NCT06473311

Brief Summary

Burns are injuries that can have both local and systemic effects and are brought on by biological, chemical, electrical, and physical factors. Mobility is a significant problem for burn patients in terms of their quality of life since the burn injury affects their capacity to participate in activities of daily living. The immobility of the patient has a major impact on their physical health. The aim of current study was to compare between the effect of virtual reality and whole body vibration as two methods of proprioceptive stimulation on quadriceps strength and activity of daily living in children with burn.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 13, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

1 month

First QC Date

June 13, 2024

Last Update Submit

June 22, 2024

Conditions

Keywords

Burnproprioceptive stimulationWhole body vibrationVirtual realityActivity of daily living

Outcome Measures

Primary Outcomes (2)

  • quadriceps strength

    measurement of quadriceps power by Baseline Economy Mechanical Push/Pull

    2 months

  • activities of daily living

    measurement od ADL by Physical Self Maintenance Scale. the score is 1 and zero the better score is 1

    2 MONTHS

Study Arms (2)

whole body vibration

EXPERIMENTAL
Device: whole bady vibration and virtual reality

virtual reality

EXPERIMENTAL
Device: whole bady vibration and virtual reality

Interventions

study group I received a whole body vibration program in addition to a conventional physical therapy program, and study group II received a Wii-fit therapy program (a virtual reality treatment program) in addition to the same. A two-month treatment program was implemented for both groups. Every child in both groups had the same evaluation processes, which included using the Physical Self Maintenance Scale (PSMS) for daily living activities and a dynamometer to measure quadriceps muscular strength. Evaluation was done prior to the start of treatment and was done again after one month (post I) and two months (post II).

virtual realitywhole body vibration

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Both sexes were included
  • Children with unilateral front thigh thermal burn of deep partial thickness of dermis (second degree) burns
  • Their ages ranged from 6 to 12 years, d) They can assume standing position

You may not qualify if:

  • st, 3rd and 4th degrees of burn
  • Other types of burn rather than thermal
  • Neurological or neuromuscular disorders
  • Dermatological disorders
  • Visual or hearing disorder
  • Child with contractures or lower limbs on fixed deformities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mostafa S Ali

Giza, Married, 12668, Egypt

Location

Related Publications (1)

  • Ali MS. Whole Body Vibration or Virtual Reality on Muscle Strength and Activity of Daily Living in Children With Burn: A Comparative Trial. Physiother Res Int. 2025 Oct;30(4):e70102. doi: 10.1002/pri.70102.

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor of pediatric physiotherapy, cairo university

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 25, 2024

Study Start

May 10, 2024

Primary Completion

June 17, 2024

Study Completion

June 17, 2024

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
2 MONTHS

Locations