NCT03720106

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

October 25, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

October 4, 2018

Last Update Submit

October 24, 2018

Conditions

Stroke RehabilitationTriage

Keywords

interdisciplinaritytherapy planningassessmentstrokeneurorehabilitationphysical therapyoccupational therapyneuropsychologylogopedia

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 6 months

Secondary Outcomes (2)

  • Patient satisfaction: questionnaire of the RZS

    72 hours before discharge of the patient

  • Therapist satisfaction: PSSUQ

    72 hours before discharge of the patient

Other Outcomes (2)

  • Achievement of longterm goals

    72 hours after admission and 72 hours before discharge of the patient

  • Achievement of the overall rehabilitation goals

    72 hours after admission and 72 hours before discharge of the patient

Study Arms (1)

treatment arm

OTHER

In this arm the GOAL therapy plan is used.

Other: GOAL therapy plan

Interventions

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.

treatment arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehaklinik Zihlschlacht, Center for Neurological Rehabilitation

Zihlschlacht, 8588, Switzerland

RECRUITING

Related Publications (4)

  • 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.

    PMID: 27448185BACKGROUND

  • 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.

    PMID: 15370742BACKGROUND

  • 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.

    PMID: 12154262BACKGROUND

  • 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.

    PMID: 26110769BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Caroline Tanner

    Rehaklinik Zihlschlacht

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Tanner

CONTACT

0041 071 424 37 59c.tanner@rehaklinik-zihlschlacht.ch

Carsten Möller

CONTACT

0041 071 424 30 22c.möller@rehaklinik-zihlschlacht.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: feasibility study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2018

First Posted

October 25, 2018

Study Start

July 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

October 25, 2018

Record last verified: 2018-09

Locations

CH(1)