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Completed

NCT Number: NCT04587102

Whole Body Vibration Training for Diabetic Patients With Burn Injury

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

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Key information

Conditions

Burn Injury Burns Wounds and Injuries

Age range

40 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zizi Mohammed Ibrahim Ali, Giza, Nnjkjk, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: WBV

Traditional program(balance exercises and resisted exercises)

Other

balance exercises and resisted exercises

Primary outcomes

  1. Dynamic balance assessment

    Time frame: Change from Baseline at balance scores at 8 weeks

    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

Secondary outcomes

  1. The Activities-specific Balance

    Time frame: Change from Baseline at Activities-specific Balance scores at 8 weeks

    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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 14, 2020
Registry last updated
May 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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