Very Intensive Variable Repetitive AmbulatioN Training

NCT ID: NCT02507466

Last Updated: 2020-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2019-10-31

Brief Summary

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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

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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

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3 arm RCT - high intensity variable, high intensity forward, low intensity variable
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Variable high-intensity Training

high intensity variable stepping exercise on a treadmill and overground

Group Type EXPERIMENTAL

exercise

Intervention Type BEHAVIORAL

Variable conditions of stepping practice

Variable low-intensity training

low intensity variable stepping exercise on a treadmill and overground

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type BEHAVIORAL

Variable conditions of stepping practice

Constant High Intensity Training

high intensity constant (forward) stepping exercise on a treadmill and overground

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type BEHAVIORAL

Variable conditions of stepping practice

Interventions

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exercise

Variable conditions of stepping practice

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shirley Ryan AbilityLab

OTHER

Sponsor Role lead

Responsible Party

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Thomas G Hornby

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Hornby, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

RIC/NU

Locations

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Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34695300 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32883192 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32507027 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31434543 (View on PubMed)

Other Identifiers

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STU00103739

Identifier Type: -

Identifier Source: org_study_id

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