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Feasibility and Practice Characteristics of FNS and Gait Robot

This study has been completed.
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: July 27, 2007
Last updated: April 8, 2014
Last verified: April 2014

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility and Practice Characteristics of FNS and Gait Robot

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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.

Enrollment: 6
Study Start Date: August 2005
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00508755

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

Responsible Party: VA Office of Research and Development Identifier: NCT00508755     History of Changes
Other Study ID Numbers: B4036-I
Study First Received: July 27, 2007
Results First Received: October 18, 2013
Last Updated: April 8, 2014

Keywords provided by VA Office of Research and Development:
cerebrovascular accident
electrical stimulation
gait training
motor learning processed this record on May 24, 2017