Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

This study has been terminated.
(The enrollment period/study duration had exceeded The Alfred Mann Foundation's timeline.)
Sponsor:
Collaborator:
The Alfred E. Mann Foundation for Scientific Research
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00864708
First received: March 17, 2009
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Stroke
Device: radio frequency-controlled (RF) Microstimulator (RFM) Gait System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Walking Endurance (6MWT) [ Time Frame: Day 1 and at 3 months, following treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    assessment of the lower limb kinematics during ambulation at chosen speed.


Secondary Outcome Measures:
  • Fugl-Meyer Lower Extremity Score [ Time Frame: Day 1 and at 3 months, following treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)


Enrollment: 1
Study Start Date: December 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00864708

Locations
United States, Ohio
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
The Alfred E. Mann Foundation for Scientific Research
Investigators
Principal Investigator: Janis Daly, PhD MS VA Medical Center, Cleveland
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00864708     History of Changes
Other Study ID Numbers: B3252-R, B3513R
Study First Received: March 17, 2009
Results First Received: November 25, 2013
Last Updated: May 7, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
Functional Electrical Stimulation

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 21, 2014