NCT03364374

Brief Summary

This study evaluates the relationship between seated posture and fine motor performance in a drawing task in people with stroke and in healthy control subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

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

February 4, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 6, 2017

Completed
Last Updated

December 6, 2017

Status Verified

December 1, 2017

Enrollment Period

1.4 years

First QC Date

November 27, 2017

Last Update Submit

December 5, 2017

Conditions

Keywords

Stroke rehabilitationUpper extremityPosture

Outcome Measures

Primary Outcomes (1)

  • Change in tracing smoothness from baseline to after postural counseling

    Change in the average jerk of the hand trajectory during a tracing task

    Within 24 hours

Secondary Outcomes (1)

  • Change in center of pressure displacement from baseline to after postural counseling

    Within 24 hours

Study Arms (2)

Stroke survivors

Individuals that experienced uni-hemispheric ischemic or hemorrhagic stroke

Behavioral: Postural counseling

Controls

Healthy controls with no history of stroke

Behavioral: Postural counseling

Interventions

A therapist will provide verbal/physical cues to improve the participants posture

ControlsStroke survivors

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke patients will be recruited from the MUSC Center for Rehabilitation Research in Neurological Conditions database (approved IRB PRO# 15991, PI Kautz) that currently contains contact information for \~120 stroke survivors who have agreed to be contacted for research participation.

You may qualify if:

  • experienced uni-hemispheric ischemic or hemorrhagic stroke 3 mo - 7 yrs prior
  • ability to grasp and hold a stylus for the duration of the experiments
  • passive motion throughout the paretic UE within 20° of normal
  • dominant side affected

You may not qualify if:

  • lesion in brainstem or cerebellum
  • presence of other neuro-disease impairing motor skills
  • unable to understand 3-step directions
  • pain, orthopedic condition or impaired corrected vision that would alter reaching
  • Healthy Controls:
  • no history of stroke or incomplete spinal cord injury
  • no medical, orthopedic, neurological, or uncorrected visual condition that would limit the ability to participate in upper extremity testing
  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Christian Finetto, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-doctoral Scholar

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 6, 2017

Study Start

February 4, 2015

Primary Completion

July 5, 2016

Study Completion

July 5, 2016

Last Updated

December 6, 2017

Record last verified: 2017-12

Locations