Very Intensive Variable Repetitive AmbulatioN Training (VIVRANT)

January 3, 2020 updated by: Thomas G Hornby, Shirley Ryan AbilityLab
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Rehabilitation Institute of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • history unilateral stroke > 6 months duration
  • walks without physical assistance at speeds < 1.0 m/s

Exclusion Criteria:

  • no other cardiopulmonary, metabolic, neurological orthopedic injury that may contribute to walking outcomes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Variable high-intensity Training
high intensity variable stepping exercise on a treadmill and overground
Behavioral: exercise
Variable conditions of stepping practice
Active Comparator: Variable low-intensity training
low intensity variable stepping exercise on a treadmill and overground
Behavioral: exercise
Variable conditions of stepping practice
Active Comparator: Constant High Intensity Training
high intensity constant (forward) stepping exercise on a treadmill and overground
Behavioral: exercise
Variable conditions of stepping practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in peak walking speed
Time Frame: At baseline, following 8 weeks of training and a 2 month follow-up
fastest comfortable walking speed overground
At baseline, following 8 weeks of training and a 2 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional Gait Assessment
Time Frame: At baseline, following 8 weeks of training and a 2 month follow-up
dynamic balance activities
At baseline, following 8 weeks of training and a 2 month follow-up
Change in 5X sit-to-stand transfer time
Time Frame: At baseline, following 8 weeks of training and a 2 month follow-up
non-walking functional mobility task
At baseline, following 8 weeks of training and a 2 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shirley Ryan AbilityLab

Investigators

  • Principal Investigator: Thomas Hornby, PT, PhD, RIC/NU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

July 21, 2015

First Submitted That Met QC Criteria

July 22, 2015

First Posted (Estimate)

July 24, 2015

Study Record Updates

Last Update Posted (Actual)

January 6, 2020

Last Update Submitted That Met QC Criteria

January 3, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STU00103739

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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