Feasibility and Practice Characteristics of FNS and Gait Robot
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Purpose
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 | Intervention |
|---|---|
|
Stroke |
Device: Gait Robot Device: Functional Neuromuscular stimulation with intramuscular electrodes |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Feasibility and Practice Characteristics of FNS and Gait Robot |
- Gait Kinematics [ Time Frame: pre and post training ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 8 |
| Study Start Date: | August 2005 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
stroke
|
Device: Gait Robot
gait training with the use of a gait robot
Device: Functional Neuromuscular stimulation with intramuscular electrodes
gait training with use of functional electrical stimulation
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Greater than or equal to 6 months after stroke
- 21 years or older
- Ability to follow 2 step commands
- Inability to move leg normally
Exclusion Criteria:
- Pacemaker
- Progressive medical condition (i.e. Parkinsons Disease)
Contacts and Locations More Information
No publications provided by Department of Veterans Affairs
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Daly, Janis - Principal Investigator, Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00508755 History of Changes |
| Other Study ID Numbers: | B4036I |
| Study First Received: | July 27, 2007 |
| Last Updated: | April 15, 2010 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by Department of Veterans Affairs:
|
cerebrovascular accident electrical stimulation gait training motor learning |
Additional relevant MeSH terms:
|
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013