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Completed

NCT Number: NCT02950675

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

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

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Key information

Age range

14 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

  2. 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)

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 1, 2016
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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