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NCT Number: 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?

Recruiting

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Key information

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mti University

Cairo, Egypt

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biodex Balance Training

Device

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 device

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.

Traditional exercises

Other
  • 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)

Primary outcomes

  1. Pain intensity

    Time frame: one month

    Pain intensity will be measured by visual analogue scale (VAS).

  2. static balance

    Time frame: one month

    static balance will be measured by Postural stability test by Biodex balance SD.

  3. Dynamic balance

    Time frame: one month

    Dynamic balance will be measured by Limit of stability Test by biodex balance SD.

  4. .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).

Study contacts

Contact information is provided by the study sponsor or research team.

WALAA MOHAMED, master

CONTACT

[email protected]

01024098806

WALAA W.M MOHAMED, master

CONTACT

[email protected]

01024098806

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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