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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03135093
Other study ID # 2016-02075
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2017
Est. completion date December 30, 2019

Study information

Verified date January 2020
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This project is a cross-sectional, observational mono-center study with prospective data collecting.

This study aims to further explore quality of upper limb movement in relation to characteristics of visuospatial exploration in stroke subjects and healthy subjects by a applying comprehensive measurements of clinical scales and kinematic data in capacity- and performance-based activities. The results will contribute to assessing and monitoring quality of upper limb movements and visuospatial attention and their relationship.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date December 30, 2019
Est. primary completion date December 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subjects of 18 years and older with chronic ischemic stroke (> 6 month) restricted to one hemisphere (confirmed by CT/MRI)

- With impairments in upper limb function and at least partial ability to lift the arm against gravity, flex and extend the fingers

- Without relevant pre-existing limitations in arm and hand function (orthopaedic, muscular, neurologic)

- Written informed consent after participants's information

Exclusion Criteria:

- Increased muscle tone in the upper limb with limited rang of motion

- Severe sensory deficits in the upper limb

- Clinically significant concomitant disease (affecting the upper limb or impaired vision, e.g. due to glaucoma etc.)

- Contraindications on ethical grounds (vulnerable persons)

- Known or suspected non-compliance, drug or alcohol abuse

- Severe communication or cognitive deficits, that cause inability to follow the procedures

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No Intervention

Locations

Country Name City State
Switzerland cereneo Schweiz AG Vitznau Luzern

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Upper limb movement quality Fugl-Meyer Assessment of the upper extremity (FMA-UE), kinematic data (e.g. joint angles, hand workspace) One day
Primary Visuospatial exploration Eye-tracking data (e.g. area of interest, eye movements: saccades, fixations) and to rule out stroke-related deficits of visuospatial attention, clinical tests One day
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