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Completed

NCT Number: NCT02507466

Very Intensive Variable Repetitive AmbulatioN Training

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

Variable conditions of stepping practice

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in Functional Gait Assessment

    Time frame: At baseline, following 8 weeks of training and a 2 month follow-up

    dynamic balance activities

  2. 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

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Acronym: VIVRANT

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 24, 2015
Registry last updated
Jan 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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