Functional Electrical Stimulation Mediated Neuroplasticity: Lower Extremity CCNMES in Stroke

Completed

Phase N/A Results

Trial Description

This is a small pilot randomized controlled trial which will enroll both subacute (<6 mos) and chronic (>6 mos) stroke survivors with ankle dorsiflexion weakness. The subjects will be randomized to Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES) versus control. The primary objective of this study is to compare the effect of 6-weeks of lower extremity CCNMES, applied in an anti-phase application, on motor impairment and functional mobility to a control group.

Conditions

Interventions

  • Contralaterally Controlled Neuromuscular Electrical Stimulation Device
    ARM 1: Kind: Experimental
    Label: CCNMES
    Description: Contralaterally Controlled Neuromuscular Electrical Stimulation (CCNMES): CCNMES uses electrical stimulation to move the weaker ankle up and down. The user will control the stimulation using the other (stronger) ankle. A special sock is worn on the stronger ankle. When the stronger ankle is moved, a signal is sent from a sensor on the sock to the electrical stimulator. The stimulator then sends stimulation to the weaker ankle which causes it to move. Sound and light cues coming from the stimulator will tell the user when to move the stronger ankle and when to relax.
  • Cyclic Neuromuscular Electrical Stimulation Device
    ARM 1: Kind: Experimental
    Label: Cyclic NMES
    Description: Cyclic Neuromuscular Electrical Stimulation (NMES) uses automatic, repetitive electrical stimulation to stimulate the muscles in order to move the weaker ankle up and down.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Walking Speed Baseline walking speed and change from baseline at 6 weeks (end of treatment) No
Secondary Ankle Movement Tracking Error Baseline ankle movement tracking error and change from baseline at 6 weeks (end of treatment) No
Secondary Active Range Of Motion (ROM) of Ankle Baseline active range of motion of ankle and change from baseline at 6 weeks (end of treatment) No
Secondary Fugl-Meyer Lower Extremity Motor Assessment Baseline Fugl-Meyer lower extremity motor assessment and change from baseline at 6 weeks (end of treatment) No
Secondary Modified Emory Functional Ambulation Profile (MEFAP) Baseline modified Emory functional ambulation profile and change from baseline at 6 weeks (end of treatment) No
Primary Change in Lower Extremity Fugl-Meyer Score at End of Treatment Baseline and End of Treatment (6 weeks)
Secondary Change in 10-Meter Walk Test Baseline and End of Treatment (6 weeks)
Secondary Change in Ankle Movement Tracking Error at End of Treatment Baseline and End of Treatment (6 weeks)
Secondary Change in Modified Emory Functional Ambulation Profile (MEFAP) at End of Treatment Baseline and End of Treatment (6 weeks)

Sponsors