WalkAide Compared to Ankle-Foot Orthosis (AFO) in Stroke Patients

Completed

Phase N/A Results

Trial Description

To establish equivalence or incremental benefit to standard of care Ankle-Foot Orthosis (AFO) for patients with foot drop due to stroke, and to assess the functional improvement of ambulation and improved activities of daily living.

Detailed Description

This is a pivotal un-blinded, randomized, controlled trial with parallel group therapeutic intervention versus control of standard of care (AFO).

Conditions

Interventions

  • WalkAide Device
    Intervention Desc: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
    ARM 1: Kind: Experimental
    Label: WalkAide
    Description: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
  • Ankle-Foot Orthosis (AFO) Other
    Intervention Desc: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
    ARM 1: Kind: Experimental
    Label: Ankle-Foot Orthosis (AFO)

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary • Improved ambulation status, specific to increase in gait velocity (m/s), • Improved activities of daily living, rate of device related Serious Adverse Events 6 months No
Primary Gait Velocity 6 months No
Primary Stroke Impact Scale (SIS) Composite Score 6 months No
Primary Device Related Serious Adverse Events 6 months Yes
Secondary Six Minute Walk Test 6 months No
Secondary Modified Emory Functional Ambulation Profile Total Score 6 months No
Secondary Modified Emory Functional Ambulation Profile Floor Time 6 months No
Secondary Modified Emory Functional Ambulation Profile Carpet Time 6 months No
Secondary Modified Emory Functional Ambulation Profile Timed up and Go 6 months No
Secondary Modified Emory Functional Ambulation Profile Obstacle Course 6 months No
Secondary Modified Emory Functional Ambulation Profile Stair Time 6 months No
Secondary Berg Balance Scale 6 months No

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