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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02950675
Other study ID # 104-9848B
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2016
Est. completion date July 2019

Study information

Verified date January 2019
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The relationship of body function, participation and quality of life in patients with burn: A longitudinal study


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.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date July 2019
Est. primary completion date July 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 74 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in bodily function in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up Vancouver Scar Scale (VSS) baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Secondary Change in muscle strength change in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up MicroFET baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Secondary Change in activities of daily living in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up Functional Independence Measure (FIM) baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Secondary Change in individual independency in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up Manual for the Care and Needs Scale baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
Secondary Change in quality of life in baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month follow up The Burn-Specific Health Scale-Brief baseline, 3 month, 12 month, 18 month, 24 month, 30 month and 36 month
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