Feasibility and Practice Characteristics of FNS and Gait Robot

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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>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&#189; hrs, with the time divided into thirds as follows: 1) &#189; hr coordination exercise; 2) &#189; hr over ground gait training; and 3) &#189; 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 (&gt;6 months after the stroke).</p>\n', created = 1283568213, expire = 1283654613, headers = '', serialized = 0 WHERE cid = '1:44a9981ac2fa7449f0fe844ce3be0560' in /persistent/html/includes/cache.inc on line 109.
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  • user warning: Table './intheclinic/cache_filter' is marked as crashed and should be repaired query: UPDATE cache_filter SET data = '<p>Inclusion Criteria:\n<ul>\n<li>Greater than or equal to 6 months after stroke</li>\n<li>21 years or older</li>\n<li>Ability to follow 2 step commands</li>\n<li>Inability to move leg normally</li>\n</ul>\n</p><p> Exclusion Criteria:\n<ul>\n<li>Pacemaker</li>\n<li>Progressive medical condition (i.e. Parkinsons Disease)</li>\n</ul>\n</p>', created = 1283568213, expire = 1283654613, headers = '', serialized = 0 WHERE cid = '1:7d14d2dded5d60a44c896db43794b0e5' in /persistent/html/includes/cache.inc on line 109.
Recruitment status: 
Recruiting

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).

Background information
Trial ID: 
NCT00508755
Other unique IDs: 
B4036I
Official title: 

Feasibility and Practice Characteristics of FNS and Gait Robot

Detailed description: 

 

Number to be enrolled: 
0 patients
Clinical information
Age groups: 
Adult
Senior
Gender: 
Both
Eligibility criteria: 

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)

Study design: 
Treatment
Single Group Assignment
Open Label
Interventions: 
Gait Robot
Functional Neuromuscular stimulation with intramuscular electrodes
Conditions treated: 
Stroke
Funding
Funding types: 
U.S. FED
Sponsor: 
Department of Veterans Affairs
Dates
Date the data was first received: 
Fri, 2007-07-27
Trial start date: 
Mon, 2005-08-01
Trial completion date: 
Sat, 2009-08-01
Trial last updated: 
Tue, 2009-01-20