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Dr. med. Anne Barzel

Zentrum für Psychosoziale Medizin

Institut für Allgemeinmedizin

Universitätsklinikum Hamburg-Eppendorf

Martinistraße 52,

20246 Hamburg

Direktor: Prof. Dr. med. Martin Scherer

Phone: +49 40 7419-52400;

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Fostering the participation of stroke patients in SHI-accredited physician care through Constraint Induced Movement Therapy (HOMECIMT)

Anne Barzel1, Gesche Ketels2, Britta Tetzlaff1, Heike Krüger2, Anne Daubmann3, Karl Wegscheider3, Martin Scherer1

1Institut für Allgemeinmedizin, 2Physiotherapie, 3Institut für Medizinische Biometrie und Epidemiologie, Universitätsklinikum Hamburg-Eppendorf

 

Participation should be central to rehabilitation (SGB IX). Activating therapy forms such as Constraint Induced Movement Therapy (CIMT) help patients, by means of repetitive exercises with everyday relevance, to implement learned skills successfully in their everyday life and thus in their participation. In the SHI-accredited physician-based care of chronic stroke patients, a therapy concept that is explicitly oriented to the criterion of participation is so far lacking.

 

The aim of this study is to examine the effectiveness of a modified form of Constraint Induced Movement therapy for the home setting ("CIMT at home") for chronic stoke patients in SHI care in comparison to conventional physiotherapy and occupational therapy ("therapy as usual") with regard to the ability to participate in everyday activities.

 

A cluster-randomised controlled study (RCT) with the physiotherapy and occupational therapy practices as clusters. 60 therapy practices which treat patients after a stroke will be cluster-randomised following a baseline patient survey (n=189, average of three per practice) into an intervention group and a control group. The patients receive, according to which study arm their therapist is assigned to, either "CIMT at home" (intervention) or "therapy as usual" (control group) for four weeks. The case number planning is based on a cluster size of three participants per practice and an intra-cluster correlation of 0.05 (effect size 0.5; alpha error likelihood 0.05; power 0.80). The data collection is conducted by blinded assessors in the framework of visits to the patients' homes in a pre/post/follow-up design.

 

Two primary endpoints will be evaluated in a hierarchical manner (final test principle). First of all, the activity and participation of the more greatly affected hand/arm will be measured through the Motor Activity Log (Quality of Movement, MAL-QOM) and then the motor function will be measured in the Wolf Motor Function Test (Performance Time, WMFT-PT). Secondary dependent variables are the frequency of use of the arm (Motor Activity Log – Amount of Use), functionality of hand and arm (Wolf Motor Function Test – Functional Ability), finger dexterity (Nine-Hole-Peg-Test), stroke-related quality of life (Stroke Impact Scale), independence (Barthel Index) and everyday competence (Instrumental Activities of Daily Living).

 

The database for the analysis is the ITT (Intention to Treat) population of the clinical primary data of the participants (MAL-QOM) and/or the simply blinded assessors (WMFT-PT) and the characteristics of the clusters (practices). Statistical analysis: mixed models of the differences between intervention and control group with the mean differences as fixed effects and the practice effects as random effects controlling for baseline and gender of the participants and therapists.

 

If "CIMT at home" proves to be effective, a target-group-specific treatment offer in SHI care in terms of ability to participate in everyday activities will be available.




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