StrokeINTERACTIONNCT02118363
INTERACTION, Monitoring of Stroke Patients in Hospital and Home Environment
An observational study of Stroke, run by University of Zurich at 1 site in Switzerland.
Trial summary
Clinical assessment and monitoring of balance and arm function in stroke patients with sensor based measurement, in clinical and home environment. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2014to Dec 2017
- Phase
- Observational
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: subakut or chronic stroke patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proof of Concept Study of the INTERACTION Technology, Monitoring of Stroke Patients in Hospital and Home Environment
Clinical assessment and monitoring of balance and arm function in stroke patients with sensor based measurement, in clinical and home environment.
- Conditions
- Stroke
- Keywords
- upper limb, lower limb, monitoring, assessment, sensor
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
proof of concept
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente, University of Pisa, Roessingh, XSens technologies B.V., Smartex S.r.l.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118363
- Sponsor's protocol ID
- 13101
- Other IDs
- seventh framework programme
- Acronym
- INTERACTION
- Status last verified
- May 2018
- First submitted
- 8 Apr 2014
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29707537
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Study of the INTERACTION Technology, Monitoring of Stroke Patients in Hospital and Home Environment
- ClinicalTrials.gov ID
- NCT02118363
- Acronym / sponsor ID
- INTERACTION / 13101
- Conditions
- Stroke
- Keywords
- upper limb, lower limb, monitoring, assessment, sensor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University of Twente, University of Pisa, Roessingh, XSens technologies B.V., Smartex S.r.l.
- Study start
- Apr 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 21 Apr 2014 (estimated)
- 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.
Clinical assessment and monitoring of balance and arm function in stroke patients with sensor based measurement, in clinical and home environment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- subakut or chronic stroke patients
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- Contraindications on ethical grounds (vulnerable persons)
- known or suspected non-compliance, drug or alcohol abuse,
- Severe aphasia
- Severe dementia
- Severe depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
proof of concept
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Derived from this study: PubMed 29707537Held 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.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by University of Zurich 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 8 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proof of concept (time frame: 3 month). 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 NCT02118363, which also lists 1 linked publication.
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 8 May 2018.