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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04587102
Other study ID # VIYOBURN
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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