Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

Not Applicable

Terminated

Interventions: Device: radio frequency-controlled (RF) Microstimulator (RFM) Gait System

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

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Arm 1	radio frequency-controlled (RF) Microstimulator (RFM) Gait System	radio frequency-controlled (RF) Microstimulator (RFM) Gait System

Primary Outcome Measures

Name	Time	Method
Walking Endurance (6MWT)	Day 1 and at 3 months, following treatment	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.
Kinematic Gait Measures	Day 1 and at 3 months, following treatment	assessment of the lower limb kinematics during ambulation at chosen speed.

Secondary Outcome Measures

Name	Time	Method
Fugl-Meyer Lower Extremity Score	Day 1 and at 3 months, following treatment	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).
Ashworth Scale	Day 1 and at 3 months, following treatment	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)
Stroke Impact Scale (SIS)	Day 1 and at 3 months, following treatment	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).
Manual Muscle Testing (MMT)	Day 1 and at 3 months, following treatment	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)