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Feasibility and Practice Characteristics of FNS and Gait Robot

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ClinicalTrials.gov Identifier: NCT00508755
Recruitment Status : Completed
First Posted : July 30, 2007
Results First Posted : April 2, 2014
Last Update Posted : April 25, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:

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 1 hrs, with the time divided into thirds as follows: 1) hr coordination exercise; 2) hr over ground gait training; and 3) 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 or disease Intervention/treatment
Stroke Device: Gait Robot Device: Functional Neuromuscular stimulation with intramuscular electrodes

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Practice Characteristics of FNS and Gait Robot
Study Start Date : August 2005
Primary Completion Date : June 2009
Study Completion Date : August 2009

Arm Intervention/treatment
Experimental: Arm 1
stroke
Device: Gait Robot
gait training with the use of a gait robot
Device: Functional Neuromuscular stimulation with intramuscular electrodes
gait training with use of functional electrical stimulation



Primary Outcome Measures :
  1. Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. [ Time Frame: visit 48, following treatment ]
    Observational Gait components during stance and swing phase, for pelvis, hip, knee, and ankle for each of the six participants was observed during the following conditions: Gait Robot-alone, FES-alone, and combined Gait Robot and FES.



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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

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): NCT00508755


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

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00508755     History of Changes
Other Study ID Numbers: B4036-I
First Posted: July 30, 2007    Key Record Dates
Results First Posted: April 2, 2014
Last Update Posted: April 25, 2014
Last Verified: April 2014

Keywords provided by VA Office of Research and Development:
cerebrovascular accident
electrical stimulation
gait training
motor learning