Stroke RehabilitationNCT03720106
The Way to Goal-oriented Therapy Planning in Neurorehabilitation
A study testing GOAL therapy plan in people with Stroke Rehabilitation and Triage, run by Rehaklinik Zihlschlacht AG at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke Rehabilitation, Triage
- What is being tested?
- GOAL therapy plan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Rehaklinik Zihlschlacht, Center for Neurological Rehabilitation
Zihlschlacht, 8588
Caroline Tanner, +41-71-424 3759, c.tanner@rehaklinik-zihschlacht.ch
Carsten Möller, MD, c.möller@rehaklinik-zihlschlacht.ch
About this study
Official title: The Way to Goal-oriented Therapy Planning in Neurorehabilitation: Adherence to Targeted Clinical Pathways in Subacute Stroke- a Feasibility Study
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.
Read the 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.
- Conditions
- Stroke Rehabilitation, Triage
- Being tested
- GOAL therapy plan
- Keywords
- interdisciplinarity, therapy planning, assessment, stroke, neurorehabilitation, physical therapy, occupational therapy, neuropsychology, logopedia
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GOAL therapy planOther
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.
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Other | In this arm the GOAL therapy plan is used. Receives: Other: GOAL therapy plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Secondary outcomes (2)
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
Measured: 72 hours before discharge of the patient
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.
Measured: 72 hours before discharge of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start1 Jul 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stroke RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- feasibility study
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rehaklinik Zihlschlacht AG
- Sponsor type
- University, hospital or other
- Collaborators
- Luzerner Kantonsspital
- Responsible party
- Sponsor
- Investigators
- Caroline Tanner, Principal investigator, Rehaklinik Zihlschlacht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720106
- Sponsor's protocol ID
- RZS_01_2018
- Status last verified
- Sep 2018
- First submitted
- 4 Oct 2018
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27448185Cieza 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.
PubMed 15370742Weimar 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.
PubMed 12154262Ottiger 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.
PubMed 26110769
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Way to Goal-oriented Therapy Planning in Neurorehabilitation: Adherence to Targeted Clinical Pathways in Subacute Stroke- a Feasibility Study
- ClinicalTrials.gov ID
- NCT03720106
- Acronym / sponsor ID
- RZS_01_2018
- Conditions
- Stroke Rehabilitation, Triage
- Keywords
- interdisciplinarity, therapy planning, assessment, stroke, neurorehabilitation, physical therapy, occupational therapy, neuropsychology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Rehaklinik Zihlschlacht AGUniversity, hospital or other
- Collaborators
- Luzerner Kantonsspital
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- feasibility study
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Other | Other: GOAL therapy planIn this arm the GOAL therapy plan is used. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GOAL therapy planThe 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. | Other | treatment arm |
Primary outcome
Fidelity
Time frame: up to 6 months
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.
2 secondary outcomes
Patient satisfaction: questionnaire of the RZS
Time frame: 72 hours before discharge of the patient
Therapist satisfaction: PSSUQ
Time frame: 72 hours before discharge of the patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Background: PubMed 27448185Feigin 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.
- Background: PubMed 15370742Cieza 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.
- Background: PubMed 12154262Weimar 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.
- Background: PubMed 26110769Ottiger 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline Tanner principal investigator
Rehaklinik Zihlschlacht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GOAL therapy plan in people with Stroke Rehabilitation and Triage, run by Rehaklinik Zihlschlacht AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Tanner (0041 071 424 37 59, c.tanner@rehaklinik-zihlschlacht.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fidelity (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03720106, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.