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

NCT04500314 | Completed

• 1 other identifier: 182020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Thermal Burn

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time up and go test

  8 weeks of treatment

Study Arms (2)

Whole body vibration plus routine physical therapy

EXPERIMENTAL

Device: whole body vibration device; Other: routine physical therapy treatment

Routine physical therapy

ACTIVE COMPARATOR

Other: routine physical therapy treatment

Interventions

whole body vibration device 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

Whole body vibration plus routine physical therapy

routine physical therapy treatment OTHER

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

Routine physical therapy; Whole body vibration plus routine physical therapy

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University, Faculty of physical therapy.

Cairo, Giza Governorate, 12322, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, department of physical therapy for surgery, Faculty of Physical Therapy , Cairo university.

Study Record Dates

• First Submitted: July 26, 2020
• First Posted: August 5, 2020
• Study Start: August 5, 2020
• Primary Completion: December 25, 2020
• Study Completion: December 28, 2020
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After 6 month of publication.
• Access Criteria: Study protocol. Informed consent form

Locations

EG (1)