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| ID | Type | Description | Link |
|---|---|---|---|
| B3513R | Other Grant/Funding Number | Department of Veterans Affairs |
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The enrollment period/study duration had exceeded The Alfred Mann Foundation's timeline.
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| Name | Class |
|---|---|
| The Alfred E. Mann Foundation for Scientific Research | OTHER |
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The purpose of the study is to investigate new Technology for recovery of ankle walking function after stroke.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | radio frequency-controlled (RF) Microstimulator (RFM) Gait System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radio frequency-controlled (RF) Microstimulator (RFM) Gait System | Device | Fully Implanted FES system to assist patient with gait component practice |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janis Daly, PhD MS | VA Medical Center-Cleveland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Cleveland | Cleveland | Ohio | 44106 | United States |
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Dec 2008 - October 2009, recruitment by flier and by word of mouth
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This was a feasibility study to test an RFM Gait System for re-training gait coordination. Number of participants was limited to sponsor timeline.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System ) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | feet | Day 1 and at 3 months, following treatment |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System ) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| delivery of unactivated stimuli (within comfort) | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | RFM system delivered unactivated stimuli (always reported within comfort) to subject unpredictably at times when system was powered up. AMF submitted device re-test data and reports to FDA which then re-approved continued use of the RFM system. |
Study sponsor, Alfred Mann foundation (AMF) stopped study because "enrollment period/study duration has exceeded the AMF's timeline".
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janis Daly, Ph.D., M.S.; Director, Brain Rehabilitation Research Center of Excellence | NF/SG VA Medical Center, Gainesville Florida | (352) 376-1611 | 5223 | janis.daly@neurology.ufl.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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 |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | 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). | Posted | Number | units on a scale | Day 1 and at 3 months, following treatment |
|
|
|
| Secondary | 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) | Posted | Number | units on a scale | Day 1 and at 3 months, following treatment |
|
|
|
| Secondary | 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). | Posted | Number | units on a scale | Day 1 and at 3 months, following treatment |
|
|
|
| Secondary | 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) | Posted | Number | units on a scale | Day 1 and at 3 months, following treatment |
|
|
|
| Primary | Kinematic Gait Measures | assessment of the lower limb kinematics during ambulation at chosen speed. | Posted | Number | percentage of change Day 1 to 3 months | Day 1 and at 3 months, following treatment |
|
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| 0 |
| 1 |
| 1 |
| 1 |
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Principal Investigators are employed by the Department of Veterans Affairs (DVA) which funded the study; the Alfred P. Mann Foundation (AMF) provided the technology that was tested.
There was an agreement between the Principal Investigators of the DVA and the AMF that the AMF would be provided a period of time to review any manuscript for publication and provide input. There was no restriction regarding PI's rights to discuss or publish the results.
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |