Whole Body Vibration Training for Diabetic Patients With Burn Injury
Primary Purpose
Burn Injury
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
whole body viberation
Traditional program(balance exercises and resisted exercises)
Sponsored by
About this trial
This is an interventional treatment trial for Burn Injury
Eligibility Criteria
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
Sites / Locations
- Zizi Mohammed Ibrahim Ali
- Burn Unit at Om El Masrien Hospital
- Zizi Mohammed Ibrahim Ali
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
whole body viberation :group A
control group (B)
Arm Description
will receive low vibrational training in the form of whole body vibration for 8 weeks
control
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04587102
Brief Title
Whole Body Vibration Training for Diabetic Patients With Burn Injury
Official Title
Whole Body Vibration Training for Diabetic Patients With Burn Injury: RCT
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
September 12, 2020 (Actual)
Study Completion Date
November 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
whole body viberation :group A
Arm Type
Active Comparator
Arm Description
will receive low vibrational training in the form of whole body vibration for 8 weeks
Arm Title
control group (B)
Arm Type
Active Comparator
Arm Description
control
Intervention Type
Other
Intervention Name(s)
whole body viberation
Other Intervention Name(s)
WBV
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Traditional program(balance exercises and resisted exercises)
Intervention Description
balance exercises and resisted exercises
Primary Outcome Measure Information:
Title
Dynamic balance assessment
Description
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
Time Frame
Change from Baseline at balance scores at 8 weeks
Secondary Outcome Measure Information:
Title
The Activities-specific Balance
Description
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
Time Frame
Change from Baseline at Activities-specific Balance scores at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ZIZI MOHAMMED I ALI
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zizi Mohammed Ibrahim Ali
City
Giza
State/Province
Nnjkjk
ZIP/Postal Code
2136
Country
Egypt
Facility Name
Burn Unit at Om El Masrien Hospital
City
Giza
ZIP/Postal Code
2136
Country
Egypt
Facility Name
Zizi Mohammed Ibrahim Ali
City
Riyadh
ZIP/Postal Code
2136
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Whole Body Vibration Training for Diabetic Patients With Burn Injury
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