- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03025776
One vs. Two Hand Use After Stroke: Role of Task Requirements (FSIFall2016)
January 25, 2018 updated by: Maureen Whitford, Cleveland State University
To further develop interventions, the investigators need a better understanding of which task requirements (i.e.
size or weight of object, location in workspace, etc.) drive a person after stroke to use 2 hands (as opposed to 1), and how the severity of their injury impacts this relationship and compare this to reaching in age-matched healthy controls subjects.
A better understanding of this relationship will promote more informed development of rehabilitative interventions.
This study proposes to explore in people after stroke and healthy controls: i.) how specific functional tasks requirements relate to 1 vs. 2 handed use, and ii.) how stroke severity impacts this arm use.
We are proposing to study 15 individuals more than 6 months after stroke in the CSU Motor Behavior Lab for a two x 3 hour session of task-related reaching in sitting and 33 age matched (double sample size) healthy controls.
The investigators will systematically vary task requirements (i.e.
object size or weight, location in workspace, etc.), and record use of 1 versus 2 hands using videotaping as well as recording of quality of arm movement (kinematics) and muscle activity (EMG) in both arms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
48
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Cleveland, Ohio, United States
- Cleveland State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
adults > 18 years old chronic post-stroke with upper extremity paresis yet able to complete a reach-to-grasp task independently with their paretic arm healthy controls > 18 years old (as per above)
Description
Inclusion Criteria:
subjects post-stroke
- passive flexibility (i.e. passive range of motion) in both arms such that the elbows can be straightened within 15 degrees of normal and shoulders be flexed (lifted up) at least 90 degrees and the hand needs to be able to open at least 75% of the way
- Actively (of each subject's own accord/ability) they must be able to, without assist in sitting and standing: straighten each elbow within 15 degrees of full range of motion, lift each arm up at at least 60 degrees from at the side, open each hand from a gross grasp volitionally.
- able to lift a glass jar using 1 or 2 hands in sitting and standing 10" above the table top.
- able to come to CSU for two x 3 hour visits with or without assistance of their caregiver/significant other
- No arm/hand injury within the last 3 months. * Individuals with common visual deficits post-stroke (1 side partial visual field cut aka homonymous hemianopsia) will be included.
Healthy controls:
-age matched (double sample size); no known injury to arms within last 3 months, able to carry out experimental task, no neurologic diagnoses/perceptual or sensory deficits affecting arm movement
Exclusion Criteria:
- Individuals who have any additional/other neurologic condition (i.e. Parkinsons Disease, multiple sclerosis, spinal cord injury)
- severe perceptual neglect (tested using clock drawing test ).
- Any individual who cannot answer phone screen questions competently and/or follow simple 2 step commands during the in-person screen
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
stroke
individuals chronic (> 6 months) post-stroke
|
sitting reaching under various task conditions (size, speed, location)
sitting reaching under various task conditions (size, speed, location), told how many & which hand to use, kinematic data collected
|
age matched health controls
age matched (double sample size anticipated) healthy controls
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sitting reaching under various task conditions (size, speed, location)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hand Use (qualitative analysis of how many hands, which hand used) via video
Time Frame: within 1st day session only (assessed w/i 2-3 hour session only)
|
within 1st day session only (assessed w/i 2-3 hour session only)
|
|
upper extremity kinematics (peak velocity, index of curvature, total movement time)
Time Frame: within 2nd day session only (assessed w/i 2-3 hour session only)
|
measured on Day 2 session using electromagnetic sensors
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within 2nd day session only (assessed w/i 2-3 hour session only)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
December 14, 2016
First Submitted That Met QC Criteria
January 17, 2017
First Posted (Estimate)
January 20, 2017
Study Record Updates
Last Update Posted (Actual)
January 29, 2018
Last Update Submitted That Met QC Criteria
January 25, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-FY2016-332
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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