Efficacy of Whole-body Vibration on Balance Control, Postural Stability and Mobility After Thermal Burn Injuries.

Thermal Burn Clinical Trial

Official title:

Efficacy of Whole-body Vibration on Balance Control, Postural Stability and Mobility After Thermal Burn Injuries. Prospective Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04500314
• Other study ID #: 182020
• Status: Completed
• Phase: N/A
• Start date: August 5, 2020
• Est. completion date: December 28, 2020

Study information

• Verified date: March 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be conducted to investigate the effect of whole-body vibration device on Balance control, postural Stability and mobility after thermal burn injuries.

Description:

40 patients with deep second-degree burn involving the lower limbs and trunk (TBSA: 35-40%), will be randomly assigned either into the experimental group, received whole body vibration (WBV) plus the routine physical therapy program or the control group, received the same routine physical therapy program. All treatment interventions will be applied at a frequency of three sessions per week for 8 weeks. Anteroposterior stability (APS), Medial lateral stability (MLS), Time up and go test (TUG) test, and Berg balance scale will be the outcome measures of the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 28, 2020
• Est. primary completion date: December 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Age ranged between 20 and 45 years,
• Deep 2nd degree of thermal burn of lower limb and trunk with (35-40%) surface area of burn as measured by "rule of nine" method, with complete wound healing or after 6 weeks from the injury.
• Body mass index of between 17 and 35, with no history of neurological disorders or injuries to the lower extremities.

Exclusion Criteria:

• Patients with open burn wound,
• Patients diagnosed with acute rheumatoid arthritis,
• Joint replacement within the past year,
• History of traumatic spine within the past six months,
• Prosthesis,
• Recent fracture or bone disease.

Related Conditions & MeSH terms

• Burns
• Thermal Burn

Intervention

Device:
• whole body vibration device
20 patients will receive vibration training on vibration platform (Power Plate International, Irvine, California, USA) at a frequency of 25-30 Hz and amplitude of 3-5mm, plus traditional physical therapy program 3 sessions per week for total period of 8 weeks. The total duration of the WBV training stimulus will 10 min in first week and progress gradually to 25 min in the 8th week with regular increase by 5 minutes after each 2 successive weeks

Other:
• routine physical therapy treatment
The program consists of 60 minutes supervised and individualized stretching exercise to all involved muscles followed by strengthening for affected muscles, mobilizing exercise for the joints involved to increase the joint range of motion, in addition to scar management techniques including pressure garments, inserts, and physical agent modalities , to avoid scar or contracture formation

Locations

Country	Name	City	State
Egypt	Cairo University, Faculty of physical therapy.	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postural stability	The antero-posterior stability index (APSI) was measured for all cases before and after eight weeks of treatment. This index will be standard deviations assessing fluctuations around the zero point (horizontal) rather than around a group mean. The APSI assessed the fluctuations from the horizontal along the AP on the BSS	8 weeks of treatment
Secondary	Time up and go test	The TUG test used to measure mobility. Participants were asked to raise up from sitting in a chair to a standing position and to walk a distance of 3 m, turn around, walk back to the chair, and sit down again with their backs flush to the back of the chair and with arms resting on the arm rests. The time for participants to complete the task was measured in seconds with a stopwatch. The best, or lowest time from 3 trials, was used in the analysis	8 weeks of treatment