Impact of Whole-body Vibration Training on Flexibility, Muscular Activity and Quality of Life After Lower Extremity Thermal Burn Injury

NCT06787716 | Completed DMC

• 1 other identifier: P.T.REC/012/005595
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Tight hamstring muscles limit the anterior tilt of the pelvis in spinal flexion resulting in aggravated muscle and ligamentous tension in the lumbar region which leads to significantly higher compressive loads on the lumbar spine. Other postural changes associated with tightness of the hamstrings can influence the sacroiliac joint stability in an indirect way. Hence, flexibility of hamstring muscles is crucial for overall well-being and optimal physical fitness.

Conditions

Lower Extremity Burns

Keywords

burn; flexibility; EMG; muscular activity; quality of life

Outcome Measures

Primary Outcomes (1)

• Active Knee Extension Test:

  Active knee extension test: The knee extension angle was measured using a standard goniometer. The goniometer was placed at the lateral epicondyle of the femur, with one arm aligned with the femur and the other with the tibia.

  12 weeks

Secondary Outcomes (4)

• Straight Leg Raising Test

  12 weeks

• Electromyography for Quadriceps Muscle

  12 weeks

• Electromyography for Hamstring Muscles

  12 weeks

• The SF-36 questionnaire

  6 months

Study Arms (2)

Whole body vibration group

EXPERIMENTAL

Device: The whole body vibration

Control group

OTHER

Other: The traditional physical therapy program

Interventions

The whole body vibration DEVICE

Patients in the study group will receive the traditional physical therapy program first (passive and active ROM exercises, stretching and strengthening exercises) for 60 minutes, 3 days/ week for 12 weeks.This will be followed immediately by whole-body vibration training on the vibration platform (Power Plate International, Irvine, California, USA) at the same visit. The vibration frequency will be 30 Hz and the amplitude from 4 to 7 mm, with an increase of 1mm every two weeks. The WBV program will be three sessions a week for 12 weeks. WBV duration started with 10 min at the 1st week up to 35 min at the 12th week, with a regular increase of five minutes every two successive weeks.

Whole body vibration group

The traditional physical therapy program OTHER

The traditional physical therapy program will be three days a week for 12 weeks. The program will include 60 minutes of a supervised and individualized exercise program including passive and active exercises of the hip, knee, and ankle joints, stretching exercises for the Calf and hamstring muscles followed by strengthening exercises of the hip, knee, ankle, and foot muscles. To improve the strength, free weights will be used for all exercises. During the first week, 50 to 60% of the repetitions maximum test will be set as the starting weight. Then, from the second week to the sixth, the weight will be increased to 70%-75% of three repetitions maximum (3 sets, 4-10 repetitions). The training amplitude then will be raised to 80%-85% of the three-repetition maximum (3 sets, 8-12 repetitions) that will be continued through weeks 7 to 12, holding 5 seconds at the end of the range.

Control group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with a deep second-degree thermal burn of the lower extremity, 35%-40% total body surface area (TBSA) of burn as measured with the rule of nine, after six weeks from the injury or complete wound healing.
• Patients with 20 to 50 years old.
• Absence of any neurological disorder i.e.: stroke, ataxia, or parkinsonism.

You may not qualify if:

• Patients with open wounds.
• Patients with recent fractures.
• Patients with severe obesity BMI ≥40.
• Patients with cardiorespiratory disorders.
• Patients with bone disease, joint replacement, and traumatic spine history since last year.
• Those subjects who will be eligible to take part in the study will sign an informed consent before participation in the study.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Cairo, Giza Governorate, Egypt

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Physical Therapy

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 22, 2025
• Study Start: January 20, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

EG (1)