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Cognitive & Motor Training After Stroke For Everyday Walking Restoration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01160653
Recruitment Status : Withdrawn (Never funded)
First Posted : July 12, 2010
Last Update Posted : February 25, 2014
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

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.

Condition or disease Intervention/treatment Phase
Stroke Device: FES-IM Other: Cognitive training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive and Motor Training After Stroke for Everyday Walking Restoration
Study Start Date : August 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Arm Intervention/treatment
Experimental: 1
Gait training and Cognitive Training
Device: FES-IM
implantable Functional Electrical Stimulation

Other: Cognitive training
training of impaired cognitive processes

No Intervention: 2
Able Bodied

Primary Outcome Measures :
  1. Coordinated Components of gait using the Gait Assessment and Intervention Tool (G.A.I.T.) [ Time Frame: post treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01160653

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United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
US Department of Veterans Affairs
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Principal Investigator: Janis Daly, PhD MS VA Medical Center, Cleveland

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Responsible Party: US Department of Veterans Affairs Identifier: NCT01160653     History of Changes
Other Study ID Numbers: UNF1
First Posted: July 12, 2010    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: February 2014

Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
Gait training
Cognitive Training

Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases