Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

Study Overview
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Brief Summary
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The purpose of the study is to investigate new Technology for recovery of ankle walking function after stroke.

Detailed Description
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Background and Purpose: Conventional rehabilitation does not restore normal, upper limb function or normal gait to many stroke survivors. Functional neuromuscular stimulation (FNS) has shown promise for functional enhancement of both upper and lower limb motor control following stroke. Gains included muscle activation latencies, strength, coordination, upper limb functional tasks, gait kinematics, walking endurance, and quality of life. The purpose of the proposed work is to test the radio frequency-controlled (RF) Microstimulator (RFM) Gait System regarding system performance and subject response to treatment. Methods: This is a feasibility study in which up to four subjects will receive the (RFM) Gait System. Up to ten RFMs will be placed for a given subject. An RFM ankle muscle system will be used to train ankle gait components. A separate RFM system will be used to train knee gait components. Subjects will be treated for 6 months, four sessions/wk. Primary outcome measures for the RFM Gait System will be: kinematic swing phase gait components and walking endurance. Secondary outcome measures will include: strength, coordination, spasticity, function, and quality of life. Data collections will occur at months 1, 3 and 6, and for follow-up times up to a year after the end of treatment. The results of the RFM ankle system have the potential to provide a new technology for ankle muscle gait components.

Official Title
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Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

Conditions
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Stroke

Intervention / Treatment
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* Device: radio frequency-controlled (RF) Microstimulator (RFM) Gait System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sufficient endurance to participate in rehabilitation sessions. Medically Stable Age >21 years. Inability to perform normal ankle coordinated gait components. Participants should be able to walk and keep balance without physical assistance from another person Exclusion Criteria: Acute or progressive cardiac, renal, respiratory, neurological disorders or malignancy. Lower motor neuron damage or radiculopathy Allergy or contraindication to anesthesia, Versed, (or comparable substitute. Active implantable device (e.g. pacemaker, implantable cardiac defibrillator, neurostimulator, or drug infusion device. Pregnancy

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>radio frequency-controlled (RF) Microstimulator (RFM) Gait System | Device: radio frequency-controlled (RF) Microstimulator (RFM) Gait System<br>* Fully Implanted FES system to assist patient with gait component practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking Endurance (6MWT) | The Six Minute Walk Test (6MWT) is a measure of the distance measured in feet ambulated by the participant during six minutes. A further distance walked in 6 minutes indicates improvement on the measure. | Day 1 and at 3 months, following treatment | 
| Kinematic Gait Measures | assessment of the lower limb kinematics during ambulation at chosen speed. | Day 1 and at 3 months, following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Lower Extremity Score | Fugl-Meyer Lower Extremity Score (FMLE) is an itemized measure of lower extremity coordination following stroke. Scores for the FMLE range from 0 (most impaired) to 34 (normal). | Day 1 and at 3 months, following treatment | 
| Ashworth Scale | The Ashworth Scale is a measure of muscle spasticity; muscle groups are graded from 0 (no spasticity) to 4 (greatest spasticity/contracture). The lower limb muscle groups are summed for a total lower limb Ashworth score. A lower score indicates better performance. (range is 0-40) | Day 1 and at 3 months, following treatment | 
| Stroke Impact Scale (SIS) | The SIS is a measure of Quality of Life/Life Role Participation following stroke. Each item in a domain is scored between 0 and 5. A higher score indicates better performance (range 0-295). | Day 1 and at 3 months, following treatment | 
| Manual Muscle Testing (MMT) | This is a measure of strength of the various muscle groups of the lower limb. Each is graded on a 0 to 5 scale; the final score is the summed total of the lower limb muscle groups tested. (score range of summed muscles is 0-50, with 50 being the maximum highest score) | Day 1 and at 3 months, following treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional Electrical Stimulation