Cognitive & Motor Training After Stroke For Everyday Walk... | NCT01160653

Studies
Cognitive & Motor Training After Stroke For Everyday Walking Restoration

NCT01160653

Sponsor

US Department of Veterans Affairs

Status

Withdrawn

Last Update Posted

Feb 25, 2014Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Stroke

Interventions

FES-IM
Cognitive training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Never funded

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Apr 26, 2010

First Submission Date that Met QC Criteria

Jul 8, 2010

First Posted Date

Jul 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2014

Last Update Posted Date

Feb 25, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Gait training and Cognitive Training	Device: FES-IM Other: Cognitive training
2	No Intervention	Able Bodied

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FES-IM	Device	implantable Functional Electrical Stimulation	1
Cognitive training

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Coordinated Components of gait using the Gait Assessment and Intervention Tool (G.A.I.T.)		post treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Janis Daly, PhD MS	VA Medical Center-Cleveland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Medical Center, Cleveland		Cleveland	Ohio	44106	United States

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000091942	Cognitive Training

Ancestor Terms

ID	Term
D000066530	Neurological Rehabilitation
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided