NCT00508755

Feasibility and Practice Characteristics of FNS and Gait Robot

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: US Department of Veterans Affairs · Federal
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Stroke

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-08-01
• Primary completion: 2009-06-01
• Completion: 2009-08-01
• First posted: 2007-07-30
• Last updated: 2014-04-25
• Results posted: 2014-04-02

Locations

1 site across 1 country: United States