Feasibility and Practice Characteristics of FNS and Gait Robot
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|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||Phase|
|Stroke||Device: Gait Robot Device: Functional Neuromuscular stimulation with intramuscular electrodes||Not Applicable|
|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|
|Actual Primary Completion Date :||June 2009|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|