INTERACTION, Monitoring of Stroke Patients in Hospital an... | NCT02118363

Studies
INTERACTION, Monitoring of Stroke Patients in Hospital and Home Environment

NCT02118363

Sponsor

University of Zurich

Status

Completed

Last Update Posted

May 8, 2018Actual

Enrollment

8Actual

Phase

Not provided

Conditions

Stroke

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
seventh framework programme	Other Grant/Funding Number	287351

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Dec 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

Apr 8, 2014

First Submission Date that Met QC Criteria

Apr 15, 2014

First Posted Date

Apr 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 7, 2018

Last Update Posted Date

May 8, 2018Actual

Name	Class
University of Twente	OTHER
University of Pisa	OTHER
Roessingh	UNKNOWN
XSens technologies B.V.

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Clinical assessment and monitoring of balance and arm function in stroke patients with sensor based measurement, in clinical and home environment.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Measure	Description	Time Frame
proof of concept		3 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age: 18 or above
Previous Stroke in the personal history
Able to walk 10 meters. A walking aid (unilateral or bilateral) is permitted
Able to walk without special shoes
Able to raise the arm against gravity
Able to read and understand questionnaires and able to execute commands
Able and willing to participate in the study
Singed Informed Consent

Exclusion Criteria:

Contraindications on ethical grounds (vulnerable persons)
known or suspected non-compliance, drug or alcohol abuse,
Severe aphasia
Severe dementia
Severe depression
Relevant medical disease or increased risk of rehospitalization
Severe sensory deficits
Severe neglect

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

subakut or chronic stroke patients

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Cereneo		Vitznau		6354	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29707537	Derived	Held JPO, Klaassen B, Eenhoorn A, van Beijnum BF, Buurke JH, Veltink PH, Luft AR. Inertial Sensor Measurements of Upper-Limb Kinematics in Stroke Patients in Clinic and Home Environment. Front Bioeng Biotechnol. 2018 Apr 12;6:27. doi: 10.3389/fbioe.2018.00027. eCollection 2018.

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases