Clinical trial NCT02507466: Very Intensive Variable Repetitive AmbulatioN Training
Official title: Very Intensive Variable Repetitive AmbulatioN Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: locomotion
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 arm RCT - high intensity variable, high intensity forward, low intensity variable
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in peak walking speed
timeFrame: At baseline, following 8 weeks of training and a 2 month follow-up
Secondary outcomes:
measure: Change in Functional Gait Assessment
timeFrame: At baseline, following 8 weeks of training and a 2 month follow-up
measure: Change in 5X sit-to-stand transfer time
timeFrame: At baseline, following 8 weeks of training and a 2 month follow-up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
Study officials:
affiliation: RIC/NU
name: Thomas Hornby, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.
citation: Hornby TG, Henderson CE, Holleran CL, Lovell L, Roth EJ, Jang JH. Stepwise Regression and Latent Profile Analyses of Locomotor Outcomes Poststroke. Stroke. 2020 Oct;51(10):3074-3082. doi: 10.1161/STROKEAHA.120.031065. Epub 2020 Sep 4.
citation: Ardestani MM, Henderson CE, Mahtani G, Connolly M, Hornby TG. Locomotor Kinematics and Kinetics Following High-Intensity Stepping Training in Variable Contexts Poststroke. Neurorehabil Neural Repair. 2020 Jul;34(7):652-660. doi: 10.1177/1545968320929675. Epub 2020 Jun 6.
citation: Hornby TG, Henderson CE, Plawecki A, Lucas E, Lotter J, Holthus M, Brazg G, Fahey M, Woodward J, Ardestani M, Roth EJ. Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke. Stroke. 2019 Sep;50(9):2492-2499. doi: 10.1161/STROKEAHA.119.026254. Epub 2019 Aug 22.