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Cognitive & Motor Training After Stroke For Everyday Walking Restoration

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ClinicalTrials.gov Identifier: NCT01160653
Recruitment Status : Withdrawn (Never funded)
First Posted : July 12, 2010
Last Update Posted : February 25, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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

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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT01160653


Locations
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Janis Daly, PhD MS VA Medical Center, Cleveland

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov 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:
stroke
Gait training
Cognitive Training

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