- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07254949
Vision and Proprioception Evaluation With Robotics After Stroke (VIPERS)
Stroke is highly prevalent in Canada and can lead to profound upper limb impairments in motor and sensory function, as well and vision. Clinical assessments for these functions often lack sensitivity making detecting impairments and tracking their recovery after stroke difficult. It is known that sensory function and vision interact to inform motor behaviours, yet how each of these modalities might contribute to motor impairments and subsequent recovery after stroke is undetermined.
Using robotics to assess neurologic function after a stroke can be very beneficial, as they can measure on the scale of millimetres and milliseconds which can more easily detect subtle deficits in a persons function. Compared to current clinical tools, robotics offer greater objectivity and reliability, as they do not rely on the examiners clinical experience and/or impression. The use of robotics not only offers a more precise measurement, but robotics assessments can be completed in a relatively short amount of time, in comparison to some of the current clinical assessment tools, which can take along time to complete. In addition to robotics, collecting neuroimaging (MRI/CT) will allow us to relate our robotic and eye-tracking measures to neuroanatomical information about the person's stroke. With this data, we will assess how the brain changes post-stroke in relation to the recovery of motor, sensory and visual functions.
This research will: 1) examine the relationship between visual and proprioceptive impairment on motor and eye movement behaviour over time after stroke, and 2) identify neuroanatomical correlates of visual, proprioceptive and sensory integrative dysfunction that impact motor recovery after stroke and examine the ability of regional damage and network disruption to predict recovery.
Objectives:
- Determine the impact of visual field loss and visual neglect in stroke survivors with impaired movement over the first 6 months post-stroke.
- Identify the impact of Proprioceptive Impairment and Sensory Integration Impairment on recovery post-stroke using robotics and eye tracking.
- Understand the impact of damage to neuroanatomic structures involved in vision, proprioception and sensory integration on motor recovery using MRI after stroke.
The VIPERS study is recruiting both stroke and control participants. Stroke participants are recruited within the first 28 days post-stroke and are assessed longitudinally across the first 6-months post-stroke (four study timepoints). Control participants just complete a single session.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada
- Foothills Medical Centre
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Contact:
- Rachel Stone
- Phone Number: 403-944-4050
- Email: robotlab@ucalgary.ca
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Calgary, Alberta, Canada
- Carewest Dr. Vernon Fanning Centre
-
Contact:
- Rachel Stone
- Phone Number: 403-944-4050
- Email: robotlab@ucalgary.ca
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria for stroke participants:
- 18 years of age or older
- First clinical diagnosis of stroke
- No recent muscle skeletal injuries to the arms, neck, or back
- No history of other neurological disease/injury (Ie. MS, Parkinson's, Brain Tumour, etc.)
- Corrected vision 20/50 or better
- Able to follow multi-step commands.
- Living independently prior to stroke
- Can consent to participate in research
Inclusion criteria for control participants:
- 18 years of age or older
- No history stroke, or Trans Ischemic Attack (TIA)
- No recent muscle skeletal injures to the arms, neck, or back
- No history of other neurological disease/ injury (Ie. MS, Parkinson's, Brain Tumour, etc)
- No pre-stroke history of eye movement disorders
- Corrected vision 20/50 or better
- Able to follow multi-step commands
- Can consent to participate in research
Exclusion Criteria:
- Prior history of stroke/significant neurologic problem (e.g. Parkinson's)
- Symptomatic medical conditions that would interfere with participation (e.g. uncontrolled angina)
- Contraindications to Magnetic Resonance Imaging (MRI)
- Pre-stroke history of visual field/oculomotor abnormalities.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Stroke
Stroke Participants - Individuals with first time stroke
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Control
Control Participants - Individuals not suffering stroke or other neurological disorders
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Visually Guided Reaching Score
Time Frame: Enrolment to six-months post stroke
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Enrolment to six-months post stroke
|
Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Visually Guided Reaching Score (no vision)
Time Frame: Enrolment to six-months post stroke
|
Enrolment to six-months post stroke
|
|
Proprioceptive Saccade task scores
Time Frame: Enrolment to six-months post stroke
|
Enrolment to six-months post stroke
|
|
Arm Movement Matching (vision)
Time Frame: Enrolment to six-months post stroke
|
Enrolment to six-months post stroke
|
|
Arm Movement Matching
Time Frame: Enrolment to six-months post stroke
|
Enrolment to six-months post stroke
|
|
Arm position matching (vision)
Time Frame: Enrolment to six-months post stroke
|
Enrolment to six-months post stroke
|
|
Arm Position Matching Score
Time Frame: Enrolment to six-months post stroke
|
Enrolment to six-months post stroke
|
|
Visually Guided Reaching Score
Time Frame: From enrolment to six-months post stroke
|
From enrolment to six-months post stroke
|
|
Anti-saccade task score
Time Frame: Enrolment to six-months post stroke
|
Enrolment to six-months post stroke
|
|
Pro-saccade task score
Time Frame: Enrolment to six-months post-stroke
|
Enrolment to six-months post-stroke
|
|
Behavioural Inattention Test (BIT)
Time Frame: Enrolment to six-months post-stroke
|
Enrolment to six-months post-stroke
|
|
Visual Impairment Screening Assessment (VISA)
Time Frame: Enrolment to six-months post-stroke
|
Enrolment to six-months post-stroke
|
|
Humphrey's Visual Field Analyzer (VFA)
Time Frame: Enrolment to six-months post stroke
|
Enrolment to six-months post stroke
|
|
Thumb Localization Test (TLT)
Time Frame: Enrolment to six-months post stroke
|
Enrolment to six-months post stroke
|
|
Medical Research Council Strength Scale
Time Frame: Enrolment to six-months post stroke
|
Enrolment to six-months post stroke
|
|
Modified Ashworth Scale (MAS)
Time Frame: Enrolment to six-months post stroke
|
Enrolment to six-months post stroke
|
|
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)
Time Frame: Enrolment to six-months post stroke
|
Enrolment to six-months post stroke
|
|
Functional Independence Measure (FIM)
Time Frame: Enrolment to six-months post stroke
|
Enrolment to six-months post stroke
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB25-1170
- 197953 (Other Grant/Funding Number: Canadian Institutes of Health Research)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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