Improving Ambulation Post Stroke With Robotic Training

Completed

Phase N/A Results

Trial Description

The purpose of this research study is to look at a new rehabilitation technique for individuals who have suffered a stroke and have difficulties walking. This study is designed to compare robot-assisted (Lokomat) rehabilitation therapy with standard physical therapy in order to improve walking post-stroke. This research project will be conducted as a pilot randomized controlled trial that compares the effectiveness of Lokomat versus conventional physical therapy in improving the ambulation and gait of chronic stroke patients. The project will provide important pilot data that could indicate whether or not the effectiveness of Lokomat training is superior to that of standard physical therapy and if a definitive and larger clinical trial is warranted.

Conditions

Interventions

  • Physical therapy Other
    Intervention Desc: Conventional physical therapy
    ARM 1: Kind: Experimental
    Label: Standard of Care
    Description: Conventional physical therapy
  • Lokomat Device
    Intervention Desc: Robotic-assisted walking device
    ARM 1: Kind: Experimental
    Label: Lokomat Intervention

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 10-meter Walking Test Baseline, Post-Intervention, 3-Month Post-Intervention Yes
Secondary 6 Minute Walking Test Baseline, Post-Intervention, 3-Month Post-Intervention Yes
Primary 10-meter Walking Test (10mWT) Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention Yes
Secondary 6 Minute Walking Distance (6MWD) Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention Yes

Sponsors