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

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04500314
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.8
• Patients Per Site Per Month: 8.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Thermal Burn	Device: whole body vibration device; Other: routine physical therapy treatment	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Efficacy of Whole-body Vibration on Balance Control, Postural Stability and Mobility After Thermal Burn Injuries. Prospective Randomized Controlled Trial.
• Actual Study Start Date: Aug 5, 2020
• Actual Primary Completion Date: Dec 25, 2020
• Actual Study Completion Date: Dec 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Whole body vibration plus routine physical therapy	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
Active Comparator: Routine physical therapy	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

Outcome Measures

Primary Outcome Measures

1. Postural stability [8 weeks of treatment]

   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

1. Time up and go test [8 weeks of treatment]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University, Faculty of physical therapy.	Cairo	Giza	Egypt	12322

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hadaya Mosaad, Lecturer, department of physical therapy for surgery, Faculty of Physical Therapy , Cairo university., Cairo University
• ClinicalTrials.gov Identifier: NCT04500314
• Other Study ID Numbers: 182020
• First Posted: Aug 5, 2020
• Last Update Posted: Mar 17, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Burns

Study Results

No Results Posted as of Mar 17, 2021