Feasibility and Practice Characteristics of FNS and Gait Robot

Study Overview
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Brief Summary
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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).

Official Title
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Feasibility and Practice Characteristics of FNS and Gait Robot

Conditions
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Stroke

Intervention / Treatment
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* Device: Gait Robot
* Device: Functional Neuromuscular stimulation with intramuscular electrodes


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>stroke | Device: Gait Robot<br>* gait training with the use of a gait robot<br>Device: Functional Neuromuscular stimulation with intramuscular electrodes<br>* gait training with use of functional electrical stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. | 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. | visit 48, following treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebrovascular accident, electrical stimulation, gait training, motor learning