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Very Intensive Variable Repetitive AmbulatioN Training

Very Intensive Variable Repetitive AmbulatioN Training

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02507466
Acronym
VIVRANT
Enrollment
90
Registered
2015-07-24
Start date
2015-07-31
Completion date
2019-10-31
Last updated
2020-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

locomotion

Brief summary

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.

Interventions

BEHAVIORALexercise

Variable conditions of stepping practice

Sponsors

Shirley Ryan AbilityLab
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

3 arm RCT - high intensity variable, high intensity forward, low intensity variable

Eligibility

Sex/Gender
ALL
Age
30 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in peak walking speedAt baseline, following 8 weeks of training and a 2 month follow-upfastest comfortable walking speed overground

Secondary

MeasureTime frameDescription
Change in Functional Gait AssessmentAt baseline, following 8 weeks of training and a 2 month follow-updynamic balance activities
Change in 5X sit-to-stand transfer timeAt baseline, following 8 weeks of training and a 2 month follow-upnon-walking functional mobility task

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026