Interdisciplinary Platform for Rehabilitation Research and Innovative Care of Stroke Patients

NCT04119479 | Completed

• 1 other identifier: IMPROVE
• Study Type: observational
• Target: 227
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

Stroke

Keywords

Functional recovery; Neurorehabilitation; Stroke

Outcome Measures

Primary Outcomes (1)

• Compound score

  Compound outcome-parameter for functional recovery (from upper limb motor scores, e.g. Fugl-Meyer assessment, grip force, nine-hole peg test).

  12 months after discharge from rehabilitation

Secondary Outcomes (18)

• Aphasia test

  3, 6 and 12 months after discharge from rehabilitation

• Apraxia screen of TULIA (AST)

  3, 6 and 12 months after discharge from rehabilitation

• Autonomy and participation

  3, 6 and 12 months after discharge from rehabilitation

• Fatigue scale for motor function and cognition (FSMC)

  3, 6 and 12 months after discharge from rehabilitation

• Fugl-Meyer assessment upper extremity (FMA)

  3, 6 and 12 months after discharge from rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with the diagnoses cerebral infarction and/or cerebral hemorrhage corresponding to the diagnoses of ICD 10 I61-I69 from rehabilitation phases C and D according to the criteria of the Bundesarbeitsgemeinschaft für Rehabilitation (BAR) shall be included at the end of inpatient rehabilitation therapy. The spectrum of patients recruited should focus on patients who are still of working age (up to the age of 67).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Deutsche Rentenversicherung: collaborator

Study Sites (6)

Klinikum Bad Bramstedt - Klinik für Neurologische Rehabilitation

Bad Bramstedt, 24576, Germany

Location

Rehaklinik Damp - Neurologie

Damp, 24351, Germany

Location

Rehaklinik Geesthacht - Neurologie

Geesthacht, 21502, Germany

Location

RehaCentrum Hamburg - Neurologische Rehabilitation

Hamburg, 20097, Germany

Location

Universitätsklinikum Hamburg-Eppendorf, Neurologie

Hamburg, 20246, Germany

Location

MediClin Klinikum Soltau - Neurologische Rehabilitation

Soltau, 29614, Germany

Location

Related Publications (3)

• 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.

  PMID: 33324916 BACKGROUND

• 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.

  PMID: 35510813 DERIVED

• 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.

  PMID: 34955097 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Götz Thomalla, Prof. Dr.

  Department of Neurology, University Medical Center Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

• Christian Gerloff, Prof. Dr.

  Department of Neurology, University Medical Center Hamburg-Eppendorf

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: October 8, 2019
• Study Start: June 27, 2017
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 24 months after main publication.
• Access Criteria: Personal login into UKE data repository.

Locations

DE (6)