Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

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

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: Device: radio frequency-controlled (RF) Microstimulator (RFM) Gait System

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • VA Medical Center, Cleveland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Collaborators: The Alfred E. Mann Foundation for Scientific Research

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: March 17, 2009
• First Submitted That Met QC Criteria: March 18, 2009
• First Posted (Estimate): March 19, 2009

Study Record Updates

• Last Update Posted (Estimate): May 26, 2014
• Last Update Submitted That Met QC Criteria: May 7, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Functional Electrical Stimulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: B3252-R; B3513R (Other Grant/Funding Number: Department of Veterans Affairs)