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Whole Body Vibration Training for Diabetic Patients With Burn Injury

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04587102
Enrollment
38
Registered
2020-10-14
Start date
2019-01-10
Completion date
2020-11-20
Last updated
2021-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn Injury

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

Interventions

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

OTHERTraditional program(balance exercises and resisted exercises)

balance exercises and resisted exercises

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
40 Years to 55 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dynamic balance assessmentChange from Baseline at balance scores at 8 weeksBiodex 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

MeasureTime frameDescription
The Activities-specific BalanceChange from Baseline at Activities-specific Balance scores at 8 weeksA 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

Countries

Egypt, Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026