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Citation
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Neubauer H, Stolle A, Ripper S, Klimitz F, Ziegenthaler H, Strupat M, Kneser U, Harhaus L. Trials 2019; 20(1): e752. |
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Affiliation
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Department of Hand, Plastic and Reconstructive Surgery, Burn Center, BG Trauma Center Ludwigshafen, Plastic- and Hand Surgery, University of Heidelberg, Ludwig-Guttmann-Str. 13, 67071, Ludwigshafen, Germany. leila.harhaus@bgu-ludwigshafen.de. |
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Abstract
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BACKGROUND: Severe burn injuries result in relevant restrictions of physical capacity as well as psychological and social integrity and require a specialized rehabilitation. There is a common agreement, among national as well as international burn associations, that burn rehabilitation is a complex, dynamic process which needs an interdisciplinary and specialized treatment team. There is wide agreement that more research is needed in this field.
METHODS/DESIGN: The aim of the study is to examine the effectiveness and efficiency of our new ICF (International Classification of Functioning, Disability and Health)-based rehabilitation for thermal injuries. Because of ethical reasons, we have chosen a prospective non-randomized design, which takes place at two different rehabilitation centers. At center A, a newly developed ICF-based rehabilitation program was established; at rehabilitation center B, a well-established rehabilitation program has existed for 20 years and is used as reference. The primary research question addresses the "Pre-post comparison of the physical and psychological outcome measurements," secondary question I looks at the "Examination of the non-inferiority of the new treatment concept with the established concept," and secondary question II is the "Analysis of the rehabilitation process based on the rehabilitation cycle." Only patients of the two burn rehabilitation centers who are insured by workers' compensation will be asked to participate in this study to avoid outcome bias by insurance status. A physical examination (physical working capacity testing, grip strength, range of motion, and scar evaluation by Cutometer and Vancouver Scar Scale) and a standardized questionnaire battery (Burn Specific Health Scale-Brief , Short Form 36, Impact of Event Scale-Revised, the German version of the Symptom Checklist, the Freiburg Social Support Questionnaire, Patient/Client Satisfaction Questionnaire, Disabilities of the Arm, Shoulder and Hand, and Lower Extremity Functional Scale ) measure physical and psychological conditions. Data will be taken on admission, during stay, and on discharge of the rehabilitation program and at follow-up 3 and 12 months after discharge. A minimum of 162 participants will be enrolled in this clinical longitudinal, prospective, observational study.
DISCUSSION: The proof of the effectiveness of the ICF-based rehabilitation program for thermal injuries will give evidence in a comprehensive way for the first time in this field. As result, a standardized rehabilitation concept will be introduced, which can be provided to other rehabilitation institutions treating thermal injuries. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00017702. Registered on 2 September 2019.
Language: en |