marwa Gamal Abd El Ghany Fathalla

Effect of Retrowalking Program Versus Whole Body Vibration on Quadriceps Muscle Torque in Patients With Chronic Knee Osteoarthritis

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12462
        • Faculty of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: control group
they recieve 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.
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.
Experimental: Retro-walking group
they recieve routine physiotherapy and Retro-walking program which 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.
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.
Other: 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.
Experimental: whole body vibration group
they recieve routine physiotherapy and whole body vibration which 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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
quadriceps torque
Time Frame: 6 weeks
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
quadriceps endurance
Time Frame: 6 weeks
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
balance
Time Frame: 6 weeks
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
knee functional disability
Time Frame: 6 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marwa Gamal Abd El Ghany Fathalla

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: manal mo ismail, PHD, Cairo University
  • Study Director: sara mo samir, MSc, Cairo University
  • Study Director: Ahmed om abd el naem, MSc, faculty of physical therapy cairouniversity
  • Principal Investigator: marwa ga amr, BSc, Faculty of Physical Therapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 11, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • knee osteoarthritis patients

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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