NCT01160653

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2008

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 12, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

3 years

First QC Date

April 26, 2010

Last Update Submit

February 21, 2014

Conditions

Stroke

Keywords

strokeGait trainingCognitive Training

Outcome Measures

Primary Outcomes (1)

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

    post treatment

Study Arms (2)

1

EXPERIMENTAL

Gait training and Cognitive Training

Device: FES-IMOther: Cognitive training

2

NO INTERVENTION

Able Bodied

Interventions

FES-IMDEVICE

implantable Functional Electrical Stimulation

1
Cognitive trainingOTHER

training of impaired cognitive processes

1

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • pacemaker
  • unstable/uncontrolled medical condition(s)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Janis Daly, PhD MS

    VA Medical Center-Cleveland

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2010

First Posted

July 12, 2010

Study Start

August 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

February 25, 2014

Record last verified: 2014-02

Locations

US(1)