The Relationship of Body Function, Participation and Quality of Life in Patients With Burn: A Longitudinal Study

January 31, 2021 updated by: Chang Gung Memorial Hospital
The relationship of body function, participation and quality of life in patients with burn: A longitudinal study

Study Overview

Status

Completed

Conditions

Detailed Description

Early rehabilitation to partial-thickness and full-thickness dermal injury are of vital importance for burn patient. Literature reviews have shown that burn patients experiences ADL and quality of life (QOL) difficulties. Due to varied severity, the outcome and expression of each patient also differs. The limitation of body function may consequently affect social participation and QOL thereafter.

Study Type

Observational

Enrollment (Actual)

79

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 74 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The investigators will have Normal Adult (n=30~40) and Burn Patient (n=80-90) from 14-74 years old under consent of their family.

Description

Inclusion Criteria:

  • Clinical diagnosis of burn injuries admitted to Burn Center or followed in burn clinic
  • Age >14
  • No mental diseases
  • Understand written Chinese or could complete the questionnaires with staff's assistance

Exclusion Criteria:

  • Died during or after hospitalization
  • Refused to participate in the investigation
  • Concurrent medical illness that affecting the subjectivity of post burn sequelae (ex. progressive muscular or mental diseases, trauma or seizure)
  • Age >74

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Normal Adult
Control:Normal Adult
Burn Patient
The burn patient will be identified according to the diagnoses (ICD-9-CM code: 940-949).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bodily function in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
Time Frame: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Vancouver Scar Scale (VSS)
baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle strength change in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
Time Frame: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
MicroFET
baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Change in activities of daily living in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
Time Frame: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Functional Independence Measure (FIM)
baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Change in individual independency in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
Time Frame: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Manual for the Care and Needs Scale
baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Change in quality of life in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up
Time Frame: baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
The Burn-Specific Health Scale-Brief
baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (ACTUAL)

July 1, 2019

Study Completion (ACTUAL)

July 1, 2019

Study Registration Dates

First Submitted

October 10, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (ESTIMATE)

November 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 31, 2021

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104-9848B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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