Stroke Clinical Trial
Official title:
Feasibility and Practice Characteristics of FNS and Gait Robot
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).
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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