Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00864708

Enrollment

Registered

2009-03-19

Start date

2008-12-31

Completion date

2010-04-30

Last updated

2014-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Functional Electrical Stimulation

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.

Interventions

DEVICEradio frequency-controlled (RF) Microstimulator (RFM) Gait System

Fully Implanted FES system to assist patient with gait component practice

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Kinematic Gait Measures	Day 1 and at 3 months, following treatment	assessment of the lower limb kinematics during ambulation at chosen speed.
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.

Secondary

Measure	Time frame	Description
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)

Countries

United States

Participant flow

Recruitment details

Dec 2008 - October 2009, recruitment by flier and by word of mouth

Participants by arm

Arm	Count
Arm 1 Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )	1
Total	1

Baseline characteristics

Characteristic	Arm 1
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	1 Participants
Age, Continuous	37 years STANDARD_DEVIATION 0
Region of Enrollment United States	1 participants
Sex: Female, Male Female	1 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	1 / 1
serious Total, serious adverse events	0 / 1