NCT03025776

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

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

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 29, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

December 14, 2016

Last Update Submit

January 25, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Hand Use (qualitative analysis of how many hands, which hand used) via video

    within 1st day session only (assessed w/i 2-3 hour session only)

  • upper extremity kinematics (peak velocity, index of curvature, total movement time)

    measured on Day 2 session using electromagnetic sensors

    within 2nd day session only (assessed w/i 2-3 hour session only)

Study Arms (2)

stroke

individuals chronic (\> 6 months) post-stroke

Behavioral: ReachingBehavioral: Kinematic collection while reaching

age matched health controls

age matched (double sample size anticipated) healthy controls

Behavioral: Reaching

Interventions

ReachingBEHAVIORAL

sitting reaching under various task conditions (size, speed, location)

age matched health controlsstroke

sitting reaching under various task conditions (size, speed, location), told how many \& which hand to use, kinematic data collected

stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland State University

Cleveland, Ohio, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 14, 2016

First Posted

January 20, 2017

Study Start

September 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 29, 2018

Record last verified: 2018-01

Locations