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Cognitive & Motor Training After Stroke For Everyday Walking Restoration

Primary Purpose

Stroke

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FES-IM
Cognitive training
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, Gait training, Cognitive Training

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • greater than or equal to 6 months post stroke
  • ability to give informed consent
  • impaired gait
  • medically stable

Exclusion Criteria:

  • pacemaker
  • unstable/uncontrolled medical condition(s)

Sites / Locations

  • VA Medical Center, Cleveland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Gait training and Cognitive Training

Able Bodied

Outcomes

Primary Outcome Measures

Coordinated Components of gait using the Gait Assessment and Intervention Tool (G.A.I.T.)

Secondary Outcome Measures

Full Information

First Posted
April 26, 2010
Last Updated
February 21, 2014
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT01160653
Brief Title
Cognitive & Motor Training After Stroke For Everyday Walking Restoration
Official Title
Cognitive and Motor Training After Stroke for Everyday Walking Restoration
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Never funded
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to test a unique, combined cognitive and motor intervention designed to restore safe, more normal coordinated gait components into the real world environment for individuals with stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, Gait training, Cognitive Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Gait training and Cognitive Training
Arm Title
2
Arm Type
No Intervention
Arm Description
Able Bodied
Intervention Type
Device
Intervention Name(s)
FES-IM
Intervention Description
implantable Functional Electrical Stimulation
Intervention Type
Other
Intervention Name(s)
Cognitive training
Intervention Description
training of impaired cognitive processes
Primary Outcome Measure Information:
Title
Coordinated Components of gait using the Gait Assessment and Intervention Tool (G.A.I.T.)
Time Frame
post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: greater than or equal to 6 months post stroke ability to give informed consent impaired gait medically stable Exclusion Criteria: pacemaker unstable/uncontrolled medical condition(s)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janis Daly, PhD MS
Organizational Affiliation
VA Medical Center, Cleveland
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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Cognitive & Motor Training After Stroke For Everyday Walking Restoration

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