Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

Recruiting

Phase N/A Results N/A

Trial Description

The purpose of this study is to evaluate the safety and effectiveness of the Indego exoskeleton as a gait training tool for individuals with hemiplegia due to Cerebrovascular Accident (CVA).

Conditions

Interventions

  • Indego Exoskeleton Device
    Intervention Desc: Six study sessions including five Indego training sessions over two weeks.
    ARM 1: Kind: Experimental
    Label: All Enrolled Subjects
    Description: All enrolled subjects will receive gait training with the Indego.

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety of individuals with hemiplegia due to CVA using the Indego measured through reported Subject Adverse Events and Serious Adverse Events 2 weeks
Secondary Spasticity of bilateral upper and lower extremities measured with Modified Ashworth Scale 2 weeks
Secondary Activity measured by Functional Ambulation Category 2 weeks
Secondary Gait speed (without Indego) measured with 10 Meter Walk Test 2 weeks
Secondary Pain measured with Face, Legs, Activity, Cry, Consolability Scale 2 weeks

Sponsors