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Feasibility and Practice Characteristics of FNS and Gait Robot
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, July 2007
First Received: July 27, 2007   Last Updated: January 20, 2009   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00508755
  Purpose

Conventional therapies do not restore normal gait for many stroke survivors. The long-term goal of this work is to restore volitional lower limb motor control and gait following stroke. In our prior work, we demonstrated that it was feasible to provide a clinically operated, combined treatment of body weight supported treadmill training alone (BWSTT) + functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes (FNS-IM).

Specific Aims and Hypothesis The purpose or Specific Aim of the study is to test the feasibility and gait training potential of combining the Lokomat and FNS-IM for stroke survivors.

Given the feasibility of our clinically operated combination of BWSTT + FNS-IM, we propose to test the feasibility of the combination of Lokomat + FNS-IM. Hypothesis I. It is feasible to utilize a clinically operated combination of Lokomat + functional neuromuscular stimulation (FNS) with intramuscular (IM) electrodes (FNS-IM). Treatment Procedures. The subjects will be treated for three months, four sessions/week (for a total of 48 treatment visits). A given session will be

1½ hrs, with the time divided into thirds as follows: 1) ½ hr coordination exercise; 2) ½ hr over ground gait training; and 3) ½ hr Lokomat gait training. FNS-IM will be used in all three aspects of the protocol, unless the subject is capable of volitionally executing a given movement or gait component. Population. The subjects will be chronic stroke survivors (>6 months after the stroke).


Condition Intervention
Stroke
Device: Gait Robot
Device: Functional Neuromuscular stimulation with intramuscular electrodes

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment
Official Title: Feasibility and Practice Characteristics of FNS and Gait Robot

Further study details as provided by Department of Veterans Affairs:

Study Start Date: August 2005
Estimated Study Completion Date: August 2009
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Greater than or equal to 6 months after stroke
  • 21 years or older
  • Ability to follow 2 step commands
  • Inability to move leg normally

Exclusion Criteria:

  • Pacemaker
  • Progressive medical condition (i.e. Parkinsons Disease)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508755

Locations
United States, Ohio
Louis Stokes Cleveland Department of Veterans Affairs Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Jessica McCabe, M.P.T.     216-791-3800 ext 4691     jessicapmccabe@hotmail.com    
Contact: Janis Daly, Ph.D.     216-791-3800 ext 4129     jjd17@case.edu    
Principal Investigator: Janis J Daly, Ph.D., M.S.            
Sponsors and Collaborators
  More Information

No publications provided by Department of Veterans Affairs

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: B4036I
Study First Received: July 27, 2007
Last Updated: January 20, 2009
ClinicalTrials.gov Identifier: NCT00508755     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
gait training
motor learning
electrical stimulation
cerebrovascular accident

Study placed in the following topic categories:
Cerebral Infarction
Stroke

ClinicalTrials.gov processed this record on May 07, 2009