Efficacy of Biodex Balance Training Versus Whole Body Vibration Training in Patients With Knee Osteoarthritis

NCT06563258 | Recruiting FDA Device

• 1 other identifier: P.T.REC/012/005293
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

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.

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. \-

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.

Other: traditional exercises

Interventions

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.

Biodex Balance Training in Patients With Knee Osteoarthritis

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.

Whole Body Vibration Training in Patients With Knee Osteoarthritis

traditional exercises OTHER

1. 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)

Whole Body Vibration Training in Patients With Knee Osteoarthritis; traditional exercises in Patients With Knee Osteoarthritis

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Mti University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

WALAA W.M MOHAMED, master

CONTACT

01024098806; dr-walaamohamed@hotmail.com

WALAA MOHAMED, master

CONTACT

01024098806; dr-walaamohamed@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: A Prospective parallel group single-blind randomized control trial

Study Record Dates

• First Submitted: August 18, 2024
• First Posted: August 20, 2024
• Study Start: September 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

EG (1)