NCT03135093

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 1, 2017

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

February 11, 2020

Status Verified

January 1, 2020

Enrollment Period

2.7 years

First QC Date

April 26, 2017

Last Update Submit

February 6, 2020

Conditions

Keywords

synergiesupper limbvision

Outcome Measures

Primary Outcomes (2)

  • Upper limb movement quality

    Fugl-Meyer Assessment of the upper extremity (FMA-UE), kinematic data (e.g. joint angles, hand workspace)

    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

    One day

Study Arms (2)

Stroke subjects

Other: No intervention

Healthy subjects

Other: No intervention

Interventions

No Intervention

Healthy subjectsStroke subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke subjects

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

cereneo Schweiz AG

Vitznau, Canton of Lucerne, 6345, Switzerland

Location

Related Publications (2)

  • 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.

  • Schwarz 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.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2017

First Posted

May 1, 2017

Study Start

April 1, 2017

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

February 11, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will share

The anonymized project data will be shared within the partners of the European Horizon2020 - SoftPro (No.688857) project.

Locations