- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06563258
Efficacy of Biodex Balance Training Versus Whole Body Vibration Training in Patients With Knee Osteoarthritis
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?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- MTI University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Whole Body Vibration Training in Patients With Knee Osteoarthritis
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.
|
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.
|
|
Experimental: Biodex Balance Training in Patients With Knee Osteoarthritis
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. - |
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:
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Experimental: traditional exercises in Patients With Knee Osteoarthritis
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
static balance
Time Frame: one month
|
static balance will be measured by Postural stability test by Biodex balance SD.
|
one month
|
|
Dynamic balance
Time Frame: one month
|
Dynamic balance will be measured by Limit of stability Test by biodex balance SD.
|
one month
|
|
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.
|
one month
|
|
.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)
|
one month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005293
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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