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Very Intensive Variable Repetitive AmbulatioN Training (VIVRANT)

Shirley Ryan AbilityLab logo

Shirley Ryan AbilityLab

Status

Completed

Conditions

Stroke

Treatments

Behavioral: exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT02507466
STU00103739

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

30 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

90 participants in 3 patient groups

Variable high-intensity Training
Experimental group
Description:
high intensity variable stepping exercise on a treadmill and overground
Treatment:
Behavioral: exercise
Variable low-intensity training
Active Comparator group
Description:
low intensity variable stepping exercise on a treadmill and overground
Treatment:
Behavioral: exercise
Constant High Intensity Training
Active Comparator group
Description:
high intensity constant (forward) stepping exercise on a treadmill and overground
Treatment:
Behavioral: exercise

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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