Stroke Clinical Trial
Official title:
Assessing Pathological Synergies of Upper Limb Function and the Relationship to Visuospatial Exploration After Stroke
| 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 |
| Verified date | January 2020 |
| Source | University of Zurich |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | cereneo Schweiz AG | Vitznau | Luzern |
| Lead Sponsor | Collaborator |
|---|---|
| University of Zurich |
Switzerland,
| 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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