Knee OsteoarthritisNCT06563258
Efficacy of Biodex Balance Training Versus Whole Body Vibration Training in Patients With Knee Osteoarthritis
A study testing Biodex Balance Training, A vibration device and traditional exercises in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to answer the research question: Are there differences between the effect of Biodex balance training and Whole-body vibration training on Knee osteoarthritis? Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Biodex Balance Training, A vibration device and traditional exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 30 Mar 2025
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects age between (40-60) years old.
- Radiologic findings had to be compatible with knee OA grade 2 in a simple X ray.
- Tenderness on medial tibial plateau
- Intensity of pain: visual analogue scale equal to 5 or greater
- Failure of two or more types of previous conservative treatment (medication, anti-inflammatory drugs, physical therapy, stretching, acupuncture, orthotics and others) in the last three months
Who cannot join
- Neurological and vestibular system disorder, systematic inflammatory disease, steroid injections in the last six months
- Subjects with diabetes mellitus.
- acute symptomatic arthritis
- other conditions (such as osteomyelitis, tuberculosis, and tumor) that affect their walking function; had a contraindication to exercise; and exhibited cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
This study will be conducted to answer the research question:
Are there differences between the effect of Biodex balance training and Whole-body vibration training on Knee osteoarthritis?
Read the detailed description
The purpose of this study is to compare the effects of biodex training balance versus whole body vibration training on Knee osteoarthritis on:
- Pain intensity
- static balance
- dynamic balance
- Functional ability level
- Conditions
- Knee Osteoarthritis
- Being tested
- Biodex Balance Training, A vibration device, traditional exercises
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodex Balance TrainingDevice
Sixty Subjects of both genders aged 40-60 years old with grade 2 knee osteoarthritis years will diagnosed by orthopedists they will assigned randomly into three groups:
- Group A Will receive WBV Training with frequency of 35 Hz, peak-to-peak amplitude of 4- to 6-mm Vertical sinusoidal vibration, and the total exposure time of 30 minutes (vibration 60 seconds, interval rest 60 seconds) in addition to traditional exercises,3 sessions per week for four weeks. , A vibration device (My7™ model Personal Plate, Power Plate, Northbrook, IL, USA) will used in all WBVT sessions.
- Group B will receive Biobex training and traditional exercises Total time of training was 10 minutes each set is 3 minutes with 20-second rest intervals
- Group C Patients will receive only traditional exercises, 3 sessions per week for four weeks. a good general guideline is 2-3 sets of 10-15 repetitions for each exercise.
A vibration deviceDevice
WBV Training with frequency of 35 Hz, peak-to-peak amplitude of 4- to 6-mm Vertical sinusoidal vibration, and the total exposure time of 30 minutes (vibration 60 seconds, interval rest 60 seconds) in addition to traditional exercises,3 sessions per week for four weeks. , A vibration device (My7™ model Personal Plate, Power Plate, Northbrook, IL, USA) will used in all WBVT sessions.
traditional exercisesOther
- Stretch exercises (flexibility exercise) Rectus femoris, Iliotibial band, Hamstring and self-stretch for calf muscle (3sets, each stretch 30 sec hold, between each set 5sec rests).
- Strengthen exercises(resistance exercise)
- Isometric Exercises for quadriceps (10 rep,3sets)
- Hip abductors strengthening 45 degree (10 rep,3sets)
- Hip extensor strengthening 15 degree (10 rep,3sets)
- Straight leg raising 45-70 degree (10 rep,3sets)
- Short arc knee extension (10 rep,3sets)
| Study group | Role | What they receive |
|---|---|---|
| Whole Body Vibration Training in Patients With Knee Osteoarthritis | Experimental | Group A Will receive WBV Training with frequency of 35 Hz, peak-to-peak amplitude of 4- to 6-mm Vertical sinusoidal vibration, and the total exposure time of 30 minutes (vibration 60 seconds, interval rest 60 seconds) in addition to traditional exercises,3 sessions per week for four weeks. Receives: Device: A vibration device; Other: traditional exercises |
| Biodex Balance Training in Patients With Knee Osteoarthritis | Experimental | Group B will receive Biobex training, Total time of training was 10 minutes each set is 3 minutes with 20-second rest intervals in addition to traditional exercises,3 sessions per week for four weeks.
- Receives: Device: Biodex Balance Training |
| traditional exercises in Patients With Knee Osteoarthritis | Experimental | Group C Patients will receive only traditional exercises, 3 sessions per week for four weeks. a good general guideline is 2-3 sets of 10-15 repetitions for each exercise. Receives: Other: traditional exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be measured by visual analogue scale (VAS),patients were presented with a 10-cm horizontal line, where the left end represents "no pain" and the right end represents "worst imaginable pain.
Measured: one month
static balance
static balance will be measured by Postural stability test by Biodex balance SD.
Measured: one month
Dynamic balance
Dynamic balance will be measured by Limit of stability Test by biodex balance SD.
Measured: one month
.Functional abilities
Functional abilities will be measured by Arabic- language version of knee injury and osteoarthritis outcome score physical function short form (KOOS-PS).This validated seven-item questionnaire evaluates physical function in activities of daily living, with scores ranging from 0 (no disability) to 100 (severe disability)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Sep 2024
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- A Prospective parallel group single-blind randomized control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, walaa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563258
- Sponsor's protocol ID
- P.T.REC/012/005293
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Biodex Balance Training Versus Whole Body Vibration Training in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06563258
- Acronym / sponsor ID
- P.T.REC/012/005293
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 20 Aug 2024 (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.
