Knee OsteoarthritisNCT06110104
Effect of Retrowalking Program Versus Whole Body Vibration in Patients With Chronic Knee Osteoarthritis
A study testing routine physiotherapy program for knee osteoarthritis, Retro-walking program and whole body vibration training in people with Knee Osteoarthritis, run by Marwa Gamal Abd El Ghany Fathalla at 1 site in Egypt.
Trial summary
Osteoarthritis is one of the most common degenerative joint disease that affects approximately more than 300 million people worldwide Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- routine physiotherapy program for knee osteoarthritis, Retro-walking program and whole body vibration training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Sep 2023to 23 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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).
- Conditions
- Knee Osteoarthritis
- Being tested
- routine physiotherapy program for knee osteoarthritis, Retro-walking program, whole body vibration training
- Keywords
- quadriceps torque,quadriceps endurance,balance,funcitional disability.
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
routine physiotherapy program for knee osteoarthritisOther
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 programOther
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 trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | 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. Receives: Other: routine physiotherapy program for knee osteoarthritis |
| Retro-walking group | Experimental | 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. Receives: Other: routine physiotherapy program for knee osteoarthritis; Other: Retro-walking program |
| whole body vibration group | Experimental | 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. Receives: Other: routine physiotherapy program for knee osteoarthritis; Other: whole body vibration training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
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.
Measured: 6 weeks
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.
Measured: 6 weeks
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).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start11 Sep 2023
- Primary completion11 Sep 2023
- Study completion23 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- interventions; the first intervention: 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. the other intervention : 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. the last intervention is 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marwa Gamal Abd El Ghany Fathalla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marwa Gamal Abd El Ghany Fathalla, Cairo University
- Investigators
- manal mo ismail, PHD, Study chair, Cairo Universitysara mo samir, MSc, Study director, Cairo UniversityAhmed om abd el naem, MSc, Study director, faculty of physical therapy cairouniversitymarwa ga amr, BSc, Principal investigator, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110104
- Sponsor's protocol ID
- knee osteoarthritis patients
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Retrowalking Program Versus Whole Body Vibration on Quadriceps Muscle Torque in Patients With Chronic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06110104
- Acronym / sponsor ID
- knee osteoarthritis patients
- Conditions
- Knee Osteoarthritis
- Keywords
- quadriceps torque,quadriceps endurance,balance,funcitional disability.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Marwa Gamal Abd El Ghany FathallaUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 23 Sep 2023 (actual)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis is one of the most common degenerative joint disease that affects approximately more than 300 million people worldwide
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- interventions; the first intervention: 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. the other intervention : 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. the last intervention is 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.
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Other: routine physiotherapy program for knee osteoarthritisthey 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. |
| Retro-walking group | Experimental | Other: routine physiotherapy program for knee osteoarthritis, Other: Retro-walking programthey 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. |
| whole body vibration group | Experimental | Other: routine physiotherapy program for knee osteoarthritis, Other: whole body vibration trainingthey 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. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| routine physiotherapy program for knee osteoarthritisThe 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 group, control group, whole body vibration group |
| Retro-walking programRetro-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. | Other | Retro-walking group |
| whole body vibration trainingwhole 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. | Other | whole body vibration group |
Primary outcome
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).
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
manal mo ismail, PHD study chair
Cairo University
sara mo samir, MSc study director
Cairo University
Ahmed om abd el naem, MSc study director
faculty of physical therapy cairouniversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing routine physiotherapy program for knee osteoarthritis, Retro-walking program and whole body vibration training in people with Knee Osteoarthritis, run by Marwa Gamal Abd El Ghany Fathalla at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quadriceps torque (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.