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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01160653
Other study ID # UNF1
Secondary ID
Status Withdrawn
Phase N/A
First received April 26, 2010
Last updated February 21, 2014
Start date August 2008
Est. completion date August 2011

Study information

Verified date February 2014
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2011
Est. primary completion date August 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 21 Years and older
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
FES-IM
implantable Functional Electrical Stimulation
Other:
Cognitive training
training of impaired cognitive processes

Locations

Country Name City State
United States VA Medical Center, Cleveland Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Coordinated Components of gait using the Gait Assessment and Intervention Tool (G.A.I.T.) post treatment No
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