This study will be conducted to answer the research question:
Are there differences between the effect of Biodex balance training and Whole-body vibration training on Knee osteoarthritis?
Detailed description
The purpose of this study is to compare the effects of biodex training balance versus whole body vibration training on Knee osteoarthritis on:
- Pain intensity
- static balance
- dynamic balance
- Functional ability level
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- A Prospective parallel group single-blind randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Whole Body Vibration Training in Patients With Knee Osteoarthritis | Experimental | Device: A vibration device, Other: traditional exercisesGroup A Will receive WBV Training with frequency of 35 Hz, peak-to-peak amplitude of 4- to 6-mm Vertical sinusoidal vibration, and the total exposure time of 30 minutes (vibration 60 seconds, interval rest 60 seconds) in addition to traditional exercises,3 sessions per week for four weeks. |
| Biodex Balance Training in Patients With Knee Osteoarthritis | Experimental | Device: Biodex Balance TrainingGroup B will receive Biobex training, Total time of training was 10 minutes each set is 3 minutes with 20-second rest intervals in addition to traditional exercises,3 sessions per week for four weeks. - |
| traditional exercises in Patients With Knee Osteoarthritis | Experimental | Other: traditional exercisesGroup C Patients will receive only traditional exercises, 3 sessions per week for four weeks. a good general guideline is 2-3 sets of 10-15 repetitions for each exercise. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects age between (40-60) years old.
- Radiologic findings had to be compatible with knee OA grade 2 in a simple X ray.
- Tenderness on medial tibial plateau
- Intensity of pain: visual analogue scale equal to 5 or greater
- Failure of two or more types of previous conservative treatment (medication, anti-inflammatory drugs, physical therapy, stretching, acupuncture, orthotics and others) in the last three months
Key exclusion criteria (4 listed)
- Neurological and vestibular system disorder, systematic inflammatory disease, steroid injections in the last six months
- Subjects with diabetes mellitus.
- acute symptomatic arthritis
- other conditions (such as osteomyelitis, tuberculosis, and tumor) that affect their walking function; had a contraindication to exercise; and exhibited cognitive impairment
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 |
|---|---|---|
| Biodex Balance TrainingSixty Subjects of both genders aged 40-60 years old with grade 2 knee osteoarthritis years will diagnosed by orthopedists they will assigned randomly into three groups: * Group A Will receive WBV Training with frequency of 35 Hz, peak-to-peak amplitude of 4- to 6-mm Vertical sinusoidal vibration, and the total exposure time of 30 minutes (vibration 60 seconds, interval rest 60 seconds) in addition to traditional exercises,3 sessions per week for four weeks. , A vibration device (My7™ model Personal Plate, Power Plate, Northbrook, IL, USA) will used in all WBVT sessions. * Group B will receive Biobex training and traditional exercises Total time of training was 10 minutes each set is 3 minutes with 20-second rest intervals * Group C Patients will receive only traditional exercises, 3 sessions per week for four weeks. a good general guideline is 2-3 sets of 10-15 repetitions for each exercise. | Device | Biodex Balance Training in Patients With Knee Osteoarthritis |
| A vibration deviceWBV Training with frequency of 35 Hz, peak-to-peak amplitude of 4- to 6-mm Vertical sinusoidal vibration, and the total exposure time of 30 minutes (vibration 60 seconds, interval rest 60 seconds) in addition to traditional exercises,3 sessions per week for four weeks. , A vibration device (My7™ model Personal Plate, Power Plate, Northbrook, IL, USA) will used in all WBVT sessions. | Device | Whole Body Vibration Training in Patients With Knee Osteoarthritis |
| traditional exercises1. Stretch exercises (flexibility exercise) Rectus femoris, Iliotibial band, Hamstring and self-stretch for calf muscle (3sets, each stretch 30 sec hold, between each set 5sec rests). 2. Strengthen exercises(resistance exercise) 1. Isometric Exercises for quadriceps (10 rep,3sets) 2. Hip abductors strengthening 45 degree (10 rep,3sets) 3. Hip extensor strengthening 15 degree (10 rep,3sets) 4. Straight leg raising 45-70 degree (10 rep,3sets) 5. Short arc knee extension (10 rep,3sets) | Other | Whole Body Vibration Training in Patients With Knee Osteoarthritis, traditional exercises in Patients With Knee Osteoarthritis |
Primary outcome
Pain intensity
Time frame: one month
Pain intensity will be measured by visual analogue scale (VAS),patients were presented with a 10-cm horizontal line, where the left end represents "no pain" and the right end represents "worst imaginable pain.
static balance
Time frame: one month
static balance will be measured by Postural stability test by Biodex balance SD.
Dynamic balance
Time frame: one month
Dynamic balance will be measured by Limit of stability Test by biodex balance SD.
.Functional abilities
Time frame: one month
Functional abilities will be measured by Arabic- language version of knee injury and osteoarthritis outcome score physical function short form (KOOS-PS).This validated seven-item questionnaire evaluates physical function in activities of daily living, with scores ranging from 0 (no disability) to 100 (severe disability)
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 25 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biodex Balance Training, A vibration device and traditional exercises in people with Knee Osteoarthritis, run by Cairo University 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 4 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 25 Aug 2026. 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?
Pain intensity (time frame: one month). 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 25 Aug 2026.