Feasibility and Practice Characteristics of FNS and Gait Robot
|ClinicalTrials.gov Identifier: NCT00508755|
Recruitment Status : Completed
First Posted : July 30, 2007
Results First Posted : April 2, 2014
Last Update Posted : April 25, 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 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)|
|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|
Experimental: Arm 1
Device: Gait Robot
gait training with the use of a gait robotDevice: Functional Neuromuscular stimulation with intramuscular electrodes
gait training with use of functional electrical stimulation
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508755
|United States, Ohio|
|VA Medical Center, Cleveland|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Janis Daly, PhD MS||VA Medical Center, Cleveland|