Clinical trial NCT03720106: The Way to Goal-oriented Therapy Planning in Neurorehabilitation
Official title: The Way to Goal-oriented Therapy Planning in Neurorehabilitation: Adherence to Targeted Clinical Pathways in Subacute Stroke- a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke Rehabilitation
Triage
Keywords: interdisciplinarity
therapy planning
assessment
stroke
neurorehabilitation
physical therapy
occupational therapy
neuropsychology
logopedia
Lead sponsor: Rehaklinik Zihlschlacht AG
Sponsor class: OTHER
Collaborators: name: Luzerner Kantonsspital
First posted: 2018-10-25
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: feasibility study
Primary purpose: OTHER

Brief summary: The aim of this feasibility study is to investigate whether target-oriented treatment planning can be maintained in the rehabilitation of stroke patients using the existing classification (LIMOS) and evidence-based specialist treatment pathways. If the goal-oriented treatment planning cannot be adhered to, reasons for failure should be investigated.

Detailed description: According to Feigin and employees, in 2013 there were 25.7 million people worldwide who survived a stroke. In order to regain independence in everyday life after a mild to severe stroke, a rehabilitation phase is recommended. Rehabilitation is a holistic process with the aim of maximising participation in the daily life of the affected person. Tailor-made interventions with a focus on impairment, activity and participation should be carried out for this purpose. The International Classification of Functioning, Disability and Health (ICF) was developed in a worldwide consensus and declared by the WHO as a generally accepted framework for describing function and health. In rehabilitation, it is considered as standard and is used to speak a uniform language between the disciplines, to understand the needs of patients, to adapt the corresponding interventions to the needs and to measure outcomes. In order to optimally plan the process, Stroke Guidelines recommend to define goals together with the patient and to use standardized and valid assessments. So far, the following assessments have been used for the neurorehabilitation of stroke patients: Barthel Index, Functional Independence Measure and Functional Assessment Measure as well as the Modified Ranking Scale, but according to Ottiger and her colleagues there was a lack of multidisciplinary assessments with good psychometric properties and which are based on ICF. For this reason, the ICF-based multidisciplinary observation scale (LIMOS) was developed in Lucerne. It consists of four multidisciplinary components based on the following ICF domains: motor function, cognition, communication and coping with everyday life. Due to its good psychometric properties, LIMOS was recommended as a multidisciplinary assessment for neurorehabilitation. The Rehabilitation Clinic Zihlschlacht (RZS) has an interprofessional team. Each discipline carries out subject-specific assessments and plans the necessary therapy units based on empirical values. So far, however, there has been no algorithm that records the deficits of a stroke patient on an interdisciplinary basis and uses the results to determine the main therapeutic areas. In RZS, patient satisfaction with the therapy plan in 2017 was 77%. The reasons for dissatisfaction were: Lack of inclusion of needs, lack of adaptation to changing needs, time aspects, lack of information and the proportion of cognitive and motor therapies. Now the therapy planning system is to be optimized. The LIMOS classification should help to record the patient in an interdisciplinary manner and to visualize focal points. Together with the patient, goals are discussed which are weighted on the basis of LIMOS. These results, together with evidence-based subject-specific treatment pathways, are integrated into an algorithm (GOAL) that creates a goal-oriented treatment plan.

The aim of this feasibility study is to investigate whether target-oriented treatment planning can be maintained in the rehabilitation of stroke patients using the existing classification and evidence-based specialist treatment pathways. If the goal-oriented treatment planning cannot be adhered to, reasons for failure should be investigated.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of ischemic (e.g., anterior, middle or posterior cerebral artery, cerebellar arteries) or haemorrhagic stroke
* subacute stage: 2 weeks to 6 months after the event7
* signed declaration of consent

Exclusion Criteria:

* other cerebrovascular events (sinus vein thrombosis or subarachnoid haemorrhage)
* participation in other intervention studies
* any medical conditions that interfere with the patient's ability to adhere to the target therapy plan as judged by the sponsor-investigator (e.g., severe dementia)

Primary outcomes:
measure: Fidelity
timeFrame: up to 6 months
Secondary outcomes:
measure: Patient satisfaction: questionnaire of the RZS
timeFrame: 72 hours before discharge of the patient
measure: Therapist satisfaction: PSSUQ
timeFrame: 72 hours before discharge of the patient
Other outcomes:
measure: Achievement of longterm goals
timeFrame: 72 hours after admission and 72 hours before discharge of the patient
measure: Achievement of the overall rehabilitation goals
timeFrame: 72 hours after admission and 72 hours before discharge of the patient
Locations:
city: Zihlschlacht
country: Switzerland
facility: Rehaklinik Zihlschlacht, Center for Neurological Rehabilitation
Study officials:
affiliation: Rehaklinik Zihlschlacht
name: Caroline Tanner
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feigin VL, Norrving B, George MG, Foltz JL, Roth GA, Mensah GA. Prevention of stroke: a strategic global imperative. Nat Rev Neurol. 2016 Sep;12(9):501-12. doi: 10.1038/nrneurol.2016.107. Epub 2016 Jul 22.
citation: Cieza A, Ewert T, Ustun TB, Chatterji S, Kostanjsek N, Stucki G. Development of ICF Core Sets for patients with chronic conditions. J Rehabil Med. 2004 Jul;(44 Suppl):9-11. doi: 10.1080/16501960410015353.
citation: Weimar C, Kurth T, Kraywinkel K, Wagner M, Busse O, Haberl RL, Diener HC; German Stroke Data Bank Collaborators. Assessment of functioning and disability after ischemic stroke. Stroke. 2002 Aug;33(8):2053-9. doi: 10.1161/01.str.0000022808.21776.bf.
citation: Ottiger B, Vanbellingen T, Gabriel C, Huberle E, Koenig-Bruhin M, Pflugshaupt T, Bohlhalter S, Nyffeler T. Validation of the new Lucerne ICF based Multidisciplinary Observation Scale (LIMOS) for stroke patients. PLoS One. 2015 Jun 25;10(6):e0130925. doi: 10.1371/journal.pone.0130925. eCollection 2015.