StrokeNCT03135093
Upper Limb Function and Visuospatial Exploration After Stroke
An observational study of Stroke, run by University of Zurich at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2017to 30 Dec 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Stroke subjects
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Pathological Synergies of Upper Limb Function and the Relationship to Visuospatial Exploration After Stroke
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.
- Conditions
- Stroke
- Being tested
- No intervention
- Keywords
- synergies, upper limb, vision
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Stroke subjects | Not described Receives: Other: No intervention | |
| Healthy subjects | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper limb movement quality
Fugl-Meyer Assessment of the upper extremity (FMA-UE), kinematic data (e.g. joint angles, hand workspace)
Measured: One day
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
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start1 Apr 2017
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135093
- Sponsor's protocol ID
- 2016-02075
- Other IDs
- 2016
- Status last verified
- Jan 2020
- First submitted
- 26 Apr 2017
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymized project data will be shared within the partners of the European Horizon2020 - SoftPro (No.688857) project.
Publications
Schwarz A, Bhagubai MMC, Nies SHG, Held JPO, Veltink PH, Buurke JH, Luft AR. Characterization of stroke-related upper limb motor impairments across various upper limb activities by use of kinematic core set measures. J Neuroeng Rehabil. 2022 Jan 12;19(1):2. doi: 10.1186/s12984-021-00979-0.
PubMed 35016694Schwarz A, Veerbeek JM, Held JPO, Buurke JH, Luft AR. Measures of Interjoint Coordination Post-stroke Across Different Upper Limb Movement Tasks. Front Bioeng Biotechnol. 2021 Jan 28;8:620805. doi: 10.3389/fbioe.2020.620805. eCollection 2020.
PubMed 33585418
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Pathological Synergies of Upper Limb Function and the Relationship to Visuospatial Exploration After Stroke
- ClinicalTrials.gov ID
- NCT03135093
- Acronym / sponsor ID
- 2016-02075
- Conditions
- Stroke
- Keywords
- synergies, upper limb, vision
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 1 May 2017 (actual)
- 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke subjects | – | Other: No intervention |
| Healthy subjects | – | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke subjects
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo Intervention | Other | Healthy subjects, Stroke subjects |
Primary outcome
Upper limb movement quality
Time frame: One day
Fugl-Meyer Assessment of the upper extremity (FMA-UE), kinematic data (e.g. joint angles, hand workspace)
Visuospatial exploration
Time frame: One day
Eye-tracking data (e.g. area of interest, eye movements: saccades, fixations) and to rule out stroke-related deficits of visuospatial attention, clinical tests
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 11 Feb 2020.
- Derived from this study: PubMed 35016694Schwarz A, Bhagubai MMC, Nies SHG, Held JPO, Veltink PH, Buurke JH, Luft AR. Characterization of stroke-related upper limb motor impairments across various upper limb activities by use of kinematic core set measures. J Neuroeng Rehabil. 2022 Jan 12;19(1):2. doi: 10.1186/s12984-021-00979-0.
- Derived from this study: PubMed 33585418Schwarz A, Veerbeek JM, Held JPO, Buurke JH, Luft AR. Measures of Interjoint Coordination Post-stroke Across Different Upper Limb Movement Tasks. Front Bioeng Biotechnol. 2021 Jan 28;8:620805. doi: 10.3389/fbioe.2020.620805. eCollection 2020.
- Individual participant dataSharing planned: Yes. The anonymized project data will be shared within the partners of the European Horizon2020 - SoftPro (No.688857) project.
Related trials for Stroke
Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
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 4 inclusion and 6 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 11 Feb 2020. 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?
Upper limb movement quality (time frame: One day). The study lists 2 primary outcomes in all. 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 NCT03135093, which also lists 2 linked publications.
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 11 Feb 2020.