Clinical trial NCT00864708: Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008
Official title: Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: Functional Electrical Stimulation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: The Alfred E. Mann Foundation for Scientific Research
First posted: 2009-03-19
Enrollment: 1
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Walking Endurance (6MWT)
timeFrame: Day 1 and at 3 months, following treatment
measure: Kinematic Gait Measures
timeFrame: Day 1 and at 3 months, following treatment
Secondary outcomes:
measure: Fugl-Meyer Lower Extremity Score
timeFrame: Day 1 and at 3 months, following treatment
measure: Ashworth Scale
timeFrame: Day 1 and at 3 months, following treatment
measure: Stroke Impact Scale (SIS)
timeFrame: Day 1 and at 3 months, following treatment
measure: Manual Muscle Testing (MMT)
timeFrame: Day 1 and at 3 months, following treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: VA Medical Center, Cleveland
state: Ohio
Study officials:
affiliation: VA Medical Center-Cleveland
name: Janis Daly, PhD MS
role: PRINCIPAL_INVESTIGATOR
References: