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

NCT ID: NCT06563258

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-03-30

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?

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

A vibration device

Intervention Type: 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

Intervention Type: 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)

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.

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Group Type: EXPERIMENTAL

Biodex Balance Training

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

traditional exercises

Intervention Type: 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)

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

traditional exercises

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)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

walaa

assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mti University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

WALAA W.M MOHAMED, master

Role: CONTACT

dr-walaamohamed@hotmail.com

01024098806

WALAA MOHAMED, master

Role: CONTACT

dr-walaamohamed@hotmail.com

01024098806

Other Identifiers

P.T.REC/012/005293

Identifier Type: -

Identifier Source: org_study_id