Trial document




drksid header

  DRKS00005224

Trial Description

start of 1:1-Block title

Title

Goal orientation for outpatients as motivational basis to improve the treatment success in physiotherapy. A controlled clinical trial

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Goal orientation is regarded as a motivating factor, that enables influencing the degree of motivation. The aim of this study is to determine whether therapy motivation and consequently the treatment outcome can be improved by a jointly planned goal orientation between patients and their therapeutic caregivers. Therefore two groups of outpatients with disorders of the musculoskeletal system will be treated with physiotherapy and compared. One group receives the usual treatment. The patients of the second group receive additionally a controlled target planning and are checked for improvements regularly.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Background: Goal orientation of patients is considered as an important factor to support motivation for therapy in outpatient physiotherapy. However, evidence regarding the efficacy of this factor shows an uncertain data situation. Moreover, so far it is not obvious how it can be implemented in the daily physiotherapy practice.
Goal: Aim of the controlled trial is to determine whether a common goal setting and agreement between patients and their responsible therapists inclusive regular monitoring, improves the motivation for therapy, and consequently, the treatment outcome.
Method: In a clinical controlled trial two groups of patients with musculoskeletal disorders on the lower limb are compared. While the control group gets the usual standard treatment, the intervention group receives an additional goal-orientation. This will be controlled by the therapist and formulated by the SMART principle. Outcome parameters are the Stair Climb Power Test, pain relief and improvement in joint mobility. In addition the scores in the goal attainment scale, patient satisfaction and the portion of failed treatment appointments are compared

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005224
  •   2014/01/03
  •   [---]*
  •   yes
  •   Approved
  •   2013-97, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   musculoskeletal disorder
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   standard physiotherapy without goal planning initiated by the responsible physiotherapist
  •   Additional to treatment the patients receive a goal planning, which is initiated by the responsible physiotherapist and is monitored by control measurements regularly
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Improvement of performance capability at the Stair Climb Power Test. First measurement is at the first appointment for treatment, second measurement is the last appointment for treatment.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Improvement of joint mobility based on the comparison of entry and exit value using the goniometer,
Pain relief based on the comparison of entry and exit value using the Visual Analogue Scale (VAS),
Level of target achievement based on Goal Attainment Scale (GAS) subsequent to the last treatment appointment,
Proportion of perceived treatment appointments,
Patient satisfaction using the modified Munich questionnaire on patient contentment (MFBP-18)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/01/01
  •   128
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

The study population consists of adult men and women. Patients will be recruited, who receive a medical prescription for an outpatient physical therapy due to a musculoskeletal problem of the lower extremity. Another inclusion criterion is the type of functional problem. It should be either a restricted joint mobility and/or pain related.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Self-paying patients are not included, since a high motivation can be assumed in this patient group, which would falsify the results

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Gesundheits- und Pflegewissenschaft der Martin-Luther-Universität Halle-Wittenberg; Medizinische Fakultät
    • Magdeburger Str.8
    • 06112  Halle (Saale)
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Medizinische Fakultät, Institut für Gesundheits- und Pflegewissenschaft der Martin-Luther-Universität Halle-Wittenberg
    • Ms.  Prof. Dr.  Margarete  Landenberger 
    • Magdeburger Str. 8
    • 06112  Halle (Saale)
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Formatio, private Berufsfachschule für Physiotherapie
    • Mr.  MSc  Jürgen  Baier 
    • Porschestr. 5b
    • 84030  Landshut
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Mr.  M.Sc.  Jürgen  Baier 
    • Rebhuhnweg 1
    • 84036  Landshut
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2015/06/10
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.