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: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: A vibration device; Other: traditional exercises; Device: Biodex Balance Training

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: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: WALAA W.M MOHAMED, master; Phone Number: 01024098806; Email: dr-walaamohamed@hotmail.com
• Study Contact Backup: Name: WALAA MOHAMED, master; Phone Number: 01024098806; Email: dr-walaamohamed@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • MTI University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria:

1. Subjects age between (40-60) years old.
2. Radiologic findings had to be compatible with knee OA grade 2 in a simple X ray.
3. Tenderness on medial tibial plateau
4. Intensity of pain: visual analogue scale equal to 5 or greater
5. 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:

1. Neurological and vestibular system disorder, systematic inflammatory disease, steroid injections in the last six months
2. Subjects with diabetes mellitus.
3. acute symptomatic arthritis
4. 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

Number of Arms

3

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.	Device: A vibration device; 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.; Other: traditional exercises; 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)
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. -	Device: Biodex Balance Training; 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.
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.	Other: traditional exercises; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Pain intensity will be measured by visual analogue scale (VAS).	one month
static balance	static balance will be measured by Postural stability test by Biodex balance SD.	one month
Dynamic balance	Dynamic balance will be measured by Limit of stability Test by biodex balance SD.	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).	one month

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: August 18, 2024
• First Submitted That Met QC Criteria: August 18, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): August 20, 2024
• Last Update Submitted That Met QC Criteria: August 18, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: P.T.REC/012/005293

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes