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Feasibility and Practice Characteristics of FNS and Gait Robot

NCT00508755 · US Department of Veterans Affairs · Updated 25 April 2014

What is being tested
Gait Robot; Functional Neuromuscular stimulation with intramuscular electrodes
For
Stroke
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 21 years and older. About 6 people. The full rules are on the registry page.
Where
United States
When
Starts or started Aug 2005, ends Aug 2009. Registered 30 July 2007.
Results
Posted on the registry on 2 April 2014.

In the researchers' words

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…
ClinicalTrials.gov, NCT00508755

Sites

  • VA Medical Center, ClevelandCleveland, Ohio, United States