Whole Body Vibration Training for Diabetic Patients With Burn Injury

NCT ID: NCT04587102

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-10
• Study Completion Date: 2020-11-20

Brief Summary

Burn injury as well as diabetes mellitus (DM) induce physical functional and psychological impairments. Lower limb burn involving Foot are still a challenging heath condition because of its important sensory role. Balance is disturbed either in patients with lower limb burn injury or diabetic patients. This study aime to compare between the effects whole body vibrational training and Yoga exercises on postural balance, and Activities-specific Balance Confidence in in type II diabetic Patients with foot burn

Detailed Description

Thirty eight diabetic patients (17 male, 21female) with foot burn injury, with their age ranged from 40 to 55 years. They will randomly assigned into two equal groups. Group (A) will receive low vibrational training in the form of whole body vibration for 8 weeks (n=19), while group (B) the control group for 8 weeks (n=19) in addition both groups will receive their routine medical care and physical therapy rehabilitation including balancing exercises. Dynamic balance will be evaluated through Biodex balance system (BBS);and balance confidence will be measured by the Activities-specific Balance Confidence Scale (ABC) before the starting and after the end of treatment for all patients in both groups

Conditions

Burn Injury

Study Design

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

Study Groups

whole body viberation :group A

will receive low vibrational training in the form of whole body vibration for 8 weeks

Group Type: ACTIVE_COMPARATOR

whole body viberation

Intervention Type: OTHER

vibration training in the form of whole body vibration for 20-30 minutes per session, 3 sessions per week for 8 weeks. The vibration training was performed on a whole body vibration platform

Traditional program(balance exercises and resisted exercises)

Intervention Type: OTHER

balance exercises and resisted exercises

control group (B)

control

Group Type: ACTIVE_COMPARATOR

Traditional program(balance exercises and resisted exercises)

Intervention Type: OTHER

balance exercises and resisted exercises

Interventions

whole body viberation

vibration training in the form of whole body vibration for 20-30 minutes per session, 3 sessions per week for 8 weeks. The vibration training was performed on a whole body vibration platform

Intervention Type: OTHER

Traditional program(balance exercises and resisted exercises)

balance exercises and resisted exercises

Intervention Type: OTHER

Other Intervention Names

WBV

Eligibility Criteria

Inclusion Criteria

• chronic lower limb burns injury for more than 6 months
• Total body surface area (TBSA) burnt ≤ 30%.;

Exclusion Criteria

• cognitive or mentality dysfunctions,
• psychiatric conditions,
• fractures,
• pregnancy,
• cancer,
• severe vascular complications,
• inability to walk

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

ZIZI MOHAMMED IBRAHIM ALI

Assistant Professor of physical therapy, Department of Physical Therapy for Burn and Plastic Surgery, Faculty of Physical Therapy, Cairo University, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ZIZI MOHAMMED I ALI

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Zizi Mohammed Ibrahim Ali

Giza, Nnjkjk, Egypt

Burn Unit at Om El Masrien Hospital

Giza, , Egypt

Zizi Mohammed Ibrahim Ali

Riyadh, , Saudi Arabia

Countries

Egypt; Saudi Arabia

Other Identifiers

VIYOBURN

Identifier Type: -

Identifier Source: org_study_id