Back to resultsEfficacy of Whole-body Vibration on Balance Control, Postural Stability and Mobility After Thermal Burn Injuries.
Primary Purpose
Thermal Burn
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
whole body vibration device
routine physical therapy treatment
Sponsored by
About this trial
This is an interventional treatment trial for Thermal Burn
Eligibility Criteria
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.
Sites / Locations
- Cairo University, Faculty of physical therapy.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Whole body vibration plus routine physical therapy
Routine physical therapy
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04500314
Brief Title
Efficacy of Whole-body Vibration on Balance Control, Postural Stability and Mobility After Thermal Burn Injuries.
Official Title
Efficacy of Whole-body Vibration on Balance Control, Postural Stability and Mobility After Thermal Burn Injuries. Prospective Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
December 25, 2020 (Actual)
Study Completion Date
December 28, 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
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thermal Burn
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Whole body vibration plus routine physical therapy
Arm Type
Experimental
Arm Title
Routine physical therapy
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
whole body vibration device
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
routine physical therapy treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
Postural stability
Description
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
Time Frame
8 weeks of treatment
Secondary Outcome Measure Information:
Title
Time up and go test
Description
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
Time Frame
8 weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Cairo University, Faculty of physical therapy.
City
Cairo
State/Province
Giza
ZIP/Postal Code
12322
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
after 6 month from the date of publication
IPD Sharing Time Frame
After 6 month of publication.
IPD Sharing Access Criteria
Study protocol. Informed consent form
Learn more about this trial
Efficacy of Whole-body Vibration on Balance Control, Postural Stability and Mobility After Thermal Burn Injuries.
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