Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients

NCT ID: NCT04119479

Last Updated: 2021-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

227 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-27

Study Completion Date

2020-10-31

Brief Summary

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Observational study of functional recovery of stroke patients after discharge from rehabilitation

Detailed Description

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Cerebrovascular diseases, such as stroke, are among the greatest challenges in healthcare. This proves the importance of neuro-rehabilitative research. Stroke research is often focused on the acute treatment phase as well as the inpatient rehabilitation. A remaining question is how do stroke patients clinically develop after being discharged from the hospital? How stable are the achieved rehabilitation effects and how much more clinical improvement is seen in the following time period, especially with regard to ICF functionality? In this observational longitudinal study, the current practice of neurorehabilitation will be investigated and the influence of motor skills, cognition, care situation, depression, information and fatigue on functional recovery as well as participation, autonomy and quality of life will be evaluated. Stroke patients will be examined at the end of rehabilitation, after three, six and 12 months. In addition, a group of chronic patients undergoes the same examinations and thereby represents a comparison group.

Conditions

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Stroke

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Ischemic or haemorrhagic stroke according to ICD 10 I61-I69
* Patients in or after completion of rehabilitation phases C and D according to BAR criteria
* Age \>= 18
* Sufficient knowledge of German
* Existing declaration of consent
* Deficit still existing (Rankin score of at least 1 at inclusion)

Exclusion Criteria

* need for care prior stroke
* SAB, craniocerebral trauma, TIA as primary diagnosis
* Severe pre-existing psychiatric disease
* Participation in follow-up examination not possible
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsche Rentenversicherung

OTHER

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Götz Thomalla, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, University Medical Center Hamburg-Eppendorf

Christian Gerloff, Prof. Dr.

Role: STUDY_CHAIR

Department of Neurology, University Medical Center Hamburg-Eppendorf

Locations

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Klinikum Bad Bramstedt - Klinik für Neurologische Rehabilitation

Bad Bramstedt, , Germany

Site Status

Rehaklinik Damp - Neurologie

Damp, , Germany

Site Status

Rehaklinik Geesthacht - Neurologie

Geesthacht, , Germany

Site Status

RehaCentrum Hamburg - Neurologische Rehabilitation

Hamburg, , Germany

Site Status

Universitätsklinikum Hamburg-Eppendorf, Neurologie

Hamburg, , Germany

Site Status

MediClin Klinikum Soltau - Neurologische Rehabilitation

Soltau, , Germany

Site Status

Countries

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Germany

References

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Birke G, Wolf S, Ingwersen T, Bartling C, Bender G, Meyer A, Nolte A, Ottes K, Pade O, Peller M, Steinmetz J, Gerloff C, Thomalla G. Protocol for a multicenter observational prospective study of functional recovery from stroke beyond inpatient rehabilitation - The Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients (IMPROVE). Neurol Res Pract. 2020 Apr 6;2:10. doi: 10.1186/s42466-020-00056-2. eCollection 2020.

Reference Type BACKGROUND
PMID: 33324916 (View on PubMed)

Wolf S, Holm SE, Ingwersen T, Bartling C, Bender G, Birke G, Meyer A, Nolte A, Ottes K, Pade O, Peller M, Steinmetz J, Gerloff C, Thomalla G. Pre-stroke socioeconomic status predicts upper limb motor recovery after inpatient neurorehabilitation. Ann Med. 2022 Dec;54(1):1265-1276. doi: 10.1080/07853890.2022.2059557.

Reference Type DERIVED
PMID: 35510813 (View on PubMed)

Ingwersen T, Wolf S, Birke G, Schlemm E, Bartling C, Bender G, Meyer A, Nolte A, Ottes K, Pade O, Peller M, Steinmetz J, Gerloff C, Thomalla G. Long-term recovery of upper limb motor function and self-reported health: results from a multicenter observational study 1 year after discharge from rehabilitation. Neurol Res Pract. 2021 Dec 27;3(1):66. doi: 10.1186/s42466-021-00164-7.

Reference Type DERIVED
PMID: 34955097 (View on PubMed)

Other Identifiers

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IMPROVE

Identifier Type: -

Identifier Source: org_study_id

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