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

March 17, 2009
May 7, 2014
December 2008
April 2010   (final data collection date for primary outcome measure)
  • 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.
Kinematic swing phase gait components and walking endurance [ Time Frame: months 1, 3, 6 and at follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00864708 on ClinicalTrials.gov Archive Site
  • 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)
Not Provided
Not Provided
Not Provided
 
Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008
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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stroke
Device: radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Fully Implanted FES system to assist patient with gait component practice
Experimental: Arm 1
radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Intervention: Device: radio frequency-controlled (RF) Microstimulator (RFM) Gait System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00864708
B3252-R, B3513R
Yes
Department of Veterans Affairs
Department of Veterans Affairs
The Alfred E. Mann Foundation for Scientific Research
Principal Investigator: Janis Daly, PhD MS VA Medical Center, Cleveland
Department of Veterans Affairs
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP