Very Intensive Variable Repetitive AmbulatioN Training "VIVRANT"

Recruiting

Phase N/A Results N/A

Trial Description

The overall objective of this subproject is to evaluate the individual and paired contributions of intensity and variability of stepping training on lower extremity (LE) function, health and community participation in patients with chronic hemiparesis post-stroke.

Detailed Description

The overall objective of this subproject is to evaluate the individual and paired contributions of intensity and variability of stepping training on lower extremity (LE) function, health and community participation in patients with chronic hemiparesis post-stroke. Using a RCT design/Intervention Efficacy paradigm, Aim 1 will investigate the independent and combined (paired) contributions of intensity and variability of stepping training on locomotor function, with secondary measures of health and community mobility. For Aim 2, we will evaluate the independent and combined effects of intensity and variability of stepping training on non-walking LE tasks. In Aim 3, we will evaluate the cost effectiveness of providing these interventions to accelerate motor recovery and health. Our central hypothesis is that results of this study will provide a theoretical foundation for implementation of physical therapy interventions which can facilitate short-term gains in locomotor function, and contribute to long-term improvements in health, function and participation through increased community mobility.

Conditions

Interventions

  • Exercise Behavioral
    Intervention Desc: Variable conditions of stepping practice
    ARM 1: Kind: Experimental
    Label: Variable high-intensity Training
    Description: high intensity variable stepping exercise on a treadmill and overground
    ARM 2: Kind: Experimental
    Label: Variable low-intensity training
    Description: low intensity variable stepping exercise on a treadmill and overground
    ARM 3: Kind: Experimental
    Label: Constant High Intensity Training
    Description: high intensity constant (forward) stepping exercise on a treadmill and overground

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in peak walking speed At baseline, following 8 weeks of training and a 2 month follow-up No
Secondary Change in Functional Gait Assessment At baseline, following 8 weeks of training and a 2 month follow-up No
Secondary Change in 5X sit-to-stand transfer time At baseline, following 8 weeks of training and a 2 month follow-up No

Sponsors