Whole Body Vibration Training for Diabetic Patients With Burn Injury

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

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

Study Overview

• Status: Completed
• Conditions: Burn Injury
• Intervention / Treatment: Other: whole body viberation; Other: Traditional program(balance exercises and resisted exercises)

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

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 2136
    • Burn Unit at Om El Masrien Hospital
  • Nnjkjk
    • Giza, Nnjkjk, Egypt, 2136
      • Zizi Mohammed Ibrahim Ali
• Saudi Arabia
  • Riyadh, Saudi Arabia, 2136
    • Zizi Mohammed Ibrahim Ali

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: whole body viberation :group A; will receive low vibrational training in the form of whole body vibration for 8 weeks	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; Other Names: WBV; Other: Traditional program(balance exercises and resisted exercises); balance exercises and resisted exercises
ACTIVE_COMPARATOR: control group (B); control	Other: Traditional program(balance exercises and resisted exercises); balance exercises and resisted exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: ZIZI MOHAMMED I ALI, Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 10, 2019
• Primary Completion (ACTUAL): September 12, 2020
• Study Completion (ACTUAL): November 20, 2020

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (ACTUAL): October 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 15, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Burns; Wounds and Injuries
• Other Study ID Numbers: VIYOBURN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No