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The Way to Goal-oriented Therapy Planning in Neurorehabilitation

Primary Purpose

Stroke Rehabilitation, Triage

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
GOAL therapy plan
Sponsored by
Rehaklinik Zihlschlacht AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke Rehabilitation focused on measuring interdisciplinarity, therapy planning, assessment, stroke, neurorehabilitation, physical therapy, occupational therapy, neuropsychology, logopedia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Rehaklinik Zihlschlacht, Center for Neurological RehabilitationRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

treatment arm

Arm Description

In this arm the GOAL therapy plan is used.

Outcomes

Primary Outcome Measures

Fidelity
The deviations of the targeted therapy plan are checked weekly on Sunday by the sponsor-investigator. The deviations are documented in %. If there are some deviations, the reasons for the deviations are checked and analysed descriptively.

Secondary Outcome Measures

Patient satisfaction: questionnaire of the RZS
The patient satisfaction is examined using the questionnaire of the RZS. The results are documented descriptively. the questionnaire contains possible answers to a 5-point likertscale. 1: excellent, 2: very good, 3: good, 4: less good, 5: bad or 1: yes, 2: predominant, 3: partial, 4: rather no, 5: no
Therapist satisfaction: PSSUQ
Using the post-study usability questionnaire (PSSUQ), the therapist satisfaction is evaluated and described descriptively. The rating scale includes a 7-point likert scale with 1: strongly applicable and 7: strongly inapplicable.

Full Information

First Posted
October 4, 2018
Last Updated
October 24, 2018
Sponsor
Rehaklinik Zihlschlacht AG
Collaborators
Luzerner Kantonsspital
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1. Study Identification

Unique Protocol Identification Number
NCT03720106
Brief Title
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

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rehaklinik Zihlschlacht AG
Collaborators
Luzerner Kantonsspital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Rehabilitation, Triage
Keywords
interdisciplinarity, therapy planning, assessment, stroke, neurorehabilitation, physical therapy, occupational therapy, neuropsychology, logopedia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
feasibility study
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment arm
Arm Type
Other
Arm Description
In this arm the GOAL therapy plan is used.
Intervention Type
Other
Intervention Name(s)
GOAL therapy plan
Intervention Description
The GOAL algorithm designs a therapy plan based on the LIMOS assessment, patient goals and subject-specific treatment pathways. The adherence of this therapy plan is examined.
Primary Outcome Measure Information:
Title
Fidelity
Description
The deviations of the targeted therapy plan are checked weekly on Sunday by the sponsor-investigator. The deviations are documented in %. If there are some deviations, the reasons for the deviations are checked and analysed descriptively.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Patient satisfaction: questionnaire of the RZS
Description
The patient satisfaction is examined using the questionnaire of the RZS. The results are documented descriptively. the questionnaire contains possible answers to a 5-point likertscale. 1: excellent, 2: very good, 3: good, 4: less good, 5: bad or 1: yes, 2: predominant, 3: partial, 4: rather no, 5: no
Time Frame
72 hours before discharge of the patient
Title
Therapist satisfaction: PSSUQ
Description
Using the post-study usability questionnaire (PSSUQ), the therapist satisfaction is evaluated and described descriptively. The rating scale includes a 7-point likert scale with 1: strongly applicable and 7: strongly inapplicable.
Time Frame
72 hours before discharge of the patient
Other Pre-specified Outcome Measures:
Title
Achievement of longterm goals
Description
The long-term goals are defined 72 hours after admission and are evaluated 72 hours before discharge of the patient. . The results are dichotomous (1: achieved and 2: not achieved). An overall score in percent is calculated.
Time Frame
72 hours after admission and 72 hours before discharge of the patient
Title
Achievement of the overall rehabilitation goals
Description
The rehabilitation goals are defined within the first week 72 hours after admission in the first rehabilitation meeting and evaluated 72h before discharge according to the national measurement plan of the ANQ. The scale is dichotomous (1: achieved and 2: not achieved). An overall score is calculated in %. The results of the primary outcome "Fidelity" are used to examine possible correlations with the results of the goal achievement (long-term goals and rehab goals). The value 1 stands for a strong correlation, while the value 0 stands for no correlation.
Time Frame
72 hours after admission and 72 hours before discharge of the patient

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Tanner
Phone
0041 071 424 37 59
Email
c.tanner@rehaklinik-zihlschlacht.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Carsten Möller
Phone
0041 071 424 30 22
Email
c.möller@rehaklinik-zihlschlacht.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Tanner
Organizational Affiliation
Rehaklinik Zihlschlacht
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehaklinik Zihlschlacht, Center for Neurological Rehabilitation
City
Zihlschlacht
ZIP/Postal Code
8588
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Tanner
Phone
+41-71-424 3759
Email
c.tanner@rehaklinik-zihschlacht.ch
First Name & Middle Initial & Last Name & Degree
Carsten Möller, MD
Email
c.möller@rehaklinik-zihlschlacht.ch
First Name & Middle Initial & Last Name & Degree
Oliver Stoller
First Name & Middle Initial & Last Name & Degree
Raoul Schweinfurther
First Name & Middle Initial & Last Name & Degree
Evelin Lüchinger
First Name & Middle Initial & Last Name & Degree
Nathalie Hollenstein
First Name & Middle Initial & Last Name & Degree
Bettina Lüchinger
First Name & Middle Initial & Last Name & Degree
Anja Locher
First Name & Middle Initial & Last Name & Degree
Anna Coppers
First Name & Middle Initial & Last Name & Degree
Sebastian Jehle
First Name & Middle Initial & Last Name & Degree
Svenja Glönkler
First Name & Middle Initial & Last Name & Degree
Bettina Arca
First Name & Middle Initial & Last Name & Degree
Stephanie Rabiega
First Name & Middle Initial & Last Name & Degree
Manuela Möller
First Name & Middle Initial & Last Name & Degree
Simon Hirsiger
First Name & Middle Initial & Last Name & Degree
Peggy Tiebel

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27448185
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.
Results Reference
background
PubMed Identifier
15370742
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.
Results Reference
background
PubMed Identifier
12154262
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.
Results Reference
background
PubMed Identifier
26110769
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. Erratum In: PLoS One. 2015;10(7):e0134186. Plugshaupt, Tobias [corrected to Pflugshaupt, Tobias].
Results Reference
background

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The Way to Goal-oriented Therapy Planning in Neurorehabilitation

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