Very Intensive Variable Repetitive AmbulatioN Training

Stroke Clinical Trial

— VIVRANT  

Official title:

Very Intensive Variable Repetitive AmbulatioN Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507466
• Other study ID #: STU00103739
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: October 2019

Study information

• Verified date: January 2020
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• exercise
Variable conditions of stepping practice

Locations

Country	Name	City	State
United States	Rehabilitation Institute of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in peak walking speed	fastest comfortable walking speed overground	At baseline, following 8 weeks of training and a 2 month follow-up
Secondary	Change in Functional Gait Assessment	dynamic balance activities	At baseline, following 8 weeks of training and a 2 month follow-up
Secondary	Change in 5X sit-to-stand transfer time	non-walking functional mobility task	At baseline, following 8 weeks of training and a 2 month follow-up