Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008
|ClinicalTrials.gov Identifier: NCT00864708|
Recruitment Status : Terminated (The enrollment period/study duration had exceeded The Alfred Mann Foundation's timeline.)
First Posted : March 19, 2009
Results First Posted : May 26, 2014
Last Update Posted : May 26, 2014
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: radio frequency-controlled (RF) Microstimulator (RFM) Gait System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Experimental: Arm 1
radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Device: radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Fully Implanted FES system to assist patient with gait component practice
- Walking Endurance (6MWT) [ Time Frame: 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 [ Time Frame: Day 1 and at 3 months, following treatment ]assessment of the lower limb kinematics during ambulation at chosen speed.
- Fugl-Meyer Lower Extremity Score [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00864708
|United States, Ohio|
|VA Medical Center, Cleveland|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Janis Daly, PhD MS||VA Medical Center, Cleveland|