Trial document





This trial has been registered retrospectively.
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  DRKS00017702

Trial Description

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Title

Evaluation of an ICF-based Rehabilitation Concept for Thermal Injuries

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The aim of the study is to investigate the effectiveness of a function-oriented rehabilitation concept after severe burns.

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Brief Summary in Scientific Language

The aim of the study is to examine effectiveness and efficiency of our new ICF (International Classification of Functioning, Disability and Health)-based rehabilitation concept.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00017702
  •   2019/09/02
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  •   yes
  •   Approved
  •   837.236.16, Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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Health Condition or Problem studied

  •   T20-T25 -  Burns and corrosions of external body surface, specified by site
  •   T95 -  Sequelae of burns, corrosions and frostbite
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Interventions/Observational Groups

  •   No intervention besides the standard rehabilitation program in both centers is planned.

    Both rehabilitation programs have a multidisciplinary team approach. Main elements are physical therapy, occupational therapy, sports therapy and psychotherapy. Rehabilitative nursing for skin and wound care is carried out if necessary. Additional support by social workers and consultations of multiple other medical disciplines such as pain medicine are offered if needed. Meetings of a multidisciplinary team focusing on the quality of patients’ lives are held weekly. The rehabilitation program in center A contains more occupational therapy; at center B the program contains additional balneotherapy. Center A is located at the campus of a level 1 trauma center, whereas center B is located in a health resort. The duration of the rehabilitation is planned in both facilities with 3 weeks and can be extended individually.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Physical outcome measurements:
Physical working capacity test 150 (PWC 150)
Grip strength
Muscle function test by Jamar
Range of motion (ROM) of large joints

Burn scar assessment:
Vancouver scar scale
Cutometery Cutometer® MPA 580 (Courage + Khazaka)

Self-reporting questionnaires:
The Disabilities of the Arm, Shoulder and Hand (DASH)
Lower Extremity Functional Scale questionnaire for Patients with foot and / or leg injuries (LEFS):


Psychological outcome measurements:
Burn-specific health scale brief questionnaire (BSHS-B; German Version)
Short Form Health Survey (SF-36, German Version)
Symptom-Checklist-9 (SCL-9-K)
Impact of Event Scale-Revised (IES-R)


Rehabilitation goals: linked to the ICF categories.

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2018/11/07
  •   162
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

the participants are admitted to the two burn rehabilitation centers in Germany dependent on proximity to their place of residence and availability of a contemporary treatment capacity.

Indications for burn rehabilitation
Main indications
- Burns degree II° ≥ 20% TBSA
- Burns degree III° ≥ 10% TBSA
- Burns of face, hands, feet or genital area
- Scarring with significant limitations of the large joints

Further indications
- remaining functional neurological deficit
- functional deficits after high-voltage accident
- Limb loss
- lasting loss of condition and strength
- problematic psychosocial situation
- psychiatric disorders after trauma (adjustment disorders, post-traumatic stress reactions, phobic reactions)

Inclusion criteria:
- written consent
- Sufficient knowledge of German in speech and writing
- Age ≥18 years
- Work-related accident

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Exclusion Criteria

- Serious cognitive impairment (eg. advanced dementia, acute psychosis, traumatic brain injury)
- Declining of the study

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Addresses

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    • BG - Unfallklinik LudwigshafenKlinik für Hand-, Plastische und Rekonstruktive Chirurgie- Schwerbrandverletztenzentrum -Klinik für Plastische Chirurgie der Ruprecht-Karls-Universität Heidelberg
    • Ms.  Prof. Dr.   Leila  Harhaus 
    • Ludwig-Guttmann-Str. 13
    • 67071  Ludwigshafen
    • Germany
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    • BG - Unfallklinik LudwigshafenKlinik für Hand-, Plastische und Rekonstruktive Chirurgie- Schwerbrandverletztenzentrum -Klinik für Plastische Chirurgie der Ruprecht-Karls-Universität Heidelberg
    • Ms.  Prof. Dr. med.  Leila  Harhaus 
    • Ludwig-Guttmann-Str. 13
    • 67071  Ludwigshafen
    • Germany
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    • BG UnfallklinikKlinik für Hand-, Plastische und Rekonstruktion Chirurgie-Schwerbrandverletztenzentrum
    • Mr.  Dr.  Hubert  Neubauer 
    • Ludwig-Guttmann-Str. 13
    • 67071  Ludwigshafen
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Gesetzliche Unfallversicherung e. V.
    • Glinkastr. 40
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Neubauer, H., Stolle, A., Ripper, S. et al. Evaluation of an International Classification of Functioning, Disability and Health-based rehabilitation for thermal burn injuries: a prospective non-randomized design. Trials 20, 752 (2019). https://doi.org/10.1186/s13063-019-3910-6
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