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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00508755 |
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
1½ hrs, with the time divided into thirds as follows: 1) ½ hr coordination exercise; 2) ½ hr over ground gait training; and 3) ½ 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 | Intervention |
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Stroke |
Device: Gait Robot Device: Functional Neuromuscular stimulation with intramuscular electrodes |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | Feasibility and Practice Characteristics of FNS and Gait Robot |
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
Louis Stokes Cleveland Department of Veterans Affairs Medical Center | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Jessica McCabe, M.P.T. 216-791-3800 ext 4691 jessicapmccabe@hotmail.com | |
Contact: Janis Daly, Ph.D. 216-791-3800 ext 4129 jjd17@case.edu | |
Principal Investigator: Janis J Daly, Ph.D., M.S. |
Study ID Numbers: | B4036I |
Study First Received: | July 27, 2007 |
Last Updated: | January 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00508755 History of Changes |
Health Authority: | United States: Food and Drug Administration |
gait training motor learning electrical stimulation cerebrovascular accident |
Cerebral Infarction Stroke |