Feasibility and Practice Characteristics of FNS and Gait Robot

Completed

Phase N/A Results

Trial Description

Conventional therapies do not restore normal gait for many stroke survivors. The long-term goal of this work is to restore volitional lower limb motor control and gait following stroke. In our prior work, we demonstrated that it was feasible to provide a clinically operated, combined treatment of body weight supported treadmill training alone (BWSTT) + functional neuromuscular stimulation (FNS) using intramuscular (IM) electrodes (FNS-IM).
Specific Aims and Hypothesis The purpose or Specific Aim of the study is to test the feasibility and gait training potential of combining the Lokomat and FNS-IM for stroke survivors. Given the feasibility of our clinically operated combination of BWSTT + FNS-IM, we propose to test the feasibility of the combination of Lokomat + FNS-IM.
Hypothesis I. It is feasible to utilize a clinically operated combination of Lokomat + functional neuromuscular stimulation (FNS) with intramuscular (IM) electrodes (FNS-IM).
Treatment Procedures. The subjects will be treated for three months, four sessions/week (for a total of 48 treatment visits). A given session will be 1 hrs, with the time divided into thirds as follows: 1) hr coordination exercise; 2) hr over ground gait training; and 3) hr Lokomat gait training. FNS-IM will be used in all three aspects of the protocol, unless the subject is capable of volitionally executing a given movement or gait component. Population. The subjects will be chronic stroke survivors (>6 months after the stroke).

Conditions

Interventions

  • Functional Neuromotor Stimulation Behavioral
    Intervention Desc: FNS systems include (1) electrodes taped to the skin, inserted through the skin, or surgically implanted, (2) a control unit (microprocessor) to trigger and modulate the intensity of the electrical stimuli, and (3) a stimulator to generate the electrical pulse.
  • Gait Robot Device
    Intervention Desc: gait training with the use of a gait robot
    ARM 1: Kind: Experimental
    Label: 1
    Description: stroke
    ARM 2: Kind: Experimental
    Label: Arm 1
    Description: stroke
  • Functional Neuromuscular stimulation with intramuscular electrodes Device
    Intervention Desc: gait training with use of functional electrical stimulation
    ARM 1: Kind: Experimental
    Label: 1
    Description: stroke
    ARM 2: Kind: Experimental
    Label: Arm 1
    Description: stroke

Trial Design

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

Patient Involvement

The subjects will be treated for three months, four sessions/week (for a total of 48 treatment visits). A given session will be 1 hrs, with the time divided into thirds as follows: 1) hr coordination exercise; 2) hr over ground gait training; and 3) hr Lokomat gait training. FNS-IM will be used in all three aspects of the protocol, unless the subject is capable of volitionally executing a given movement or gait component

Outcomes

Type Measure Time Frame Safety Issue
Primary Gait Kinematics
Primary Observational Gait Components: Observational Comparison of Gait Components for: Gait Robot-alone Condition, FES-alone Condition, and Combined Gait Robot and FES. visit 48, following treatment No

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