Whole Body Vibration Training for Diabetic Patients With Burn Injury

Burn Injury Clinical Trial

Official title:

Whole Body Vibration Training for Diabetic Patients With Burn Injury: RCT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04587102
• Other study ID #: VIYOBURN
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: November 20, 2020

Study information

• Verified date: May 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: November 20, 2020
• Est. primary completion date: September 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Injury
• Burns
• Wounds and Injuries

Intervention

Other:
• 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
• Traditional program(balance exercises and resisted exercises)
balance exercises and resisted exercises

Locations

Country	Name	City	State
Egypt	Burn Unit at Om El Masrien Hospital	Giza
Egypt	Zizi Mohammed Ibrahim Ali	Giza	Nnjkjk
Saudi Arabia	Zizi Mohammed Ibrahim Ali	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Countries where clinical trial is conducted

Egypt,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic balance assessment	Biodex Balance System was used to measure the dynamic balance of each patient in both groups (A and B) before and after 8 weeks of treatment.; The system has a movable balance platform that permits about 20? tilt in 360? range, and is interfaced with computer software for objective balance assessment. It measures the ability of the patient to control the platform's tilting angle, which is quantified as a variation from the center, as well as the deflection degree over time at different stability levels	Change from Baseline at balance scores at 8 weeks
Secondary	The Activities-specific Balance	A short,six-question version of the Activities-specific Balance scale, the Activities-specific Balance scale. Individuals report their balance confidence in six tasks: standing on tiptoes and reaching for something overhead, standing on a chair to reach for something, being bumped into by people while walking through a mall, stepping off an escalator holding onto the railing, stepping off an escalator without holding onto the railing, and walking on an icy sidewalk ABC scores range between 0% and 100%, with higher scores indicating better balance confidence	Change from Baseline at Activities-specific Balance scores at 8 weeks