Whole Body Vibration Training for Diabetic Patients With Burn Injury

NCT04587102 | Completed

• 1 other identifier: VIYOBURN
• Study Type: interventional
• Target: 38
• Locations: 2 countries
• Sites: 3

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

Conditions

Burn Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The Activities-specific Balance

  Change from Baseline at Activities-specific Balance scores at 8 weeks

Study Arms (2)

whole body viberation :group A

ACTIVE COMPARATOR

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

Other: whole body viberation; Other: Traditional program(balance exercises and resisted exercises)

control group (B)

ACTIVE COMPARATOR

control

Other: Traditional program(balance exercises and resisted exercises)

Interventions

whole body viberation 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

Also known as: WBV

whole body viberation :group A

Traditional program(balance exercises and resisted exercises) OTHER

balance exercises and resisted exercises

control group (B); whole body viberation :group A

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (3)

Zizi Mohammed Ibrahim Ali

Giza, Nnjkjk, 2136, Egypt

Location

Burn Unit at Om El Masrien Hospital

Giza, 2136, Egypt

Location

Zizi Mohammed Ibrahim Ali

Riyadh, 2136, Saudi Arabia

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• ZIZI MOHAMMED I ALI

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of physical therapy, Department of Physical Therapy for Burn and Plastic Surgery, Faculty of Physical Therapy, Cairo University, Egypt.

Model Details: vibration Group (A) will receive low vibrational training in the form of whole body vibration for 8 weeks , while group B is the control, both groups will receive their routine medical care and physical therapy rehabilitation.

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: October 14, 2020
• Study Start: January 10, 2019
• Primary Completion: September 12, 2020
• Study Completion: November 20, 2020
• Last Updated: May 19, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2); SA (1)