Enhancing Function Using the RF Microstimulator Gait System Following Stroke 2008

Terminated

Phase N/A Results

Trial Description

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.

Trial Stopped: The enrollment period/study duration had exceeded The Alfred Mann Foundation's timeline.

Conditions

Interventions

  • Radio frequency-controlled (RF) Microstimulator (RFM) Gait System Device
    Intervention Desc: Fully Implanted FES system to assist patient with gait component practice
    ARM 1: Kind: Experimental
    Label: 1
    Description: radio frequency-controlled (RF) Microstimulator (RFM) Gait System
    ARM 2: Kind: Experimental
    Label: Arm 1
    Description: radio frequency-controlled (RF) Microstimulator (RFM) Gait System

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Kinematic swing phase gait components and walking endurance months 1, 3, 6 and at follow-up No
Primary Walking Endurance (6MWT) Day 1 and at 3 months, following treatment No
Primary Kinematic Gait Measures Day 1 and at 3 months, following treatment No
Secondary Fugl-Meyer Lower Extremity Score Day 1 and at 3 months, following treatment No
Secondary Ashworth Scale Day 1 and at 3 months, following treatment No
Secondary Stroke Impact Scale (SIS) Day 1 and at 3 months, following treatment No
Secondary Manual Muscle Testing (MMT) Day 1 and at 3 months, following treatment No

Sponsors